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RECRUITING
NCT07580898
PHASE1

Safety of MOON101 for the Treatment of Peanut Allergy

Sponsor: Moonlight Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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).

Key Details

Gender

All

Age Range

4 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-06-05

Completion Date

2027-12-31

Last Updated

2026-06-30

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Dose A

MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).

COMBINATION_PRODUCT

Dose B

MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).

COMBINATION_PRODUCT

Dose C

MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).

COMBINATION_PRODUCT

Dose D

MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).

COMBINATION_PRODUCT

Dose E

MOON101-100 is two microneedle stamps (a square stainless steel array) coated with 50 ug of peanut extract (active drug) each. Two stamps are used to administer a 100ug dose of peanut extract in Dose E.

COMBINATION_PRODUCT

Placebo

MOON101-0 is a microneedle stamp (a square stainless steel array) coated with 0 ug of peanut extract (active drug). There is no peanut extract on the MOON101-0 stamp.

Locations (5)

Arkansas Children's Research Institute

Little Rock, Arkansas, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Dr. Vince Clinical Research

Overland Park, Kansas, United States

University of Michigan

Ann Arbor, Michigan, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States