Clinical Research Directory
Browse clinical research sites, groups, and studies.
Safety of MOON101 for the Treatment of Peanut Allergy
Sponsor: Moonlight Therapeutics, Inc.
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
Dose A
MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).
Dose B
MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).
Dose C
MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).
Dose D
MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).
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.
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