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

IgGenix

Status and phase: Enrolling; Phase 1

Conditions: Peanut Allergy

Treatments: Drug: Placebo; Drug: IGNX001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06331728

IGNX-T1

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 15 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

IGNX001

Experimental group

Description:

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

Treatment:

Drug: IGNX001

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo