Safety of MOON101 for the Treatment of Peanut Allergy

NCT07580898 · tracked via the Priya Life Science USA tracker

Sponsor

Moonlight Therapeutics, Inc.

Phase

Phase 1

Started

2026-06-29

Last updated

2026-07-14

Condition(s) studied

Peanut Allergy

Investigational drug(s) / intervention(s)

Dose ADose BDose CDose DDose EPlacebo

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.

Study 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).

Eligibility

Sex

ALL

Min age

4 Years

Max age

55 Years

Healthy volunteers

Inclusion Criteria: 1. Participant and/or parent/guardian must understand and provide written informed consent and assent. 2. Aged 4 to 55 years per applicable enrolling group below of any sex/race/ethnicity at informed consent and assent (if applicable) form signature: 1. Group 1: Adults; ages 18-55 years 2. Group 2: Adolescents; ages 12-17 years 3. Group 3: Children; ages 4-11 years 3. A physician-confirmed medical history of peanut allergy within minutes to 2 hours of ingesting peanut. 4. A peanut SPT with mean wheal diameter as defined by age. Exclusion Criteria: 1. Laboratory evidence of liver or renal disease. 2. Poorly controlled or severe asthma/wheezing 3. Previous use of any form of peanut allergen immunotherapy within the 6 months prior to Screening. 4. Previous use of any biologic therapies such as omalizumab, dupilumab, benralizumab, reslizumab, tezepelumab, or any other immunomodulatory or immunosuppressive therapy (not including corticosteroids) within the 6 months prior to Screening. 5. Current use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), or calcium channel blockers. 6. Treatment with a burst of oral, intramuscular (IM), intra-articular (IA), or intravenous (IV) steroids of more than two days within 30 days of Screening. 7. Unable to temporarily discontinue antihistamines (5 half-lives of the antihistamine) prior to SPT. 8. Unable to discontinue topical steroids to the testing application site for 24 hours prior to testing. Other inclusion/exclusion criteria apply.

Primary outcome measure(s)

Treatment Emergent Adverse Events (TEAEs) — baseline (Day 1) through study exit (Day 45)
Incidence and frequency of all TEAEs

Trial sites (5)

Facility	City	Region	Status
Arkansas Children's Research Institute	Little Rock	Arkansas	Recruiting
Children's Healthcare of Atlanta	Atlanta	Georgia	Recruiting
Dr. Vince Clinical Research	Overland Park	Kansas	Recruiting
University of Michigan	Ann Arbor	Michigan	Recruiting
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	Recruiting

Other trials for the same condition

Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects Active, not recruiting

A 52-week Study of Remibrutinib in IgE-mediated Food Allergy Recruiting

Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) Active, not recruiting

A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy Active, not recruiting

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07580898 on ClinicalTrials.gov ↗ ← All trials in the USA