[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585861":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":160,"collaborators":24,"id":162,"slug":163,"hasResults":164,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":164,"sex":170,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":24,"studyType":176,"phases":177,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"Epicrispr Biotechnologies, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EPI-321 Cohort 1 Single IV Dose","EXPERIMENTAL","Single IV infusion of a target dose of 2x10\\^13 vg\u002Fkg",[13],"Biological: EPI-321",{"label":15,"type":10,"description":16,"interventionNames":17},"EPI-321 Cohort 2 Single IV Dose","Single IV infusion of a target dose of 4x10\\^13 vg\u002Fkg",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","EPI-321","EPI-321 IV Infusion",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Weston Miller, M.D.","CONTACT","888-562-4123","epic.clinicaltrial@epic-bio.com",[32,54,71,88,105,122,144],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"David Geffen School of Medicine at University of California, Los Angeles","RECRUITING","Los Angeles","California","90095","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-118.24368,34.05223,{"lat":44,"lon":43},[47,51],{"name":48,"role":28,"phone":49,"phoneExt":24,"email":50},"Brenden Roberts","310-825-3264","BrendenRoberts@mednet.ucla.edu",{"name":52,"role":53,"phone":24,"phoneExt":24,"email":24},"Perry Shieh, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":34,"city":56,"state":57,"zip":58,"country":38,"countryCode":39,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Rare Disease Research","Atlanta","Georgia","303329",{"type":41,"coordinates":60},[61,62],-84.38798,33.749,{"lat":62,"lon":61},[65,69],{"name":66,"role":28,"phone":67,"phoneExt":24,"email":68},"Laura Sutton","470-600-9134","laura.sutton@rarediseaseresearch.com",{"name":70,"role":53,"phone":24,"phoneExt":24,"email":24},"Renata Shih, MD",{"facility":72,"status":34,"city":73,"state":74,"zip":75,"country":38,"countryCode":39,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Kennedy Krieger Institute, Center for Genetic Muscle Disorders","Baltimore","Maryland","21205",{"type":41,"coordinates":77},[78,79],-76.61219,39.29038,{"lat":79,"lon":78},[82,86],{"name":83,"role":28,"phone":84,"phoneExt":24,"email":85},"Demaya Starkes","443-923-3832","starkesd@kennedykrieger.org",{"name":87,"role":53,"phone":24,"phoneExt":24,"email":24},"Doris G Leung, MD, PhD",{"facility":89,"status":34,"city":90,"state":91,"zip":92,"country":38,"countryCode":39,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"University of Massachusetts Chan Medical School","Worcester","Massachusetts","01605",{"type":41,"coordinates":94},[95,96],-71.80229,42.26259,{"lat":96,"lon":95},[99,103],{"name":100,"role":28,"phone":101,"phoneExt":24,"email":102},"Catherine Douthwright","508-865-1524","Catherine.Douthwright@umassmed.edu",{"name":24,"role":28,"phone":24,"phoneExt":24,"email":104},"FSHDresearch@umassmed.edu",{"facility":106,"status":34,"city":107,"state":108,"zip":109,"country":38,"countryCode":39,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Utah Program for Inherited Neuromuscular Disorders - University of Utah","Salt Lake City","Utah","84112",{"type":41,"coordinates":111},[112,113],-111.89105,40.76078,{"lat":113,"lon":112},[116,120],{"name":117,"role":28,"phone":118,"phoneExt":24,"email":119},"Ryan Kennington","801-587-0833","ryan.kennington@hsc.utah.edu",{"name":121,"role":53,"phone":24,"phoneExt":24,"email":24},"Russell Butterfield, MD, PhD",{"facility":123,"status":34,"city":124,"state":125,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Royal Alfred Hospital","Sydney","New South Wales","2050","Australia","AU",{"type":41,"coordinates":130},[131,132],151.20732,-33.86785,{"lat":132,"lon":131},[135,139,142],{"name":136,"role":28,"phone":137,"phoneExt":24,"email":138},"Sasan Mortazavi","612 9515 4867","SLHD-RPACMTTrials@health.nsw.gov.au",{"name":140,"role":28,"phone":141,"phoneExt":24,"email":138},"Miles Kenny","612 9515 8453",{"name":143,"role":53,"phone":24,"phoneExt":24,"email":24},"Katrina Anne Morris, BMedSCI, MBBS(Hons), PhD,FRACP",{"facility":145,"status":34,"city":146,"state":24,"zip":147,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Pacific Clinical Research Network","Auckland","0622","New Zealand","NZ",{"type":41,"coordinates":151},[152,153],174.76349,-36.84853,{"lat":153,"lon":152},[156],{"name":157,"role":28,"phone":158,"phoneExt":24,"email":159},"Miriam Rodrigues","64-021896662","mrodrigues@adhb.govt.nz",{"type":161,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100585861","phase-1-a-first-in-human-study-of-epi-321-in-facioscapulohumeral-muscular-dystrophy-100585861",false,"NCT06907875","A First-in-human Study of EPI-321 in Facioscapulohumeral Muscular Dystrophy","A Phase 1\u002F2 Open-label Dose-escalation Study to Evaluate the Safety, Tolerability, and Biological Activity of EPI-321, an AAVrh74-delivered Epigenetic Editing Therapy in Adult FSHD Patients","FSHD","Inclusion Criteria:\n\n* Able and willing to provide informed consent\n* Male or female 18 to 75 years of age\n* Clinical diagnosis of FSHD with genetic Type 1\n* FSHD Ricci clinical severity score 2 to 4 (on 5-point scale)\n* Has adequate liver function\n* Has adequate kidney function\n\nExclusion Criteria:\n\n* Has an anti-AAVrh74 total binding antibody titer \\> 1:400\n* Requires a walker or wheelchair for ambulation\n* Pregnant and\u002For breastfeeding at baseline or is planning to become pregnant during the first 12 months following EPI-321 administration\n* Has FSHD Type 2\n* Has a concurrent or past medical conditions could jeopardize the safety of the participant","ALL","18 Years","75 Years",{"count":174,"type":175},12,"ESTIMATED","INTERVENTIONAL",[178,179],"PHASE1","PHASE2","The goal of this clinical trial is to learn how safe and tolerable EPI-321 is and whether there may be early signs it is working in male or female adult (18 to 75 years) participants with facioscapulohumeral muscular dystrophy (FSHD) Type 1 condition. The main questions it aims to answer are:\n\nHow safe is EPI-321 and how well can people handle it over time? How does EPI-321 interact with its target and does it show early signs of working?\n\nParticipants will receive a single dose of EPI-321 through a vein while being closely watched in a hospital and visit the clinic regularly for tests and checkups for about 5 years after getting EPI-321.",[182],"Facioscapulohumeral Muscular Dystrophy",[182,21,184],"Muscular Dystrophy","2026-04-20",{"date":187,"type":188},"2026-04-22","ACTUAL",{"date":190,"type":188},"2025-05-08",{"date":192,"type":175},"2032-04-30",{"name":5,"class":6},7]