RecruitingPhase 1NCT07580898

Safety of MOON101 for the Treatment of Peanut Allergy

Sponsor

Moonlight Therapeutics, Inc.

Enrollment

40 participants

Start Date

Jun 5, 2026

Study Type

INTERVENTIONAL

Conditions

Peanut allergy

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

Min Age: 4 YearsMax Age: 55 Years

Inclusion Criteria7

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.

Exclusion Criteria8

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.

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Interventions

COMBINATION_PRODUCTDose A

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

COMBINATION_PRODUCTDose B

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

COMBINATION_PRODUCTDose C

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

COMBINATION_PRODUCTDose D

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

COMBINATION_PRODUCTDose 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_PRODUCTPlacebo

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.