Safety of MOON101 for the Treatment of Peanut Allergy
ConditionPeanut Allergy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-55
SponsorMoonlight Therapeutics, Inc.
About this trial
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
Qualifiers
Participant and/or parent/guardian must understand and provide written informed consent and assent.
Group 1: Adults; ages 18-55 years
Group 2: Adolescents; ages 12-17 years
Group 3: Children; ages 4-11 years
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Dose A
- Dose B
- Dose C
- Dose D
- Dose E
- Placebo
Treatment groups
40 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Moonlight Therapeutics, Inc.
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov