Safety of MOON101 for the Treatment of Peanut Allergy

The goal of this open-label, single escalating dose study in 3 sequential groups: adults, adolescents, and children with peanut allergy is to assess the safety of MOON101. The main question it aims to answer is: 1. the incidence and frequency of all treatment emergent adverse events (TEAEs) from baseline through study exit. 2. to determine the highest tolerated dose for each participant, as defined by the highest MOON101 dose level administered which did not cause a dose-limiting symptom (DLS). The study will compare MOON101 and placebo. All participants will receive both active MOON101 (peanut allergen) and placebo (no peanut allergen).

NCT Number	NCT07580898
Lead Sponsor	Moonlight Therapeutics, Inc. Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions	Peanut Allergy
Enrollment	40 participants
Start Date	2026-06-29
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-14