Allergic DiseasePhase 1NCT07356713
A Study to Find a Suitable Dose of Exl-111 for Further Research
A Phase 1 study testing Exl-111 (SAD), Exl-111 (MAD) and Omalizumab in people with Allergic Disease, run by Excellergy Inc. at 2 sites in 2 countries.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of Exl-111 in healthy participants. The trials consists of 2 parts, as follows: Part A (SAD): Up to 5 dose cohorts, each with 8 participants, randomized into 2 arms: Exl-111 and placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Disease
- What is being tested?
- Exl-111 (SAD), Exl-111 (MAD) and Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Jan 2026to 7 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, male and female participants 18-55 years of age at Screening
- Body weight ≥45 kg and ≤120 kg and body mass index (BMI) 18 to ≤32 kg/m2 at Screening and Day -1
- Serum IgE ≥30 IU/mL and ≤300 IU/mL at Screening
- Nonsmoker and must not have used any tobacco products within 2 months prior to Screening. Participants who smoke ≤2 cigarettes or equivalent (e.g., cigars, vaping, nicotine patches) per week can be included in the trial at the discretion of the PI/delegate
- Positive skin prick test at Screening (Part B MAD Cohorts only) to common aeroallergens
- Willing and able to read, understand, and sign an informed consent form (ICF) that includes compliance with requirements and restrictions listed in the ICF and in this protocol
Who cannot join
- Received Exl-111 in a prior cohort in this trial
- Prior receipt of any anti-IgE therapy
- Use of any medication, including any prescription, over-the-counter, or other supplements, within 5 days prior to dosing, extending to 30 days after last dose of trial intervention, with the exception of those approved by the PI and Sponsor or Sponsor representative.
- Receipt of any small molecule investigational agent or trial intervention in a clinical trial within 30 days or 5 half-lives (whichever is longer) prior to Day 1
- Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or mAbs) within 3 months or 5 half-lives (whichever is longer) prior to Screening
- Receipt of either of the following:
Show all 29Show fewer
- Any live/unattenuated vaccinations within 12 weeks prior to Screening
- Non-living/attenuated vaccinations (including inactivated vaccines, messenger RNA vaccines) within 4 weeks prior to Screening
- History of active systemic infection within 30 days prior to Day 1
- Known history of positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus (HIV)-1 or HIV-2
- Positive test at Screening for HBsAg, hepatitis B core antibody (HBcAb), HCV Ab, HIV antibody, QuantiFERON®-TB Gold In-Tube test
- Active treatment for any allergic condition, except for over-the-counter (OTC) antihistamines for seasonal allergy subject to exclusion #11
- In Part B only, use of any drug that may interfere with the skin prick test results, including antihistamine use within 5 days before each skin prick test
- History of relevant drug hypersensitivity, or any confirmed significant allergic reactions (urticaria or anaphylaxis), as judged by the PI, against any drug, or multiple drug or food allergies.
- History of cardiac arrhythmia or family history of sudden cardiac death or a history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, hypomagnesia, or family history of Long QT Syndrome)
- Clinically relevant history of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, ophthalmological, or connective tissue diseases or disorders that, in the opinion of the PI, might pose additional risk to the participant or confound the results of the trial
- History of malignancy in the previous 5 years
- History of alcohol or substance use disorder within the previous 5 years
- History of vasovagal reactions
- History of hereditary alpha-tryptasemia
- Positive test result for alcohol or drugs of abuse at Screening or Day -1
- Clinical laboratory safety test results outside the local reference range at Screening or Day -1 which are deemed to be clinically significant by PI/delegate
- AST/ALT >1.5 × ULN or total bilirubin > ULN at Screening or Day -1 (excluding participants with documented history of Gilbert's syndrome)
- Screening or Day -1 estimated glomerular filtration rate <60 mL/min/1.73m2, according to the Chronic Kidney Disease Epidemiology Collaboration equation. Borderline results (±10 mL/min/1.73m2) may be acceptable based on PI's discretion.
