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