Allergic Rhinitis Due to Weed PollenPhase 1NCT06038279
Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.
A Phase 1 study testing INI-2004 in people with Allergic Rhinitis Due to Weed Pollen and Allergic Rhinitis, run by Inimmune Corporation at 1 site in Australia.
Trial summary
This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses. This study will be conducted in two parts: Phase I single ascending dose (SAD) and Phase Ib multiple ascending dose (MAD). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis Due to Weed Pollen, Allergic Rhinitis
- What is being tested?
- INI-2004
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Jul 2023to 5 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing to refrain from consuming food or beverages containing caffeine and/or xanthene products, within 24 hours prior to check-in on Day -1.
- Female participants must be of non-child-bearing potential i.e., surgically sterilised at least 6 weeks before the screening visit or postmenopausal.
- Minimum 2 year history of ragweed-induced AR requiring pharmacotherapy (self-reported history accepted) and a positive ragweed skin prick test reaction at Screening Visit.
- Participant is willing to refrain from consuming food or beverages containing caffeine, within 24 hours prior to each clinic visit.
- Female participants must be of non-child-bearing potential i.e., surgically sterilised or postmenopausal.
Who cannot join
- Hypersensitivity or other clinically significant reaction to the study drug or its active ingredients.
- Current treatment or use of any prescription medication within 14 days prior to admission to the clinic on Day -1 of active seasonal and perennial allergic rhinitis, non-allergic rhinitis, rhinosinusitis, or asthma. This includes antihistamines, asthma preventers and relievers, nasal decongestants, IN corticosteroids, and immunotherapy or use of over-the-counter medication/vitamins/supplements within 7 days prior to the first dose of study drug. Exceptions include contraception, paracetamol and standard doses of multivitamins.
- Any clinically relevant structural nasal abnormalities, i.e., nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds, upper respiratory tract infection within 2 weeks prior to screening or first dose administration.
- History of recurrent migraine headaches within 4 weeks prior to screening.
- Positive alcohol breath, urine test, HBsAg, HepC virus antibody, or HIV antibody tests.
- Participant has donated blood or blood products within 3 months prior to first dose administration.
- Use of tobacco products or nicotine-containing products (including smoking cessation aids such as gum or patches.
- Participant plans to travel to an area with known environmental ragweed exposures at any time during study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.
This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses. This study will be conducted in two parts: Phase I single ascending dose (SAD) and Phase Ib multiple ascending dose (MAD).
Read the detailed description
This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses.
Phase I (SAD) - Healthy Participants will be enrolled and randomised to 4 dose cohorts (n=8 per cohort) to receive single ascending doses of INI-2004 or placebo (ratio 3:1 active: placebo). Dosing in each cohort will commence with two sentinels, with one of the two sentinels randomised to receive INI-2004 and the other randomised to receive placebo. The safety and tolerability of each sentinel participant will be monitored in the clinic until Day 2 and will be reviewed by the Principal Investigator (PI) prior to dosing the remainder of participants in each cohort. The decision to escalate between cohorts will be made by a safety review committee (SRC) following completion of the Day 3 visit for at least 6 out of 8 participants in the cohort. Cohorts will be dosed in an escalating order.
Phase Ib (MAD) - Phase Ib (MAD) may commence following completion of SAD Cohort 3 or SAD Cohort 4.
Up to 3 dose levels are planned to be evaluated. To be eligible for study inclusion, participants must have a positive response to the ragweed nasal allergen challenge at screening. Cohorts will be dosed in escalating order, with participants in each cohort (up to n=12 per cohort) randomised in blocks of 4 subjects to receive INI-2004 or placebo at a ratio of 3:1 (active:placebo). INI-2004 or placebo will be administered QW, commencing 2 weeks after administration of the second ragweed nasal allergen challenge.
- Being tested
- INI-2004, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INI-2004Drug
INI-2004 (a toll-like receptor [TLR]4 agonist) liposomal formulation. INI-2004 is an intranasal (IN) TLR4 agonist that is targeted to prevent AR symptoms in subjects with seasonal AR.
PlaceboDrug
Also called Placebo for INI-2004
The Placebo for INI-2004 is a clear, colorless solution free of particles supplied in 10 mL glass vials with a 10 mL fill.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (SAD)- INI-2004 Dose Cohort 1 | Experimental | Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo). Receives: Drug: INI-2004 |
| Arm 2 (SAD)- INI-2004 Dose Cohort 2 | Experimental | Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo). Receives: Drug: INI-2004 |
| Arm 3 (SAD)- INI-2004 Dose Cohort 3 | Experimental | Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo). Receives: Drug: INI-2004 |
| Arm 4 (SAD)- INI-2004 Dose Cohort 4 | Experimental | Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo). Receives: Drug: INI-2004 |
| Placebo | Placebo comparator | Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo). Receives: Drug: Placebo |
| Arm 1 (MAD) - INI-2004 Dose Cohort 1 | Experimental | Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks. Receives: Drug: INI-2004 |
| Arm 2 (MAD) -INI-2004 Dose Cohort 2 | Experimental | Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks. Receives: Drug: INI-2004 |
| Arm 3 (MAD) - INI-2004 Dose Cohort 3 | Experimental | Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks. Receives: Drug: INI-2004 |
| Placebo (MAD) | Placebo comparator | Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment after a single ascending Dose (SAD)
Graded using 5-point scale
Measured: Baseline, Day 1 then daily through to Day 7 End of Study Visit
Incidence, severity and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment after multiple ascending doses (MAD)
Graded using 5-point scale
Measured: Baseline = Day 0, Day 14, 21, 28, 35 through to Day 58 End of Study Visit
Number of Participants with a Change from baseline in Vital signs measurements after a single ascending Dose (SAD)
Pulse rate [PR], systolic and diastolic blood pressure [BP], temperature, respiratory rate.[RR] and oxygen saturation. Blood pressure will be measured using a sphygmomanometer, body temperature will be measured using a thermometer, Heart rate (HR) is measured using vital sign machine, respiratory rate is measured manually via 60-second count and oxygen saturation is measured using a Oximeter. All abnormal assessments measured as Clinically significant post dose will be recorded as AEs.
Measured: Baseline, Day 1 through to Day 7 End of Study Visit
Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses (MAD)
Pulse rate [PR], systolic and diastolic blood pressure [BP], temperature, respiratory rate.[RR] and oxygen saturation. Blood pressure will be measured using a sphygmomanometer, body temperature will be measured using a thermometer, Heart rate (HR) is measured using vital sign machine,respiratory rate is measured manually via 60-second count.[RR] and oxygen saturation is measured using a Oximeter. All abnormal assessments measured as Clinically significant post dose will be recorded as AEs.
Measured: Baseline = Day 0 through to Day 58 End of Study Visit
Change from baseline in 12-lead electrocardiogram parameters after a single ascending Dose (SAD)
12-lead ECGs parameters include but not limited to the measurements of ventricular HR, PR interval, RR interval, QRS duration, QT interval and QTcF. At each protocol scheduled timepoint, ECGs will be performed in triplicate with each replicate separated by at least 1 minute and the full set of triplicates completed within 5 minutes.All Clinically Significant findings post-dose will be recorded as AEs.
Measured: Baseline, Day 1 through to Day 7 End of Study Visit
Change from baseline in 12-lead electrocardiogram parameters after multiple ascending doses (MAD)
12-lead ECGs parameters include but not limited to the measurements of ventricular HR, PR interval, RR interval, QRS duration, QT interval and QTcF. At each protocol scheduled timepoint, ECGs will be performed in triplicate with each replicate separated by at least 1 minute and the full set of triplicates completed within 5 minutes.All Clinically Significant findings post-dose will be recorded as AEs.
Measured: Baseline = Day 0 through to Day 58 End of Study Visit
Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
Hematology - Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse events. The severity of each AE and SAE will be graded using a 5-point scale
Measured: Baseline, Day 2 through to Day 7 End of Study Visit
Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
Serum chemistry- Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
Measured: Baseline, Day 2 through to Day 7 End of Study Visit
Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
Urinalysis- Urine samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
Measured: Baseline, Day 2 through to Day 7 End of Study Visit
Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
Hematology - Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
Measured: Baseline = Day 0, Day 14 and Day 58 End of Study Visit
Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
Serum chemistry- Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
Measured: Baseline = Day 0, Day 14 and Day 58 End of Study Visit
Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
Urinalysis- Urine samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
Measured: Baseline = Day 0, Day 14 and Day 58 End of Study Visit
Change from baseline in Nasal symptoms after a single ascending Dose (SAD)
Presence of itching, discomfort, rhinorrhoea, congestion and sneezing are assessed using a 10 cm visual analogue scale [VAS]. The participant will mark on the VAS where they rank their symptoms ranging from "no symptoms" to "worst symptoms ever experienced".
Measured: Baseline, Day 1 through to Day 7 End of Study Visit
Change from baseline in Nasal symptoms after multiple ascending doses (MAD)
Presence of itching, discomfort, rhinorrhoea, congestion and sneezing are assessed individually as a Total Nasal Symptoms Score (TNSS) at different time points pre and post-ragweed allergen challenge in the MAD portion of the study. TNSS is the sum of symptoms scores for nasal congestion, rhinorrhoea, nasal itching, and sneezing (each scored on a scale of 0 to 3 (below) with total possible score of 0 to 12. The criterion used to score each symptom is described below:
0 = none: no symptoms
- = mild
- = moderate
- = severe
Measured: Baseline = Day 0 through to Day 58 End of Study Visit
Change from baseline in Nasal irritancy after a single ascending Dose (SAD)
Nasal examination
Measured: Baseline, Day 1 through to Day 7 End of Study Visit
Change from baseline in Nasal irritancy after multiple ascending doses (MAD)
Nasal examination
Measured: Baseline = Day 0 through to Day 58 End of Study Visit
Change from baseline in Spirometry after a single ascending Dose (SAD)
Peak expiratory flow [PEF]-Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for PEF will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for PEF is l/min.
Measured: Baseline, Day 1 through to Day 7 End of Study Visit
Change from baseline in Spirometry after a single ascending Dose (SAD)
Forced expiratory volume in 1 second [FEV1]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEV1 will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1 is liters.
Measured: Baseline, Day 1 through to Day 7 End of Study Visit
Change from baseline in Spirometry after a single ascending Dose (SAD)
Forced vital capacity [FVC]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FVC will be summarised at each scheduled time point using descriptive statistics. Units of measurement used for FVC is liters.
Measured: Baseline, Day 1 through to Day 7 End of Study Visit
Change from baseline in Spirometry after a single ascending Dose (SAD)
Forced expiratory flow over the middle one-half of the FVC [FEF25-75%]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for spirometry assessments FEF25-75% will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1/FVC is %.
Measured: Baseline, Day 1 through to Day 7 End of Study Visit
Change from baseline in Spirometry after a single ascending Dose (SAD)
FEV1/FVC ratio- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for spirometry assessments FEV1/FVC ratio will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEF 25%-75% is l/s.
Measured: Baseline, Day 1 through to Day 7 End of Study Visit
Change from baseline in Spirometry after multiple ascending doses (MAD)
Peak expiratory flow [PEF]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for PEF will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for PEF is l/min.
Measured: Baseline = Day 0 through to Day 58 End of Study Visit
Change from baseline in Spirometry after multiple ascending doses (MAD)
Forced expiratory volume in 1 second [FEV1]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEV1 will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1 is liters.
Measured: Baseline = Day 0 through to Day 58 End of Study Visit
Change from baseline in Spirometry after multiple ascending doses (MAD)
Forced vital capacity [FVC]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FVC will be summarised at each scheduled time point using descriptive statistics. Units of measurement used for FVC is liters.
Measured: Baseline = Day 0 through to Day 58 End of Study Visit
Change from baseline in Spirometry after multiple ascending doses (MAD)
FEF25-75% - Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEF25-75%, will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1/FVC is %.
Measured: Baseline = Day 0 through to Day 58 End of Study Visit
Change from baseline in Spirometry after multiple ascending doses (MAD)
FEV1/FVC ratio- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEV1/FVC ratio will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEF 25%-75% is l/s.
Measured: Baseline = Day 0 through to Day 58 End of Study Visit
Secondary outcomes (24)
Effectiveness of INI-2004 on nasal congestion will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 14, 21, 23, 28, 35, 37, 51 and 58 compared to baseline (Day 0)
Determined by acoustic rhinometry. Acoustic rhinometry will be performed using GM Instruments. Measurements to include (at a minimum) nasal volume and cross-sectional area. Measurements will be performed for both left and right nasal cavities independently.
Measured: Baseline = Day 0 through to Day 58
Effectiveness of INI-2004 on peak nasal inspiratory flow will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 14, 21, 23, 28, 35, 37, 51 and 58 compared to baseline (Day 0)
Peak nasal inspiratory flow to be determined using the mean of three replicates.
Measured: Baseline = Day 0 through to Day 58
Effectiveness of INI-2004 on nasal symptoms will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0)
Total nasal symptom score [TNSS] will be measured on a scale of 0 to 3 with a total possible score of 0 to 12. 0= none, no symptoms, 1= mild, 2= moderate, 3=severe.
Measured: Baseline = Day 0 through to Day 58
Effectiveness of INI-2004 on nasal irritancy will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0)
Nasal examination- A macroscopic nasal examination will be performed, including conventional anterior rhinoscopy using an otoscope with an attached otic speculum (or nasal speculum and headlight) to assess swelling of the mucosa, erythema, and secretions. All post-dose CS events will be recorded as AEs.
Measured: Baseline = Day 0 through to Day 58 End of Study Visit
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51, and 58 compared to baseline (Day 0) via PEF
PEF- Unit of measurement or PEFis l/min
Measured: Baseline = Day 0 through to Day 58
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) Via FEV1
FEV1- FEV1 is measured in liters
Measured: Baseline = Day 0 through to Day 58
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FVC
FVC is measured in liters
Measured: Baseline = Day 0 through to Day 58
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FEV1/FVC ratio
FEV1/FVC- is measured in %
Measured: Baseline = Day 0 through to Day 58
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FEF
FEF 25%-75%- is measured as l/s
Measured: Baseline = Day 0 through to Day 58
Single dose PK parameters: maximum observed concentration (Cmax)
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
Measured: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Time to Cmax (Tmax)
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
Measured: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Area under the concentration-time curve from time 0 to time t (AUC0-t)
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
Measured: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast)
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
Measured: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Half-life (t1/2)
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
Measured: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Clearance (Cl/f)
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
Measured: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Volume of distribution (Vz/f)
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
Measured: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Area under the drug concentration-time curve from time zero infinity (AUCinf)
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
Measured: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Multiple dose PK parameters: Drug concentrations from pre-dose to 4 hours post-dose on Days 14 and 35.
Pharmacokinetics (PK) of INI-2004 in blood plasma following multiple doses
Measured: Day 14 pre dose then 1, 2 and 4 hours post-dose, Day 35 pre dose then 1, 2 and 4 hours post-dose
Multiple dose PK parameters: AUC0-4 on Days 14 and 35 (if data permits)
Pharmacokinetics (PK) of INI-2004 in blood plasma following multiple doses
Measured: Day 14 pre dose then 1, 2 and 4 hours post-dose, Day 35 pre dose then 1, 2 and 4 hours post-dose
Multiple dose PK parameters: Post-dose urine drug concentration on Day 14.
Pharmacokinetics (PK) of INI-2004 in urine following multiple doses - decision if endpoint will be evaluated will be determined following review of plasma PK data from Phase I (SAD).
Measured: Urine to be collected at 0-2 hours post-dose interval on Day 14 only.
Single dose PD parameters: Changes in cytokine levels in nasal secretions post-dose compared to baseline pre-dose.
Pharmacodynamics (PD) of INI-2004 in nasal secretions following single dose
Measured: Baseline Day 1 pre-dose then 4, 24 and 48 hours post-dose.
Single dose PD parameters: Changes in cytokine levels in plasma post-dose compared to baseline pre-dose.
Pharmacodynamics (PD) of INI-2004 in blood plasma following single dose
Measured: Baseline Day 1 pre-dose then 4, 24 and 48 hours post-dose.
Multiple dose PD parameters: Changes in concentrations of pro-inflammatory cytokines and nasal mediators in nasal secretions following dose administration compared to baseline pre-dose.
Pharmacodynamics (PD) of INI-2004 in nasal secretions following multiple doses
Measured: Baseline pre-dose on Day 14 and 35, post-dose Days 14 and 35.
Multiple dose PD parameters: Changes in concentrations of pro-inflammatory cytokines and nasal mediators in plasma following dose administration compared to baseline pre-dose.
Pharmacodynamics (PD) of INI-2004 in blood plasma following multiple doses
Measured: Baseline pre-dose on Day 14 and 35, post-dose Days 14 and 35.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start4 Jul 2023
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to Weed PollenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses.This study will be conducted in two parts: Phase I (SAD) and Phase Ib (MAD).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inimmune Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- JonL. Ruckle, Study director, Inimmune Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038279
- Sponsor's protocol ID
- INI-2004-101
- Status last verified
- Sep 2023
- First submitted
- 31 Jul 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT06038279
- Acronym / sponsor ID
- INI-2004-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Inimmune CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses. This study will be conducted in two parts: Phase I single ascending dose (SAD) and Phase Ib multiple ascending dose (MAD).
Detailed description
This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses.
Phase I (SAD) - Healthy Participants will be enrolled and randomised to 4 dose cohorts (n=8 per cohort) to receive single ascending doses of INI-2004 or placebo (ratio 3:1 active: placebo). Dosing in each cohort will commence with two sentinels, with one of the two sentinels randomised to receive INI-2004 and the other randomised to receive placebo. The safety and tolerability of each sentinel participant will be monitored in the clinic until Day 2 and will be reviewed by the Principal Investigator (PI) prior to dosing the remainder of participants in each cohort. The decision to escalate between cohorts will be made by a safety review committee (SRC) following completion of the Day 3 visit for at least 6 out of 8 participants in the cohort. Cohorts will be dosed in an escalating order.
Phase Ib (MAD) - Phase Ib (MAD) may commence following completion of SAD Cohort 3 or SAD Cohort 4.
Up to 3 dose levels are planned to be evaluated. To be eligible for study inclusion, participants must have a positive response to the ragweed nasal allergen challenge at screening. Cohorts will be dosed in escalating order, with participants in each cohort (up to n=12 per cohort) randomised in blocks of 4 subjects to receive INI-2004 or placebo at a ratio of 3:1 (active:placebo). INI-2004 or placebo will be administered QW, commencing 2 weeks after administration of the second ragweed nasal allergen challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses.This study will be conducted in two parts: Phase I (SAD) and Phase Ib (MAD).
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (SAD)- INI-2004 Dose Cohort 1 | Experimental | Drug: INI-2004Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo). |
| Arm 2 (SAD)- INI-2004 Dose Cohort 2 | Experimental | Drug: INI-2004Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo). |
| Arm 3 (SAD)- INI-2004 Dose Cohort 3 | Experimental | Drug: INI-2004Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo). |
| Arm 4 (SAD)- INI-2004 Dose Cohort 4 | Experimental | Drug: INI-2004Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo). |
| Placebo | Placebo comparator | Drug: PlaceboHealthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo). |
| Arm 1 (MAD) - INI-2004 Dose Cohort 1 | Experimental | Drug: INI-2004Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks. |
| Arm 2 (MAD) -INI-2004 Dose Cohort 2 | Experimental | Drug: INI-2004Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks. |
| Arm 3 (MAD) - INI-2004 Dose Cohort 3 | Experimental | Drug: INI-2004Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks. |
| Placebo (MAD) | Placebo comparator | Drug: PlaceboParticipants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant is willing to refrain from consuming food or beverages containing caffeine and/or xanthene products, within 24 hours prior to check-in on Day -1.
- Female participants must be of non-child-bearing potential i.e., surgically sterilised at least 6 weeks before the screening visit or postmenopausal.
- Minimum 2 year history of ragweed-induced AR requiring pharmacotherapy (self-reported history accepted) and a positive ragweed skin prick test reaction at Screening Visit.
- Participant is willing to refrain from consuming food or beverages containing caffeine, within 24 hours prior to each clinic visit.
- Female participants must be of non-child-bearing potential i.e., surgically sterilised or postmenopausal.
Key exclusion criteria (8 listed)
- Hypersensitivity or other clinically significant reaction to the study drug or its active ingredients.
- Current treatment or use of any prescription medication within 14 days prior to admission to the clinic on Day -1 of active seasonal and perennial allergic rhinitis, non-allergic rhinitis, rhinosinusitis, or asthma. This includes antihistamines, asthma preventers and relievers, nasal decongestants, IN corticosteroids, and immunotherapy or use of over-the-counter medication/vitamins/supplements within 7 days prior to the first dose of study drug. Exceptions include contraception, paracetamol and standard doses of multivitamins.
- Any clinically relevant structural nasal abnormalities, i.e., nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds, upper respiratory tract infection within 2 weeks prior to screening or first dose administration.
- History of recurrent migraine headaches within 4 weeks prior to screening.
- Positive alcohol breath, urine test, HBsAg, HepC virus antibody, or HIV antibody tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INI-2004INI-2004 (a toll-like receptor [TLR]4 agonist) liposomal formulation. INI-2004 is an intranasal (IN) TLR4 agonist that is targeted to prevent AR symptoms in subjects with seasonal AR. | Drug | Arm 1 (MAD) - INI-2004 Dose Cohort 1, Arm 1 (SAD)- INI-2004 Dose Cohort 1, Arm 2 (MAD) -INI-2004 Dose Cohort 2, Arm 2 (SAD)- INI-2004 Dose Cohort 2, Arm 3 (MAD) - INI-2004 Dose Cohort 3, Arm 3 (SAD)- INI-2004 Dose Cohort 3, Arm 4 (SAD)- INI-2004 Dose Cohort 4 |
| PlaceboAlso: Placebo for INI-2004The Placebo for INI-2004 is a clear, colorless solution free of particles supplied in 10 mL glass vials with a 10 mL fill. | Drug | Placebo, Placebo (MAD) |
Primary outcome
Incidence, severity and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment after a single ascending Dose (SAD)
Time frame: Baseline, Day 1 then daily through to Day 7 End of Study Visit
Graded using 5-point scale
Incidence, severity and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment after multiple ascending doses (MAD)
Time frame: Baseline = Day 0, Day 14, 21, 28, 35 through to Day 58 End of Study Visit
Graded using 5-point scale
Number of Participants with a Change from baseline in Vital signs measurements after a single ascending Dose (SAD)
Time frame: Baseline, Day 1 through to Day 7 End of Study Visit
Pulse rate [PR], systolic and diastolic blood pressure [BP], temperature, respiratory rate.[RR] and oxygen saturation. Blood pressure will be measured using a sphygmomanometer, body temperature will be measured using a thermometer, Heart rate (HR) is measured using vital sign machine, respiratory rate is measured manually via 60-second count and oxygen saturation is measured using a Oximeter. All abnormal assessments measured as Clinically significant post dose will be recorded as AEs.
Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses (MAD)
Time frame: Baseline = Day 0 through to Day 58 End of Study Visit
Pulse rate [PR], systolic and diastolic blood pressure [BP], temperature, respiratory rate.[RR] and oxygen saturation. Blood pressure will be measured using a sphygmomanometer, body temperature will be measured using a thermometer, Heart rate (HR) is measured using vital sign machine,respiratory rate is measured manually via 60-second count.[RR] and oxygen saturation is measured using a Oximeter. All abnormal assessments measured as Clinically significant post dose will be recorded as AEs.
Change from baseline in 12-lead electrocardiogram parameters after a single ascending Dose (SAD)
Time frame: Baseline, Day 1 through to Day 7 End of Study Visit
12-lead ECGs parameters include but not limited to the measurements of ventricular HR, PR interval, RR interval, QRS duration, QT interval and QTcF. At each protocol scheduled timepoint, ECGs will be performed in triplicate with each replicate separated by at least 1 minute and the full set of triplicates completed within 5 minutes.All Clinically Significant findings post-dose will be recorded as AEs.
Change from baseline in 12-lead electrocardiogram parameters after multiple ascending doses (MAD)
Time frame: Baseline = Day 0 through to Day 58 End of Study Visit
12-lead ECGs parameters include but not limited to the measurements of ventricular HR, PR interval, RR interval, QRS duration, QT interval and QTcF. At each protocol scheduled timepoint, ECGs will be performed in triplicate with each replicate separated by at least 1 minute and the full set of triplicates completed within 5 minutes.All Clinically Significant findings post-dose will be recorded as AEs.
Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
Time frame: Baseline, Day 2 through to Day 7 End of Study Visit
Hematology - Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse events. The severity of each AE and SAE will be graded using a 5-point scale
Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
Time frame: Baseline, Day 2 through to Day 7 End of Study Visit
Serum chemistry- Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
Time frame: Baseline, Day 2 through to Day 7 End of Study Visit
Urinalysis- Urine samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
Time frame: Baseline = Day 0, Day 14 and Day 58 End of Study Visit
Hematology - Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
Time frame: Baseline = Day 0, Day 14 and Day 58 End of Study Visit
Serum chemistry- Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
Time frame: Baseline = Day 0, Day 14 and Day 58 End of Study Visit
Urinalysis- Urine samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
Change from baseline in Nasal symptoms after a single ascending Dose (SAD)
Time frame: Baseline, Day 1 through to Day 7 End of Study Visit
Presence of itching, discomfort, rhinorrhoea, congestion and sneezing are assessed using a 10 cm visual analogue scale [VAS]. The participant will mark on the VAS where they rank their symptoms ranging from "no symptoms" to "worst symptoms ever experienced".
Change from baseline in Nasal symptoms after multiple ascending doses (MAD)
Time frame: Baseline = Day 0 through to Day 58 End of Study Visit
Presence of itching, discomfort, rhinorrhoea, congestion and sneezing are assessed individually as a Total Nasal Symptoms Score (TNSS) at different time points pre and post-ragweed allergen challenge in the MAD portion of the study. TNSS is the sum of symptoms scores for nasal congestion, rhinorrhoea, nasal itching, and sneezing (each scored on a scale of 0 to 3 (below) with total possible score of 0 to 12. The criterion used to score each symptom is described below: 0 = none: no symptoms 1. = mild 2. = moderate 3. = severe
Change from baseline in Nasal irritancy after a single ascending Dose (SAD)
Time frame: Baseline, Day 1 through to Day 7 End of Study Visit
Nasal examination
Change from baseline in Nasal irritancy after multiple ascending doses (MAD)
Time frame: Baseline = Day 0 through to Day 58 End of Study Visit
Nasal examination
Change from baseline in Spirometry after a single ascending Dose (SAD)
Time frame: Baseline, Day 1 through to Day 7 End of Study Visit
Peak expiratory flow [PEF]-Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for PEF will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for PEF is l/min.
Change from baseline in Spirometry after a single ascending Dose (SAD)
Time frame: Baseline, Day 1 through to Day 7 End of Study Visit
Forced expiratory volume in 1 second [FEV1]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEV1 will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1 is liters.
Change from baseline in Spirometry after a single ascending Dose (SAD)
Time frame: Baseline, Day 1 through to Day 7 End of Study Visit
Forced vital capacity [FVC]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FVC will be summarised at each scheduled time point using descriptive statistics. Units of measurement used for FVC is liters.
Change from baseline in Spirometry after a single ascending Dose (SAD)
Time frame: Baseline, Day 1 through to Day 7 End of Study Visit
Forced expiratory flow over the middle one-half of the FVC [FEF25-75%]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for spirometry assessments FEF25-75% will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1/FVC is %.
Change from baseline in Spirometry after a single ascending Dose (SAD)
Time frame: Baseline, Day 1 through to Day 7 End of Study Visit
FEV1/FVC ratio- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for spirometry assessments FEV1/FVC ratio will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEF 25%-75% is l/s.
Change from baseline in Spirometry after multiple ascending doses (MAD)
Time frame: Baseline = Day 0 through to Day 58 End of Study Visit
Peak expiratory flow [PEF]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for PEF will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for PEF is l/min.
Change from baseline in Spirometry after multiple ascending doses (MAD)
Time frame: Baseline = Day 0 through to Day 58 End of Study Visit
Forced expiratory volume in 1 second [FEV1]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEV1 will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1 is liters.
