Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Dose AExperimental treatment 1 intervention
Group B: Dose BExperimental treatment 1 intervention
Group C: Dose CExperimental treatment 1 intervention
Group D: Dose DExperimental treatment 1 intervention
Group E: Dose EExperimental treatment 1 intervention
Group F: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment Emergent Adverse Events (TEAEs)

Incidence and frequency of all TEAEs

Time frame
baseline (Day 1) through study exit (Day 45)

Secondary outcomes

1

TEAEs excluding application site reactions (ASRs)

Incidence and frequency of all TEAEs, excluding application site reactions (ASRs)

Time frame
baseline (Day 1) through study exit (Day 45)
2

Serious Adverse Events (SAEs)

Incidence and frequency of SAEs

Time frame
baseline (Day 1) through study exit (Day 45)
3

Adverse Events (AEs)

Incidence and frequency of treatment-related or possibly related AEs

Time frame
baseline (Day 1) through study exit (Day 45)
4

Application Site Reactions (ASRs)

Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.

Time frame
Visit 2 (Day 1)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Moonlight Therapeutics, Inc.

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov
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