Safety of MOON101 for the Treatment of Peanut Allergy
SURVEYOR
2 other identifiers
interventional
40
1 country
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2026
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2026
CompletedStudy Start
First participant enrolled
May 7, 2026
CompletedFirst Posted
Study publicly available on registry
May 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 14, 2026
May 1, 2026
1.7 years
April 24, 2026
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Emergent Adverse Events (TEAEs)
Incidence and frequency of all TEAEs
baseline (Day 1) through study exit (Day 45)
Secondary Outcomes (10)
TEAEs excluding application site reactions (ASRs)
baseline (Day 1) through study exit (Day 45)
Serious Adverse Events (SAEs)
baseline (Day 1) through study exit (Day 45)
Adverse Events (AEs)
baseline (Day 1) through study exit (Day 45)
Application Site Reactions (ASRs)
Visit 2 (Day 1)
Application Site Reactions (ASRs)
Visit 3 (Day 8 +/-2)
- +5 more secondary outcomes
Study Arms (6)
Dose A
EXPERIMENTAL1ug MOON101 and Placebo stamps
Dose B
EXPERIMENTAL10ug MOON101 and Placebo stamps
Dose C
EXPERIMENTAL25ug MOON101 and Placebo stamps
Dose D
EXPERIMENTAL50ug MOON101 and Placebo stamps
Dose E
EXPERIMENTAL100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp
Placebo
PLACEBO COMPARATORmicroneedle stamp with no peanut extract on it
Interventions
MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).
MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).
MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).
MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).
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.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Dr. Vince Clinical Research
Overland Park, Kansas, 66212, United States
University of Michigan
Ann Arbor, Michigan, 48106, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samir Patel, PhD
Moonlight Therapeutics, Inc.
- STUDY CHAIR
Brian P Vickery, MD
Professor of Pediatrics, Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2026
First Posted
May 12, 2026
Study Start
May 7, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share