Safety of MOON101 for the Treatment of Peanut Allergy

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).

Conditions

• Peanut Allergy

Interventions

COMBINATION_PRODUCT

Dose A

MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).

COMBINATION_PRODUCT

Dose B

MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).

COMBINATION_PRODUCT

Dose C

MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).

COMBINATION_PRODUCT

Dose D

MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).

COMBINATION_PRODUCT

Dose E

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.

COMBINATION_PRODUCT

Placebo

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Moonlight Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Samir Patel, PhD · Moonlight Therapeutics, Inc.

• Brian P Vickery, MD · Professor of Pediatrics, Emory University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

4 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-07

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations