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

Launched by IGGENIX AUSTRALIA PTY LTD · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IGNX001 for people who are allergic to peanuts. The main goal is to find out if IGNX001 is safe to use and how the body processes it after taking it. The trial is specifically looking for adults and older teens who have been diagnosed with a peanut allergy and have had a reaction to peanuts in the past 15 years. To be eligible, participants need to have certain levels of peanut-specific antibodies in their blood and a positive skin test for peanuts.

If you decide to participate, you'll be randomly assigned to receive either IGNX001 or a placebo (a harmless "dummy" treatment) without knowing which one you got. Throughout the trial, the researchers will monitor your health closely to see how well you tolerate the treatment and whether it has any effects on your peanut allergy. This trial is currently recruiting participants, so if you meet the eligibility criteria and are interested, it could be a chance to contribute to important research that may help improve treatments for peanut allergies in the future.

Gender

ALL

Eligibility 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.