Recruiting
Phase 1

MOON101

Sponsor:

Moonlight Therapeutics, Inc.

Code:

NCT07580898

Conditions

Peanut Allergy

Eligibility Criteria

Sex: All

Age: 4 - 55

Healthy Volunteers: Not accepted

Interventions

Dose A

Dose B

Dose C

Dose D

Dose E

Study Details

Brief 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).

Conditions

Peanut Allergy

Study ID

NCT07580898

Start date

Jun 29, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose A

1ug MOON101 and Placebo stamps

experimental: Dose B

10ug MOON101 and Placebo stamps

experimental: Dose C

25ug MOON101 and Placebo stamps

experimental: Dose D

50ug MOON101 and Placebo stamps

experimental: Dose E

100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp

placebo comparator: Placebo

microneedle stamp with no peanut extract on it

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.

Primary outcome measure

  • Treatment Emergent Adverse Events (TEAEs) [ Time Frame: baseline (Day 1) through study exit (Day 45) ]

Central Contacts and Locations

Central contacts

Locations

Arkansas Children's Research Institute

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Moonlight Project Manager

919-600-1819trials@moonlighttx.com

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Moonlight Project Manager

919-600-1819trials@moonlighttx.com

Dr. Vince Clinical Research

Recruiting

Overland Park, Kansas, United States, 66212

Contacts

Moonlight Project Manager

919-600-1819trials@moonlighttx.com

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Moonlight Project Manager

919-600-1819trials@moonlighttx.com

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Moonlight Project Manager

919-600-1819trials@moonlighttx.com

More Information

Sponsor

Moonlight Therapeutics, Inc.

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • peanut allergy
  • immunotherapy
  • transdermal
  • microneedle
  • viaskin
  • palforzia
  • pediatric
  • adolescent
  • children
  • patch

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Moonlight Therapeutics, Inc. on 2026-07-14.