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NCT06331728 | RECRUITING | Peanut Allergy

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

IgGenix Australia Pty Ltd

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.

Condition or disease

Peanut Allergy

Intervention/treatment

IGNX001

Placebo

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 32 participants
Masking : QUADRUPLE
Masking Description : 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.
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-09-01
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 15 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • * 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
    • * 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.
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001

Location Details

NCT06331728

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Australia, New South Wales

St Vincent's Sydney

Darlinghurst, New South Wales, Australia, 2010

RECRUITING

Australia, Victoria

Monash Health, Sleep, Allergy, and Immunology

Clayton, Victoria, Australia, 3168

RECRUITING

Australia, Victoria

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

RECRUITING

Australia, Western Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia, 6150