[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585861":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":157,"collaborators":24,"id":159,"slug":24,"hasResults":160,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":160,"sex":166,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":24,"studyType":172,"phases":173,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"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",[32,53,70,87,104,121,142],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"David Geffen School of Medicine at University of California, Los Angeles","RECRUITING","Los Angeles","California","90095","United States",{"type":40,"coordinates":41},"Point",[42,43],-118.24368,34.05223,{"lat":43,"lon":42},[46,50],{"name":47,"role":28,"phone":48,"phoneExt":24,"email":49},"Brenden Roberts","310-825-3264","BrendenRoberts@mednet.ucla.edu",{"name":51,"role":52,"phone":24,"phoneExt":24,"email":24},"Perry Shieh, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":54,"status":34,"city":55,"state":56,"zip":57,"country":38,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Rare Disease Research","Atlanta","Georgia","303329",{"type":40,"coordinates":59},[60,61],-84.38798,33.749,{"lat":61,"lon":60},[64,68],{"name":65,"role":28,"phone":66,"phoneExt":24,"email":67},"Laura Sutton","470-600-9134","laura.sutton@rarediseaseresearch.com",{"name":69,"role":52,"phone":24,"phoneExt":24,"email":24},"Renata Shih, MD",{"facility":71,"status":34,"city":72,"state":73,"zip":74,"country":38,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Kennedy Krieger Institute, Center for Genetic Muscle Disorders","Baltimore","Maryland","21205",{"type":40,"coordinates":76},[77,78],-76.61219,39.29038,{"lat":78,"lon":77},[81,85],{"name":82,"role":28,"phone":83,"phoneExt":24,"email":84},"Demaya Starkes","443-923-3832","starkesd@kennedykrieger.org",{"name":86,"role":52,"phone":24,"phoneExt":24,"email":24},"Doris G Leung, MD, PhD",{"facility":88,"status":34,"city":89,"state":90,"zip":91,"country":38,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"University of Massachusetts Chan Medical School","Worcester","Massachusetts","01605",{"type":40,"coordinates":93},[94,95],-71.80229,42.26259,{"lat":95,"lon":94},[98,102],{"name":99,"role":28,"phone":100,"phoneExt":24,"email":101},"Catherine Douthwright","508-865-1524","Catherine.Douthwright@umassmed.edu",{"name":24,"role":28,"phone":24,"phoneExt":24,"email":103},"FSHDresearch@umassmed.edu",{"facility":105,"status":34,"city":106,"state":107,"zip":108,"country":38,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Utah Program for Inherited Neuromuscular Disorders - University of Utah","Salt Lake City","Utah","84112",{"type":40,"coordinates":110},[111,112],-111.89105,40.76078,{"lat":112,"lon":111},[115,119],{"name":116,"role":28,"phone":117,"phoneExt":24,"email":118},"Ryan Kennington","801-587-0833","ryan.kennington@hsc.utah.edu",{"name":120,"role":52,"phone":24,"phoneExt":24,"email":24},"Russell Butterfield, MD, PhD",{"facility":122,"status":34,"city":123,"state":124,"zip":125,"country":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Royal Alfred Hospital","Sydney","New South Wales","2050","Australia",{"type":40,"coordinates":128},[129,130],151.20732,-33.86785,{"lat":130,"lon":129},[133,137,140],{"name":134,"role":28,"phone":135,"phoneExt":24,"email":136},"Sasan Mortazavi","612 9515 4867","SLHD-RPACMTTrials@health.nsw.gov.au",{"name":138,"role":28,"phone":139,"phoneExt":24,"email":136},"Miles Kenny","612 9515 8453",{"name":141,"role":52,"phone":24,"phoneExt":24,"email":24},"Katrina Anne Morris, BMedSCI, MBBS(Hons), PhD,FRACP",{"facility":143,"status":34,"city":144,"state":24,"zip":145,"country":146,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Pacific Clinical Research Network","Auckland","0622","New Zealand",{"type":40,"coordinates":148},[149,150],174.76349,-36.84853,{"lat":150,"lon":149},[153],{"name":154,"role":28,"phone":155,"phoneExt":24,"email":156},"Miriam Rodrigues","64-021896662","mrodrigues@adhb.govt.nz",{"type":158,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":170,"type":171},12,"ESTIMATED","INTERVENTIONAL",[174,175],"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.",[178],"Facioscapulohumeral Muscular Dystrophy",[178,21,180],"Muscular Dystrophy","2026-04-20",{"date":183,"type":184},"2026-04-22","ACTUAL",{"date":186,"type":184},"2025-05-08",{"date":188,"type":171},"2032-04-30",{"name":5,"class":6},7]