- Screening or Day -1 supine blood pressure (BP) ≥160 mmHg (systolic) or ≥95 mmHg (diastolic), following at least 5 minutes of supine rest. If BP is ≥160 mmHg (systolic) or ≥95 mmHg (diastolic), the BP should be repeated 2 more times (at least 5 minutes between measures) and the average of the 3 BP values should be used to determine the participant's eligibility
- Screening supine 12-lead ECG demonstrates a QTcF interval >450 msec for male participants or >470 msec for female participants, or a QRSD interval >120 msec or any other relevant ECG finding at Screening. If the QTcF exceeds 450 msec, or QRSD exceeds 120 msec, the ECG should be repeated 2 more times (at least 5 minutes between measures) and the average of the 3 QTcF or QRSD values should be used to determine the participant's eligibility
- Pregnant, lactating, or breastfeeding, or plan to become pregnant while participating in the trial or within 30 days of the last dose of trial intervention
- Unwilling or unable to comply with the contraception requirements and lifestyle restrictions
- Employee of the Sponsor or the site or a relative of an employee at the site
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
CMAX
Adelaide, South Australia, 5000
Dr. Sepehr Shakib, +61870887900, cmax@cmax.com.au
Dr. Sepehr Shakib
New Zealand1 site, 1 recruiting
- Not yet recruiting
New Zealand Clinical Research OPCO Ltd
Auckland, 1010
Mary Ellis-Pegler, mary.ellis-pegler@nzcr.co.nz
Millie Wang, Dr
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial of Exl-111 in Healthy Participants
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of Exl-111 in healthy participants.
The trials consists of 2 parts, as follows:
Part A (SAD): Up to 5 dose cohorts, each with 8 participants, randomized into 2 arms: Exl-111 and placebo.
Part B (MAD): Up to 3 dose cohorts, each with 10 participants, randomized into 3 arms: Exl-111, placebo, and an active comparator (omalizumab).
Read the detailed description
Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of Exl-111 in healthy participants.
Part A : In all SAD cohorts, trial intervention will be administered as single SC injection on Day 1. Participants will remain in the clinic through Day 5 and will return to the clinic for multiple follow up visits through Day 141 (Week 20)/End of Study [EOS]). The trial may proceed to Part B if recommended by the Safety Monitoring committee (SMC) upon review of available Part A safety data as described below.
Part B: Part B may be initiated following approval by the SMC after the SMC meeting for SAD Cohort 3 in Part A, and SMC review of:
SAD cohort corresponding to the proposed MAD starting dose level and SAD cohort corresponding to the proposed dose above the MAD starting dose level Participants will remain in the clinic from Day -1 through Day 5 for the first dose, Days 28-31 for the second dose, Days 56-59 for the third dose, and Days 84-89 for the fourth dose. Following the last dose, participants will return to the clinic over multiple follow-up assessments through Day 196 (Week 28)/EOS, 16 weeks after the last dose.
- Conditions
- Allergic Disease
- Being tested
- Exl-111 (SAD), Exl-111 (MAD), Placebo, Omalizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exl-111 (SAD)Drug
Exl-111 is administered by subcutaneous injection in a single dose.
Exl-111 (MAD)Drug
Exl-111 is administered by subcutaneous injection in ascending dose levels.
PlaceboDrug
A placebo matched in appearance and route of administration to Exl-111 is given by subcutaneous injection
OmalizumabDrug
Omalizumab is administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Exl-111 (SAD) | Experimental | Healthy participants receive a single subcutaneous dose of Exl-111 at 5 ascending dose levels Receives: Drug: Exl-111 (SAD) |
| Exl-111 (MAD) | Experimental | Healthy participants receive Exl-111 at 3 ascending dose levels administered every 4 weeks (Q4W) for a total of 4 doses Receives: Drug: Exl-111 (MAD) |
| Placebo | Experimental | Participants receive placebo injections matched in appearance and schedule to Exl-111: a single SC dose in Part A (SAD) or SC doses Q4W x4 in Part B (MAD), according to their assigned cohort. Receives: Drug: Placebo |
| Comparator | Experimental | (MAD) Healthy participants receive omalizumab injections every 4 weeks (Q4W) for a total of 4 doses Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events and serious adverse events for Part A and Part B
This is to evaluate the safety and tolerability of single and multiple dose administration of Exl-111 in healthy participants
Measured: From first dose through Day 196.
