Safety of MOON101 for the Treatment of Peanut Allergy

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Peanut Allergy

In brief

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 facts

Study ID

NCT07580898

Run by

Moonlight Therapeutics, Inc.

People needed

40

Starts

2026-06-29

Expected to finish

2027-12-31

Last updated by the study team

2026-07-14

Who can join

Age: 4 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant and/or parent/guardian must understand and provide written informed consent and assent.
• Aged 4 to 55 years per applicable enrolling group below of any sex/race/ethnicity at informed consent and assent (if applicable) form signature:
• Group 1: Adults; ages 18-55 years
• Group 2: Adolescents; ages 12-17 years
• Group 3: Children; ages 4-11 years
• A physician-confirmed medical history of peanut allergy within minutes to 2 hours of ingesting peanut.
• A peanut SPT with mean wheal diameter as defined by age.

You may not qualify if…

• Laboratory evidence of liver or renal disease.
• Poorly controlled or severe asthma/wheezing
• Previous use of any form of peanut allergen immunotherapy within the 6 months prior to Screening.
• 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.
• Current use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), or calcium channel blockers.
• 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.
• Unable to temporarily discontinue antihistamines (5 half-lives of the antihistamine) prior to SPT.
• Unable to discontinue topical steroids to the testing application site for 24 hours prior to testing.
• Other inclusion/exclusion criteria apply.

Where it is running

• Arkansas Children's Research Institute — Little Rock, Arkansas, United States (enrolling)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Dr. Vince Clinical Research — Overland Park, Kansas, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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