Study Details

Open

Safety of MOON101 for the Treatment of Peanut Allergy

This study is being done to see if treating adults, adolescents, and children who have peanut allergy with an experimental treatment, called MOON101, is safe. This experimental treatment will expose you to peanut allergen in your skin using a stamp. The purpose of this study is to: -Find out if MOON101 is safe to use. -Know what discomfort you feel when the MOON101 stamp is applied on your skin. -Find a safe dose to use in future studies.

Age & Gender

4 years ~ 55 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide), South Carolina, Virginia

What will be asked of you

For the Treatment Part of the Study: At each treatment visit, a placebo stamp will be applied first. It will be applied for 3 minutes using an applicator to the inside of your right forearm. The MOON101 (peanut stamp) will be applied for 3 minutes after the placebo stamp. At each treatment visit, after you receive the placebo and MOON101, study staff will observe your skin for 2 hours. Each treatment visit has escalating doses of MOON101. Other Parts of the Study: -Answer questions about your health and allergies -Have skin prick testing for allergies -Vital signs measurements -Breathing tests -Pregnancy tests for women of childbearing potential -Blood draws at first and last clinic visits -Physical exams as standard health check -Keep daily diary to monitor your stamp site on your arms -Answer Questionnaires

Incentives

Up to $1,000, Parking Validation

In-person visits:
7

Phone or online visits:
6

Total length of participation:
The maximum time you would be in the study is 2 and a half months.

Looking for Specific Volunteers

Able to participate:

Peanut Allergy
Willing to be trained on epinephrine auto-injector
Negative serum/urine pregnancy
Labs and Skin Testing to Peanut per Protocol (Performed at Screening)
Ages 4-55 Years

Not eligible if:

Currently Pregnant, Lactating, Breastfeeding, or planning to become pregnant during the study
Clinically significant medical history or abnormal labs in opinion of investigator
Previous use of any biologic therapies such as omalizumab, dupilumab, benralizumab, reslizumab, tezepelumab, or any other immunomodulatory (not including stable AIT)
Participation in any interventional study for the treatment of food allergy (including peanut allergy) in the past 6 months prior to Screening
History of EoE, HIV, HBV, HCV, chronic lung disease

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Edwin Kim
Pediatrics - Allergy Immunology and Rheumatology

Study Type

Clinical or Medical
Interventional

Study Topics

Allergy

IRB Number

25-1236