Secondary outcomes (9)
Pharmacokinetic assessment of maximum observed plasma concentration (Cmax) of Exl-111
Maximum plasma concentration (Cmax)
Measured: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment of Time to Maximum Concentration (Tmax) of Exl-111
Time to Maximum Concentration (Tmax)
Measured: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment apparent Terminal Half-life (t1/2) of Exl-111
Terminal Half-life (t1/2)
Measured: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment observed volume of distribution associated with the terminal slope following administration of Exl-111. ( VZO)
Volume of distribution ( VZO)
Measured: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment area under the curve (AUC) from the time of dosing to the last measurable concentration of Exl-111. (AUCLST)
Area Under the Curve (AUC)
Measured: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the area under the curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration of Exl-111. (AUCIFO)
Area under the curve (AUC) based on the last observed concentration. (AUCIFO)
Measured: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the area under the curve (AUC) extrapolated to t from dosing time, based on tau of Exl-111. (AUCT)
Area Under the Curve Over the Dosing Interval (AUCT) Assessment
Measured: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the maximum concentration occurring at Tmax, divided by the dose of Exl-111. (CMAXD)
Dose-Normalized Maximum Plasma Concentration (Cmax/D)
Measured: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the area under the curve (AUC) for the defined interval between doses (TAU) divided by the dose of Exl-111. (AUCTAUD)
Pharmacokinetic assessment the area under the curve (AUC) for the defined interval Dose-Normalized Area Under the Curve Over the Dosing Interval (AUCTAUD)
Measured: From treatment Day 1 to EOS/ET Week 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start8 Jan 2026
- Primary completion7 Dec 2026 (estimated)
- Study completion7 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DiseaseStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excellergy Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356713
- Sponsor's protocol ID
- Exl-111.101
- Status last verified
- Sep 2026
- First submitted
- 11 Dec 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial of Exl-111 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07356713
- Acronym / sponsor ID
- Exl-111.101
- Conditions
- Allergic Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Excellergy Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 7 Dec 2026 (estimated)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 21 Jan 2026 (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 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of Exl-111 in healthy participants.
The trials consists of 2 parts, as follows:
Part A (SAD): Up to 5 dose cohorts, each with 8 participants, randomized into 2 arms: Exl-111 and placebo.
Part B (MAD): Up to 3 dose cohorts, each with 10 participants, randomized into 3 arms: Exl-111, placebo, and an active comparator (omalizumab).
Detailed description
Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of Exl-111 in healthy participants.
Part A : In all SAD cohorts, trial intervention will be administered as single SC injection on Day 1. Participants will remain in the clinic through Day 5 and will return to the clinic for multiple follow up visits through Day 141 (Week 20)/End of Study [EOS]). The trial may proceed to Part B if recommended by the Safety Monitoring committee (SMC) upon review of available Part A safety data as described below.
