Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001

NCT06331728 | Completed Phase 1 DMC

• 1 other identifier: IGNX-T1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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

  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.

  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.

  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).

  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

  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)

  Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).

• Peak Serum Concentration (Cmax)

  Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).

• Time to Peak Serum Concentration (Tmax)

  Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, Day 71 and 85 (up to 13 weeks).

• Elimination Half-life (t1/2)

  Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).

Study Arms (2)

IGNX001

EXPERIMENTAL

Participants will receive IGNX001 given as a single subcutaneous dose on Day 1.

Drug: IGNX001

Placebo

PLACEBO COMPARATOR

Participants will receive IGNX001 placebo given as a single subcutaneous dose on Day 1.

Drug: Placebo

Interventions

IGNX001 DRUG

IGNX001 given as a single subcutaneous dose on Day 1.

IGNX001

Placebo DRUG

Placebo to IGNX001 given as a single subcutaneous dose on Day 1.

Placebo

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IgGenix Australia Pty Ltd: lead

Study Sites (4)

St Vincent's Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Monash Health, Sleep, Allergy, and Immunology

Clayton, Victoria, 3168, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: With the exception of the single sentinel participants for each cohort who will be single blinded (participant blinded), the study will be designed as a double-blind study thus the Investigator, site staff (other than pharmacists), sponsor, sponsors delegates (if applicable) and participants are all blinded to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, single ascending dose study with single blind sentinel period

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 26, 2024
• Study Start: September 1, 2024
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

AU (4)