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Peanut allergy patch enters human safety trials

NCT ID NCT07580898

Disease control Sponsor: Moonlight Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 5 times

Summary

This early-stage trial is testing whether a microneedle patch called MOON101, which delivers tiny amounts of peanut protein into the skin, is safe for people with peanut allergies. The study will enroll 40 participants, including adults, teenagers, and children. Each person will receive both the active patch and a placebo patch to compare side effects. The main goal is to check for any harmful reactions and find the highest dose that people can tolerate without serious symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
peanut extract applied via a microneedle stamp
What this could lead to
If safe, this could pave the way for a treatment that reduces peanut allergy reactions.
What could go wrong
This is an early Phase 1 safety study with only 40 people, so it may not lead to an effective treatment. Allergic reactions to the patch itself are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

food allergy Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peanut allergy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Arkansas Children's Research Institute

    RECRUITING

    Little Rock, Arkansas, 72202, United States

    Contact Email: •••••@•••••

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

    Contact Email: •••••@•••••

  • Dr. Vince Clinical Research

    RECRUITING

    Overland Park, Kansas, 66212, United States

    Contact Email: •••••@•••••

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48106, United States

    Contact Email: •••••@•••••

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

    Contact Email: •••••@•••••

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