Safety of MOON101 for the Treatment of Peanut Allergy

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Moonlight Therapeutics, Inc.
Study ID
NCT07580898
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Peanut Allergy

Eligibility Criteria

Sex
ALL
Age
4 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Dose A — COMBINATION_PRODUCT
    MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).
  • Dose B — COMBINATION_PRODUCT
    MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).
  • Dose C — COMBINATION_PRODUCT
    MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).
  • Dose D — COMBINATION_PRODUCT
    MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).
  • Dose E — COMBINATION_PRODUCT
    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 — COMBINATION_PRODUCT
    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.

Study Details

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).

Key Dates

Start date
Jun 5, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Arkansas Children's Research InstituteLittle RockArkansas72202
Moonlight Project Manager
[email protected]
919-600-1819
DVCR Project Manager
[email protected]
864-238-7631
Children's Healthcare of AtlantaAtlantaGeorgia30329
Moonlight Project Manager
[email protected]
919-600-1819
DVCR Project Manager
[email protected]
864-238-7631
Dr. Vince Clinical ResearchOverland ParkKansas66212
Moonlight Project Manager
[email protected]
919-600-1819
DVCR Project Manager
[email protected]
864-238-7631
University of MichiganAnn ArborMichigan48106
Moonlight Project Manager
[email protected]
919-600-1819
DVCR Project Manager
[email protected]
864-238-7631
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Moonlight Project Manager
[email protected]
919-600-1819
DVCR Project Manager
[email protected]
864-238-7631

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Research Institute· Little Rock, ARChildren's Healthcare of Atlanta· Atlanta, GADr. Vince Clinical Research· Overland Park, KSUniversity of Michigan· Ann Arbor, MIUniversity of North Carolina at Chapel Hill· Chapel Hill, NC

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