Actively Recruiting
Safety of MOON101 for the Treatment of Peanut Allergy
Led by Moonlight Therapeutics, Inc. · Updated on 2026-06-02
40
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Moonlight Therapeutics, Inc.
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of MOON101, a new treatment for peanut allergy, in an open-label, single escalating dose study involving three groups: adults, adolescents, and children. The study aims to assess the frequency of treatment-related side effects and determine the highest dose each participant can tolerate without severe symptoms. Both MOON101 and placebo will be given to all participants to compare reactions. The study involves approximately 40 participants divided into three sequential groups: adults (18-55 years), adolescents (12-17 years), and children (4-11 years). Each participant will receive up to five escalating doses of MOON101 or placebo, applied as microneedle stamps coated with increasing amounts of peanut extract. Doses are administered every seven days on the arms, with safety reviews between groups to allow progression. Participants will be involved for about 73 days, including a screening visit, five treatment visits with follow-up phone calls 24 hours after each dose, an in-clinic follow-up visit about a week after the last dose, and a final phone call two weeks later. Researchers will monitor adverse events, application site reactions, and determine the highest dose tolerated. Safety will be overseen throughout by an independent monitoring board to ensure participant well-being.
CONDITIONS
Brief Title
Safety of MOON101 for the Treatment of Peanut Allergy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant and/or parent/guardian must understand and provide written informed consent and assent
- Aged 4 to 55 years, divided into: Adults (18-55 years), Adolescents (12-17 years), and Children (4-11 years)
- Physician-confirmed medical history of peanut allergy with symptoms occurring within minutes to 2 hours after eating peanuts
- Positive peanut skin prick test with mean wheal diameter appropriate for age
You will not qualify if you...
- Laboratory evidence of liver or kidney disease
- Poorly controlled or severe asthma or wheezing
- Use of any peanut allergen immunotherapy within 6 months before screening
- Use of biologic therapies like omalizumab, dupilumab, or other immunomodulatory drugs within 6 months prior to screening
- Current use of oral beta-blockers, ACE inhibitors, ARBs, or calcium channel blockers
- Treatment with oral, intramuscular, intra-articular, or intravenous steroids for more than two days within 30 days before screening
- Unable to temporarily stop antihistamines before skin prick testing
- Unable to stop topical steroids on the test site 24 hours before testing
- Other inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 weeks
Participants receive up to 5 escalating doses of MOON101 and matching placebo applied to the arm, with one dose given every 7 days as tolerated.
5 dosing visits (in-person) with a follow-up phone call 24 hours after each dose
Duration - Approximately 3 weeks
Participants have one in-clinic follow-up visit about 7 days after their last dose, followed by a phone call approximately 14 days after the last dose to monitor safety.
1 in-clinic visit and 1 follow-up phone call
Trial Site Locations
Total: 5 locations
1
Arkansas Children's Research Institute
Little Rock, Arkansas, United States, 72202
Not Yet Recruiting
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Not Yet Recruiting
3
Dr. Vince Clinical Research
Overland Park, Kansas, United States, 66212
Not Yet Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48106
Not Yet Recruiting
5
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
M
Michelle C Widmann
S
Samir Patel, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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