Peanut AllergyPhase 1NCT06331728
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001
A Phase 1 study testing IGNX001 in people with Peanut Allergy, run by IgGenix Australia Pty Ltd at 4 sites in Australia.
Trial summary
The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- IGNX001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesAustralia
- Study dates
- 1 Sep 2024to 6 Nov 2025
- 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of physician-diagnosed peanut allergy with clinical reaction to peanut within 2 hours of exposure to peanut or peanut-containing food (within the last 15 years).
- Peanut specific IgE level ≥ 1 kUA/L.
- Positive peanut SPT with wheal diameter ≥ 5 mm.
Who cannot join
- History of severe or life-threatening anaphylaxis requiring intubation or admission to intensive care unit within 1 year prior to Screening.
- Current, or within the past year, treatment with food allergen immunotherapy or participation in a food allergy immunotherapy study.
- Current treatment with aeroallergen immunotherapy, except if on stable monthly maintenance SC aeroallergen immunotherapy.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Monash Health, Sleep, Allergy, and Immunology
Clayton, Victoria, 3168
St Vincent's Sydney
Darlinghurst, New South Wales, 2010
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Royal Melbourne Hospital
Parkville, Victoria, 3050
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study With Single Blind Sentinel Period to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IGNX001 in Peanut-Allergic Participants
The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents.
- Conditions
- Peanut Allergy
- Being tested
- IGNX001, Placebo
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGNX001Drug
IGNX001 given as a single subcutaneous dose on Day 1.
PlaceboDrug
Placebo to IGNX001 given as a single subcutaneous dose on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| IGNX001 | Experimental | Participants will receive IGNX001 given as a single subcutaneous dose on Day 1. Receives: Drug: IGNX001 |
| Placebo | Placebo comparator | Participants will receive IGNX001 placebo given as a single subcutaneous dose on Day 1. Receives: Drug: Placebo |
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
Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. All adverse events will be captured and assessed.
Measured: From time of dose until Exit Visit/Early Termination Visit or until AE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).
Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
A serious adverse events is an adverse event that meets the criteria of being serious as determined by the Investigator. Suspected unexpected serious adverse reactions is an event assessed as serious, related to study product, and unexpected, which are subject to expedited reporting to regulatory authorities and study Investigators.
Measured: From consent until Exit Visit/Early Termination Visit or until SAE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).
Number of Participants with Clinically significant Changes from Baseline - Hematology
The following list of attributes will be assessed: Hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes (white blood cells), differentials (counts): neutrophils, basophils, eosinophils, lymphocytes, and monocytes
Measured: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
Number of Participants with Clinically Significant Changes from Baseline - Chemistry
The following list of attributes will be assessed: Aspartate aminotransferase, alanine aminotransferase, total and conjugated bilirubin, alkaline phosphatase, gamma-glutamyl-transferase, creatine phosphokinase, albumin, creatinine, blood urea nitrogen, total protein, sodium, chloride, calcium, phosphate, potassium, triglycerides, total cholesterol, glucose.
Measured: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
Number of Participants with Clinically Significant Changes from Baseline - 12-lead ECGs for HR, PR, QRS, QT, RR and QTcF, and information on T- and U-waves
All ECGs will be obtained in supine position following a 10-minute rest. Any clinically significant ECG abnormalities will be captured and reported.
Measured: Assessed at Screening, Days 1, 15, and 85 (up to 25 weeks).
Number of Participants with Clinically Significant Changes from Baseline - Physical Examinations
Complete physical examinations include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
Body weight (kilogram) and height (meter) will be obtained with the participant's shoes and jacket or coat removed. Body mass index is calculated by dividing the participant's body weight in kilograms by the participant's height in meters, squared (kg/m2).
Measured: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
Secondary outcomes (6)
Concentration of IGNX001 in the Plasma
Plasma concentrations of IGNX001 will be measured by a specific and validated immunoassay.
Measured: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Measurement of Area under the Plasma/Serum Concentration Curve (AUC)
PK parameters will be computed using non-compartmental analysis (NCA) using the software WinNonlin (Certara, Inc. Princeton, New Jersey). Actual times for drug administration and blood sampling will be used to compute PK parameters.
- AUClast - Area under the concentration-time curve from time zero to the time point of the last reportable concentration (Cplast).
- AUCtotal - Area under the concentration-time curve from time zero to infinity, computed as AUCtotal = AUClast + Cplast/lambda where lambda is the slope of the regression curve used to compute half-life.
- AUC extrapolated - the percent of AUCtotal extrapolated beyond the last reportable concentration (Cplast). AUC extrapolated = 100 x (Cplast/lambda)/AUCtotal.
- AUCx-y - Partial area under the concentration-time curve from time x to time y. More than 1 partial AUC will be computed as feasible.
Measured: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Peak Serum Concentration (Cmax)
PK parameters will be computed using non-compartmental analysis (NCA) using the software WinNonlin (Certara, Inc. Princeton, New Jersey). Actual times for drug administration and blood sampling will be used to compute PK parameters.
Cmax - Peak concentration
Measured: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Time to Peak Serum Concentration (Tmax)
PK parameters will be computed using non-compartmental analysis (NCA) using the software WinNonlin (Certara, Inc. Princeton, New Jersey). Actual times for drug administration and blood sampling will be used to compute PK parameters.
Tmax - Time of Cmax
Measured: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, Day 71 and 85 (up to 13 weeks).
Elimination Half-life (t1/2)
PK parameters will be computed using non-compartmental analysis (NCA) using the software WinNonlin (Certara, Inc. Princeton, New Jersey). Actual times for drug administration and blood sampling will be used to compute PK parameters.
Half-life for each phase of decline in concentrations - Computed from the ln-linear slope (lambda) of the regression on the terminal phase of the concentration-time curve. Half-life = ln(2)/lambda. Rules for acceptance of half-life to be based on robustness of the correlation coefficient for the ln-linear regression to be defined in the SAP.
Measured: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Changes Over Time to Anti-drug Antibodies
The detection and characterization of antibodies to IGNX001 will be performed using a validated assay method under the supervision of the Sponsor.
Measured: Assessed at Day 1, Day 15, Day 29, Day 57 and 85 (up to 13 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Sep 2024
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies 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
- Randomized, double-blind, placebo-controlled, single ascending dose study with single blind sentinel period
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- IgGenix Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331728
- Sponsor's protocol ID
- IGNX-T1
- Status last verified
- Nov 2025
- First submitted
- 12 Mar 2024
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study With Single Blind Sentinel Period to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IGNX001 in Peanut-Allergic Participants
- ClinicalTrials.gov ID
- NCT06331728
- Acronym / sponsor ID
- IGNX-T1
- Conditions
- Peanut Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- IgGenix Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 26 Mar 2024 (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.
The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, single ascending dose study with single blind sentinel period
| Arm | Type | Receives |
|---|---|---|
| IGNX001 | Experimental | Drug: IGNX001Participants will receive IGNX001 given as a single subcutaneous dose on Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive IGNX001 placebo given as a single subcutaneous dose on Day 1. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- History of physician-diagnosed peanut allergy with clinical reaction to peanut within 2 hours of exposure to peanut or peanut-containing food (within the last 15 years).
- Peanut specific IgE level ≥ 1 kUA/L.
- Positive peanut SPT with wheal diameter ≥ 5 mm.
Key exclusion criteria (3 listed)
- History of severe or life-threatening anaphylaxis requiring intubation or admission to intensive care unit within 1 year prior to Screening.
- Current, or within the past year, treatment with food allergen immunotherapy or participation in a food allergy immunotherapy study.
- Current treatment with aeroallergen immunotherapy, except if on stable monthly maintenance SC aeroallergen immunotherapy.
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 |
|---|---|---|
| IGNX001IGNX001 given as a single subcutaneous dose on Day 1. | Drug | IGNX001 |
| PlaceboPlacebo to IGNX001 given as a single subcutaneous dose on Day 1. | Drug | Placebo |
Primary outcome
Incidence and Severity of Treatment Emergent Adverse Events
Time frame: From time of dose until Exit Visit/Early Termination Visit or until AE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).
Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. All adverse events will be captured and assessed.
Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
Time frame: From consent until Exit Visit/Early Termination Visit or until SAE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).
A serious adverse events is an adverse event that meets the criteria of being serious as determined by the Investigator. Suspected unexpected serious adverse reactions is an event assessed as serious, related to study product, and unexpected, which are subject to expedited reporting to regulatory authorities and study Investigators.
Number of Participants with Clinically significant Changes from Baseline - Hematology
Time frame: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
The following list of attributes will be assessed: Hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes (white blood cells), differentials (counts): neutrophils, basophils, eosinophils, lymphocytes, and monocytes
Number of Participants with Clinically Significant Changes from Baseline - Chemistry
Time frame: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
The following list of attributes will be assessed: Aspartate aminotransferase, alanine aminotransferase, total and conjugated bilirubin, alkaline phosphatase, gamma-glutamyl-transferase, creatine phosphokinase, albumin, creatinine, blood urea nitrogen, total protein, sodium, chloride, calcium, phosphate, potassium, triglycerides, total cholesterol, glucose.
Number of Participants with Clinically Significant Changes from Baseline - 12-lead ECGs for HR, PR, QRS, QT, RR and QTcF, and information on T- and U-waves
Time frame: Assessed at Screening, Days 1, 15, and 85 (up to 25 weeks).
All ECGs will be obtained in supine position following a 10-minute rest. Any clinically significant ECG abnormalities will be captured and reported.
Number of Participants with Clinically Significant Changes from Baseline - Physical Examinations
Time frame: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
Complete physical examinations include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes. Body weight (kilogram) and height (meter) will be obtained with the participant's shoes and jacket or coat removed. Body mass index is calculated by dividing the participant's body weight in kilograms by the participant's height in meters, squared (kg/m2).
6 secondary outcomes
Concentration of IGNX001 in the Plasma
Time frame: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Measurement of Area under the Plasma/Serum Concentration Curve (AUC)
Time frame: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Peak Serum Concentration (Cmax)
Time frame: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Time to Peak Serum Concentration (Tmax)
Time frame: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, Day 71 and 85 (up to 13 weeks).
Elimination Half-life (t1/2)
Time frame: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
Changes Over Time to Anti-drug Antibodies
Time frame: Assessed at Day 1, Day 15, Day 29, Day 57 and 85 (up to 13 weeks).
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 14 Nov 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IGNX001 in people with Peanut Allergy, run by IgGenix Australia Pty Ltd at 4 sites 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 3 inclusion and 3 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 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 and Severity of Treatment Emergent Adverse Events (time frame: From time of dose until Exit Visit/Early Termination Visit or until AE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).). The study lists 6 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 14 Nov 2025.