Part B: Part B may be initiated following approval by the SMC after the SMC meeting for SAD Cohort 3 in Part A, and SMC review of:
SAD cohort corresponding to the proposed MAD starting dose level and SAD cohort corresponding to the proposed dose above the MAD starting dose level Participants will remain in the clinic from Day -1 through Day 5 for the first dose, Days 28-31 for the second dose, Days 56-59 for the third dose, and Days 84-89 for the fourth dose. Following the last dose, participants will return to the clinic over multiple follow-up assessments through Day 196 (Week 28)/EOS, 16 weeks after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exl-111 (SAD) | Experimental | Drug: Exl-111 (SAD)Healthy participants receive a single subcutaneous dose of Exl-111 at 5 ascending dose levels |
| Exl-111 (MAD) | Experimental | Drug: Exl-111 (MAD)Healthy participants receive Exl-111 at 3 ascending dose levels administered every 4 weeks (Q4W) for a total of 4 doses |
| Placebo | Experimental | Drug: PlaceboParticipants receive placebo injections matched in appearance and schedule to Exl-111: a single SC dose in Part A (SAD) or SC doses Q4W x4 in Part B (MAD), according to their assigned cohort. |
| Comparator | Experimental | Drug: Omalizumab(MAD) Healthy participants receive omalizumab injections every 4 weeks (Q4W) for a total of 4 doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, male and female participants 18-55 years of age at Screening
- Body weight ≥45 kg and ≤120 kg and body mass index (BMI) 18 to ≤32 kg/m2 at Screening and Day -1
- Serum IgE ≥30 IU/mL and ≤300 IU/mL at Screening
- Nonsmoker and must not have used any tobacco products within 2 months prior to Screening. Participants who smoke ≤2 cigarettes or equivalent (e.g., cigars, vaping, nicotine patches) per week can be included in the trial at the discretion of the PI/delegate
- Positive skin prick test at Screening (Part B MAD Cohorts only) to common aeroallergens
Key exclusion criteria (29 listed)
- Received Exl-111 in a prior cohort in this trial
- Prior receipt of any anti-IgE therapy
- Use of any medication, including any prescription, over-the-counter, or other supplements, within 5 days prior to dosing, extending to 30 days after last dose of trial intervention, with the exception of those approved by the PI and Sponsor or Sponsor representative.
- Receipt of any small molecule investigational agent or trial intervention in a clinical trial within 30 days or 5 half-lives (whichever is longer) prior to Day 1
- Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or mAbs) within 3 months or 5 half-lives (whichever is longer) prior to Screening
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 |
|---|---|---|
| Exl-111 (SAD)Exl-111 is administered by subcutaneous injection in a single dose. | Drug | Exl-111 (SAD) |
| Exl-111 (MAD)Exl-111 is administered by subcutaneous injection in ascending dose levels. | Drug | Exl-111 (MAD) |
| PlaceboA placebo matched in appearance and route of administration to Exl-111 is given by subcutaneous injection | Drug | Placebo |
| OmalizumabOmalizumab is administered by subcutaneous injection | Drug | Comparator |
Primary outcome
Incidence and severity of treatment-emergent adverse events and serious adverse events for Part A and Part B
Time frame: From first dose through Day 196.
This is to evaluate the safety and tolerability of single and multiple dose administration of Exl-111 in healthy participants
9 secondary outcomes
Pharmacokinetic assessment of maximum observed plasma concentration (Cmax) of Exl-111
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment of Time to Maximum Concentration (Tmax) of Exl-111
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment apparent Terminal Half-life (t1/2) of Exl-111
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment observed volume of distribution associated with the terminal slope following administration of Exl-111. ( VZO)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment area under the curve (AUC) from the time of dosing to the last measurable concentration of Exl-111. (AUCLST)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the area under the curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration of Exl-111. (AUCIFO)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the area under the curve (AUC) extrapolated to t from dosing time, based on tau of Exl-111. (AUCT)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the maximum concentration occurring at Tmax, divided by the dose of Exl-111. (CMAXD)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the area under the curve (AUC) for the defined interval between doses (TAU) divided by the dose of Exl-111. (AUCTAUD)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exl-111 (SAD), Exl-111 (MAD) and Omalizumab in people with Allergic Disease, run by Excellergy Inc. at 2 sites in 2 countries.
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 6 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, New Zealand. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reza Pishva (+61731376258, reza.pishva@novotech-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events and serious adverse events for Part A and Part B (time frame: From first dose through Day 196.). 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 22 Sep 2026.