NCT07580898 Safety of MOON101 for the Treatment of Peanut Allergy
| NCT ID | NCT07580898 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Moonlight Therapeutics, Inc. |
| Condition | Peanut Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-06-29 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-06-29 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Samir Patel, PhD
PRINCIPAL INVESTIGATOR
Moonlight Therapeutics, Inc.
Frequently Asked Questions
Who can join the NCT07580898 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 55 Years, studying Peanut Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07580898 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07580898 currently recruiting?
Yes, NCT07580898 is actively recruiting participants. Contact the research team at trials@moonlighttx.com for enrollment information.
Where is the NCT07580898 trial being conducted?
This trial is being conducted at Little Rock, United States, Atlanta, United States, Overland Park, United States, Ann Arbor, United States and 1 additional location.
Who is sponsoring the NCT07580898 clinical trial?
NCT07580898 is sponsored by Moonlight Therapeutics, Inc.. The principal investigator is Samir Patel, PhD at Moonlight Therapeutics, Inc.. The trial plans to enroll 40 participants.