Safety Evaluation of MOON101 Microneedle Treatment for Peanut Allergy in Children, Adolescents, and Adults

What this Trial Is About

Researchers are evaluating the safety of MOON101, a microneedle treatment for peanut allergy, in an open-label, first-in-human study involving adults, adolescents, and children. The study aims to assess the frequency of treatment emergent adverse events and determine the highest dose each participant can tolerate without dose-limiting symptoms. Approximately 40 participants will be enrolled sequentially in three groups based on age to carefully monitor safety across populations. Participants will receive escalating single doses of MOON101 coated with peanut extract and matching placebo applied to the arms using microneedle stamps. Each participant will undergo up to five treatment visits spaced one week apart, receiving both placebo and active doses at each visit. Following the treatment visits, participants will have follow-up phone calls and one in-clinic follow-up visit to monitor their response and safety. Dose escalation and group enrollment are guided by safety reviews conducted by an independent monitoring board. During the study, participants will be assessed for adverse events and reactions at each visit and follow-up. The study team will collect data on application site reactions and serious adverse events throughout the trial. Participants will be involved for about 73 days, including screening, treatment, follow-up phone calls after dosing, and an in-clinic visit to review safety. The main outcome measured is the occurrence of adverse events from baseline through study exit to evaluate the safety profile of MOON101.

Safety of MOON101 for the Treatment of Peanut Allergy