[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642457":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":61,"centralContacts":69,"locations":77,"responsibleParty":149,"collaborators":151,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":157,"sex":162,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":45,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":98,"whyStopped":45,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"Moonlight Therapeutics, Inc.","INDUSTRY",[8,14,19,24,29,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose A","EXPERIMENTAL","1ug MOON101 and Placebo stamps",[13],"Combination Product: Dose A",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose B","10ug MOON101 and Placebo stamps",[18],"Combination Product: Dose B",{"label":20,"type":10,"description":21,"interventionNames":22},"Dose C","25ug MOON101 and Placebo stamps",[23],"Combination Product: Dose C",{"label":25,"type":10,"description":26,"interventionNames":27},"Dose D","50ug MOON101 and Placebo stamps",[28],"Combination Product: Dose D",{"label":30,"type":10,"description":31,"interventionNames":32},"Dose E","100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp",[33],"Combination Product: Dose E",{"label":35,"type":36,"description":37,"interventionNames":38},"Placebo","PLACEBO_COMPARATOR","microneedle stamp with no peanut extract on it",[39],"Combination Product: Placebo",[41,46,49,52,55,58],{"type":42,"name":9,"description":43,"armGroupLabels":44,"otherNames":45},"COMBINATION_PRODUCT","MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).",[9],null,{"type":42,"name":15,"description":47,"armGroupLabels":48,"otherNames":45},"MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).",[15],{"type":42,"name":20,"description":50,"armGroupLabels":51,"otherNames":45},"MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).",[20],{"type":42,"name":25,"description":53,"armGroupLabels":54,"otherNames":45},"MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).",[25],{"type":42,"name":30,"description":56,"armGroupLabels":57,"otherNames":45},"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.",[30],{"type":42,"name":35,"description":59,"armGroupLabels":60,"otherNames":45},"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.",[35],[62,65],{"name":63,"affiliation":5,"role":64},"Samir Patel, PhD","PRINCIPAL_INVESTIGATOR",{"name":66,"affiliation":67,"role":68},"Brian P Vickery, MD","Professor of Pediatrics, Emory University","STUDY_CHAIR",[70,75],{"name":71,"role":72,"phone":73,"phoneExt":45,"email":74},"Michelle C Widmann","CONTACT","9196001819","trials@moonlighttx.com",{"name":63,"role":72,"phone":76,"phoneExt":45,"email":74},"404-348-8294",[78,96,109,125,137],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Arkansas Children's Research Institute","NOT_YET_RECRUITING","Little Rock","Arkansas","72202","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-92.28959,34.74648,{"lat":90,"lon":89},[93],{"name":94,"role":72,"phone":95,"phoneExt":45,"email":74},"Moonlight Project Manager","919-600-1819",{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":84,"countryCode":85,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Children's Healthcare of Atlanta","RECRUITING","Atlanta","Georgia","30329",{"type":87,"coordinates":103},[104,105],-84.38798,33.749,{"lat":105,"lon":104},[108],{"name":94,"role":72,"phone":95,"phoneExt":45,"email":74},{"facility":110,"status":98,"city":111,"state":112,"zip":113,"country":84,"countryCode":85,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Dr. Vince Clinical Research","Overland Park","Kansas","66212",{"type":87,"coordinates":115},[116,117],-94.67079,38.98223,{"lat":117,"lon":116},[120,121],{"name":94,"role":72,"phone":95,"phoneExt":45,"email":74},{"name":122,"role":72,"phone":123,"phoneExt":45,"email":124},"DVCR Project Manager","864-238-7631","sroman@drvince.com",{"facility":126,"status":80,"city":127,"state":128,"zip":129,"country":84,"countryCode":85,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"University of Michigan","Ann Arbor","Michigan","48106",{"type":87,"coordinates":131},[132,133],-83.74088,42.27756,{"lat":133,"lon":132},[136],{"name":94,"role":72,"phone":95,"phoneExt":45,"email":74},{"facility":138,"status":98,"city":139,"state":140,"zip":141,"country":84,"countryCode":85,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"type":87,"coordinates":143},[144,145],-79.05584,35.9132,{"lat":145,"lon":144},[148],{"name":94,"role":72,"phone":95,"phoneExt":45,"email":74},{"type":150,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[152],{"name":153,"class":154},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100642457","phase-1-safety-of-moon101-for-the-treatment-of-peanut-allergy-100642457",false,"NCT07580898","Safety of MOON101 for the Treatment of Peanut Allergy","SURVEYOR","Inclusion Criteria:\n\n1. Participant and\u002For parent\u002Fguardian must understand and provide written informed consent and assent.\n2. Aged 4 to 55 years per applicable enrolling group below of any sex\u002Frace\u002Fethnicity at informed consent and assent (if applicable) form signature:\n\n   1. Group 1: Adults; ages 18-55 years\n   2. Group 2: Adolescents; ages 12-17 years\n   3. Group 3: Children; ages 4-11 years\n3. A physician-confirmed medical history of peanut allergy within minutes to 2 hours of ingesting peanut.\n4. A peanut SPT with mean wheal diameter as defined by age.\n\nExclusion Criteria:\n\n1. Laboratory evidence of liver or renal disease.\n2. Poorly controlled or severe asthma\u002Fwheezing\n3. Previous use of any form of peanut allergen immunotherapy within the 6 months prior to Screening.\n4. 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.\n5. Current use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), or calcium channel blockers.\n6. 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.\n7. Unable to temporarily discontinue antihistamines (5 half-lives of the antihistamine) prior to SPT.\n8. Unable to discontinue topical steroids to the testing application site for 24 hours prior to testing.\n\nOther inclusion\u002Fexclusion criteria apply.","ALL","4 Years","55 Years",{"count":166,"type":167},40,"ESTIMATED","INTERVENTIONAL",[170],"PHASE1","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:\n\n1. the incidence and frequency of all treatment emergent adverse events (TEAEs) from baseline through study exit.\n2. 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).\n\nThe study will compare MOON101 and placebo. All participants will receive both active MOON101 (peanut allergen) and placebo (no peanut allergen).",[173],"Peanut Allergy",[175,176,177,178,179,180,181,182,183,184],"peanut allergy","immunotherapy","transdermal","microneedle","viaskin","palforzia","pediatric","adolescent","children","patch","2026-06-29",{"date":187,"type":188},"2026-07-01","ACTUAL",{"date":190,"type":167},"2026-06-05",{"date":192,"type":167},"2027-12-31",{"name":5,"class":6},5]