The MOON101 stamp is like a patch that is applied to your arm except you only apply it for a few minutes and then remove it. The stamp is coated with peanut allergen and delivers the allergen to the desired location in the skin within a few minutes, so you don’t have to wear the stamp for a long time.  

You must be someone with a medical history of peanut allergy and between the ages of 4-55 years old. There are also other requirements that must be met. Some of these requirements can be found at this link and the clinic will determine if you have met the requirements during the screening process.  

1. Little Rock, Arkansas: Arkansas Children's Research Institute 

2. Atlanta, Georgia: Children's Healthcare of Atlanta 

3. Ann Arbor, Michigan: University of Michigan 

4. Chapel Hill, North Carolina: University of North Carolina Chapel Hill 

5. Overland Park, Kansas: Dr. Vince Clinical Research  

You can contact the people below so they can connect you to a clinical site that can formally evaluate you.  

• Moonlight Project Manager 919-600-1819, michelle.widmann@moonlighttx.com 

• DVCR Project Manager 864-238-7631, sroman@drvince.com 

The goal of this trial is to determine the safety of MOON101 in adults and children who have a peanut allergy. All participants will receive both active MOON101 (peanut allergen) and placebo (no peanut allergen). It is an open label trial, which means everyone will know what they are getting (the dose of the drug or placebo). One of the main goals will be to determine the maximum tolerated dose of MOON101 for each participant.  

There is no known direct medical benefit to you. Your participation in this study will help figure out the safety of MOON101.  It is predicted that the results of this study will help investigators plan future studies. These future studies will also evaluate the efficacy of MOON101 and you may have a chance to participate in those studies if you qualify for them.  

The total length of time for treatment on this study is about 29 days. Study follow-up will occur for about 14 days after completion of study treatment. The maximum time that you may be in the study is about 73 days (around 2 and a half months). There are 7 in clinic visits (screening, 5 treatment visits and a follow up visit) and 6 follow up phone calls. 

You will receive payment for your time and travel associated with being in this study if you qualify and decide to participate in the research study, follow all study requirements and clinical research site rules, and complete all required study visits.  The amount of compensation you may receive varies from site to site. Your site can provide more information about compensation before you start the study.  

While we cannot completely eliminate risks in a clinical trial, we have coordinated with experts to reduce them as much as possible. The Investigational New Drug (IND) for MOON101 has been reviewed by  FDA, meaning that we can start clinical trials. This is the first study where MOON101 will be used in humans. The trial is supported by the National Institutes of Health (NIH) and has been reviewed extensively by doctors in charge of the trial at each site. Prior to the study being initiated, the study was also reviewed and approved by central and local institutional review boards (IRBs).  

You may feel a small scratch or sting during the application and/or removal of placebo and MOON101. There may be allergic reactions (locally and/or systemically) and side effects from both the treatment and some of the study assessments. The clinic will watch for allergic reactions and side effects during study treatment. The clinic will do what they can to relieve them. Allergic reactions and side effects can be serious. There may be other side effects that we don’t know about yet. Before you enroll in the trial you will have a chance to discuss these and other potential risks with a medical professional at the clinic.  

Please contact our clinical project manager, Michelle Widmann, at michelle.widmann@moonlighttx.com.