Phase 12 Study of ENP-501 for Treatment of Peanut Allergy and Non-Allergic Participants Ages 14 to 50

What this Trial Is About

Researchers are evaluating the safety and clinical activity of ENP-501 in people aged 14 to 50 years, including those who have a known peanut allergy and those who are not allergic to peanuts. This Phase 12 study includes healthy participants and aims to understand how ENP-501 might affect allergic reactions to peanut protein, an important concern for individuals with peanut allergy. Participants will receive daily buccal inside the cheek administrations of ENP-501 or a placebo. In Part 1 of the study, this treatment lasts for 6 to 14 weeks, and in Part 2, participants who reach a target dose of 2000 micrograms will continue treatment daily for 52 weeks. The study is randomized and includes dose escalation to assess safety and tolerability. During the study, participants will undergo regular assessments including monitoring for adverse events, changes in physical exams, vital signs, and laboratory tests. They will also complete specialized food challenges to measure their tolerance to peanut protein. The study will track immune responses through blood tests and skin prick tests over periods up to 72 weeks, helping researchers evaluate the treatments impact and safety over time.

Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants