A Phase 1 interventional study of IGNX001 and Placebo in Peanut Allergy, sponsored by IgGenix Australia Pty Ltd. Completed at 4 sites in Australia. Open to participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by IgGenix Australia Pty Ltd · Phase 1, Interventional, and Treatment
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.
152 studies on the registry are indexed under Peanut Hypersensitivity; 29 are open to participants now.
This study's enrollment of 32 is below the median of 50 across 117 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →This is the only study on the registry with IgGenix Australia Pty Ltd as lead sponsor.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Participants will receive IGNX001 given as a single subcutaneous dose on Day 1.
Drug: IGNX001
Participants will receive IGNX001 placebo given as a single subcutaneous dose on Day 1.
Drug: Placebo
IGNX001 given as a single subcutaneous dose on Day 1.
Placebo to IGNX001 given as a single subcutaneous dose on Day 1.
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.
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).
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.
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).
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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
Concentration of IGNX001 in the Plasma
Plasma concentrations of IGNX001 will be measured by a specific and validated immunoassay.
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)
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.
Time frame: 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
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)
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
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)
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.
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
The detection and characterization of antibodies to IGNX001 will be performed using a validated assay method under the supervision of the Sponsor.
Time frame: Assessed at Day 1, Day 15, Day 29, Day 57 and 85 (up to 13 weeks).
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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