[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Epicrispr Biotechnologies, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28],"Facioscapulohumeral Muscular Dystrophy",[28,30,31],"EPI-321","Muscular Dystrophy","RECRUITING","2026-04-20",{"date":35,"type":36},"2026-04-22","ACTUAL",{"date":38,"type":36},"2025-05-08",{"date":40,"type":21},"2032-04-30",{"name":42,"class":43},"Epicrispr Biotechnologies, Inc.","INDUSTRY",7,""]