Change from baseline in Spirometry after multiple ascending doses (MAD)
Time frame: Baseline = Day 0 through to Day 58 End of Study Visit
Forced vital capacity [FVC]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FVC will be summarised at each scheduled time point using descriptive statistics. Units of measurement used for FVC is liters.
Change from baseline in Spirometry after multiple ascending doses (MAD)
Time frame: Baseline = Day 0 through to Day 58 End of Study Visit
FEF25-75% - Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEF25-75%, will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1/FVC is %.
Change from baseline in Spirometry after multiple ascending doses (MAD)
Time frame: Baseline = Day 0 through to Day 58 End of Study Visit
FEV1/FVC ratio- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEV1/FVC ratio will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEF 25%-75% is l/s.
24 secondary outcomes
Effectiveness of INI-2004 on nasal congestion will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 14, 21, 23, 28, 35, 37, 51 and 58 compared to baseline (Day 0)
Time frame: Baseline = Day 0 through to Day 58
Effectiveness of INI-2004 on peak nasal inspiratory flow will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 14, 21, 23, 28, 35, 37, 51 and 58 compared to baseline (Day 0)
Time frame: Baseline = Day 0 through to Day 58
Effectiveness of INI-2004 on nasal symptoms will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0)
Time frame: Baseline = Day 0 through to Day 58
Effectiveness of INI-2004 on nasal irritancy will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0)
Time frame: Baseline = Day 0 through to Day 58 End of Study Visit
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51, and 58 compared to baseline (Day 0) via PEF
Time frame: Baseline = Day 0 through to Day 58
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) Via FEV1
Time frame: Baseline = Day 0 through to Day 58
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FVC
Time frame: Baseline = Day 0 through to Day 58
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FEV1/FVC ratio
Time frame: Baseline = Day 0 through to Day 58
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FEF
Time frame: Baseline = Day 0 through to Day 58
Single dose PK parameters: maximum observed concentration (Cmax)
Time frame: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Time to Cmax (Tmax)
Time frame: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Area under the concentration-time curve from time 0 to time t (AUC0-t)
Time frame: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast)
Time frame: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Half-life (t1/2)
Time frame: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Clearance (Cl/f)
Time frame: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Volume of distribution (Vz/f)
Time frame: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Single dose PK parameters: Area under the drug concentration-time curve from time zero infinity (AUCinf)
Time frame: Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Multiple dose PK parameters: Drug concentrations from pre-dose to 4 hours post-dose on Days 14 and 35.
Time frame: Day 14 pre dose then 1, 2 and 4 hours post-dose, Day 35 pre dose then 1, 2 and 4 hours post-dose
Multiple dose PK parameters: AUC0-4 on Days 14 and 35 (if data permits)
Time frame: Day 14 pre dose then 1, 2 and 4 hours post-dose, Day 35 pre dose then 1, 2 and 4 hours post-dose
Multiple dose PK parameters: Post-dose urine drug concentration on Day 14.
Time frame: Urine to be collected at 0-2 hours post-dose interval on Day 14 only.
Single dose PD parameters: Changes in cytokine levels in nasal secretions post-dose compared to baseline pre-dose.
Time frame: Baseline Day 1 pre-dose then 4, 24 and 48 hours post-dose.
Single dose PD parameters: Changes in cytokine levels in plasma post-dose compared to baseline pre-dose.
Time frame: Baseline Day 1 pre-dose then 4, 24 and 48 hours post-dose.
Multiple dose PD parameters: Changes in concentrations of pro-inflammatory cytokines and nasal mediators in nasal secretions following dose administration compared to baseline pre-dose.
Time frame: Baseline pre-dose on Day 14 and 35, post-dose Days 14 and 35.
Multiple dose PD parameters: Changes in concentrations of pro-inflammatory cytokines and nasal mediators in plasma following dose administration compared to baseline pre-dose.
Time frame: Baseline pre-dose on Day 14 and 35, post-dose Days 14 and 35.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JonL. Ruckle study director
Inimmune Corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INI-2004 in people with Allergic Rhinitis Due to Weed Pollen and Allergic Rhinitis, run by Inimmune Corporation at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment after a single ascending Dose (SAD) (time frame: Baseline, Day 1 then daily through to Day 7 End of Study Visit). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.