Testing UKK-0018 Injection for Safety and Effectiveness in Adults With Peanut Allergy Ages 18 to 55

What this Trial Is About

Researchers are evaluating UKK-0018, a new investigational immunotherapeutic treatment for adults with peanut allergies. This first-in-human, open-label, multicenter study aims to assess the safety, tolerability, and preliminary effectiveness of UKK-0018 in reducing allergic reactions to peanut proteins. The treatment is designed to retrain the immune system to tolerate peanut exposure and may reduce the risk of serious allergic reactions compared to current standards. Participants will receive UKK-0018 through injections given into the muscle. The study includes a screening period, an intervention period with repeated dosing, and a follow-up period to monitor effects. An optional dose expansion group may be added based on emerging data. The treatment regimens and dose levels are being evaluated to understand the best approach. Participants will undergo safety evaluations including monitoring for local and systemic adverse reactions, medical events, and specific safety concerns for up to 30 weeks after the first injection. Researchers will also assess preliminary efficacy and immune response markers at 28 days after the last treatment and up to 30 weeks. The total study duration includes screening, treatment, and follow-up phases to ensure thorough assessment of UKK-0018.

UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies