IgGenix Peanut Allergy Vaccine Study – IGNX-T1

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 Adults and Older Adolescents.

ACCELERATE PEANUT

Study Population

Approximately 24 adults and older adolescent participants with peanut allergies will be enrolled sequentially into 3 ascending dose cohorts (150 mg, 300 mg and 600 mg IGNX001).

Eligible subjects must be:

15 to 55 years of age

have a history of physician-diagnosed peanut allergy with a clinical reaction to peanut within 2 hours of exposure to peanut or peanut containing products (within last 15 years)

Peanut specific IgE level ≥ 1 kUA/L.

Positive peanut Skin Prick Test

Subjects with severe asthma, liver or kidney disease, and women who are pregnant or lactating will not be eligible to participate in the study.

Study visits

The study duration is 13 weeks, not including a 90-day Screening period.

Screening visit up to 90 days prior to randomisation, 12 onsite visits over 12 weeks (includes follow up period)

Study Requirements

Medication is taken via nebuliser 4 times/day

Skin Prick Tests, blood tests, ECG

Oral Food challenge (x2) at Screening and at 4 weeks post dose.

Must comply with lifestyle and medications restrictions.

Clinical Trials Registry:

https://clinicaltrials.gov/study/NCT06331728