A First-in-Human, Ascending Dose, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of UKK-0018 in Adults with Peanut Allergy

What this Trial Is About

Researchers are evaluating UKK-0018, a new immunotherapeutic treatment designed to help adults with peanut allergies by training the immune system to tolerate peanut exposure over time. This first-in-human, open-label, multicenter study focuses on adults aged 18 to 55 with a known peanut allergy, assessing the safety, tolerability, and preliminary efficacy of the treatment. The study aims to reduce allergic symptoms and serious reactions following peanut protein exposure by modifying the treatment to lower binding to IgE antibodies. Participants will receive repeated doses of UKK-0018 through injections during the intervention period. The study includes an initial screening period, followed by the intervention period where dose levels and regimens are evaluated. There is a possibility of an optional dose expansion cohort based on emerging data. After treatment, participants enter a follow-up period to monitor long-term effects and safety. During the study, participants will be monitored closely for adverse reactions, including local and systemic effects within the first week after each injection, as well as any unsolicited or serious adverse events over several weeks. Researchers will assess the treatment's impact on immune response and biomarkers up to 30 weeks after the first injection. Safety checks, questionnaires, and clinical evaluations will be conducted throughout, with the total study duration spanning from screening through follow-up assessments.

UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies