[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Epibiotech\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100640900","phase-1-study-of-epi-001-in-patients-with-androgenetic-alopecia-100640900",false,"NCT07618195","Study of EPI-001 in Patients With Androgenetic Alopecia","Phase I\u002FIIa Study to Evaluate the Safety, Tolerability, and Efficacy of EPI-001 in Patients With Androgenetic Alopecia","Inclusion Criteria:\n\n1. Male or female subjects aged 19 years or older\n2. Subjects diagnosed with androgenetic alopecia\n3. Subjects willing to maintain the same hairstyle, hair length, and hair color during the study period\n4. Subjects willing to refrain from prohibited hair-related products or procedures during the study period\n5. Subjects willing to undergo scalp tattooing and hair trimming for phototrichogram evaluation\n6. Subjects who voluntarily signed written informed consent\n\nExclusion Criteria:\n\n1. Subjects who used prohibited medications or therapies affecting hair growth within the protocol-defined period\n2. Subjects with scalp diseases or hair disorders other than androgenetic alopecia\n3. Subjects with autoimmune diseases affecting the scalp or hair\n4. Subjects with clinically significant cardiovascular, renal, endocrine, infectious, or systemic diseases\n5. Subjects positive for HBV, HCV, HIV, or syphilis screening tests\n6. Subjects with a history of hair transplantation, stem cell therapy, or gene therapy\n7. Subjects with hypersensitivity related to the investigational product or study procedures\n8. Pregnant or breastfeeding women\n9. Subjects who participated in another clinical study within the protocol-defined period\n10. Subjects judged inappropriate for study participation by the investigator","ALL","19 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase I\u002FIIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of EPI-001 in patients with androgenetic alopecia.\n\nIn the Phase I portion, a traditional 3+3 dose-escalation design will be used to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EPI-001. Subjects will be followed for up to 24 weeks after administration.\n\nIn the Phase IIa portion, subjects will be randomized in a 2:1 ratio to receive either EPI-001 or placebo. Safety and efficacy will be evaluated through hair count assessment, hair diameter measurement, clinical photography, investigator assessment, expert panel assessment, and subject self-assessment during a follow-up period of up to 48 weeks.",[27],"Androgenetic Alopecia",[29,30,31,32,33,34],"Hair Loss","Alopecia","Autologous Cell Therapy","Hair Regeneration","Dermal Papilla Cell","Cell therapy","RECRUITING","2026-05-26",{"date":38,"type":39},"2026-06-01","ACTUAL",{"date":41,"type":39},"2026-01-12",{"date":43,"type":20},"2029-06-01",{"name":45,"class":46},"Epibiotech","INDUSTRY",""]