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

Last updated: April 1, 2025
Sponsor: IgGenix Australia Pty Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Allergy (Peanut)

Treatment

IGNX001

Placebo

Clinical Study ID

NCT06331728
IGNX-T1
  • Ages 15-55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • History of physician-diagnosed peanut allergy with clinical reaction to peanutwithin 2 hours of exposure to peanut or peanut-containing food (within the last 15years).

  • Peanut specific IgE level ≥ 1 kUA/L.

  • Positive peanut SPT with wheal diameter ≥ 5 mm.

Exclusion

Key Exclusion Criteria:

  • History of severe or life-threatening anaphylaxis requiring intubation or admissionto intensive care unit within 1 year prior to Screening.

  • Current, or within the past year, treatment with food allergen immunotherapy orparticipation in a food allergy immunotherapy study.

  • Current treatment with aeroallergen immunotherapy, except if on stable monthlymaintenance SC aeroallergen immunotherapy.

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: IGNX001
Phase: 1
Study Start date:
September 01, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • St Vincent's Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Monash Health, Sleep, Allergy, and Immunology

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

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