[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567381":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":141,"collaborators":25,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":145,"sex":151,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":25,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"PepGen Inc","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PGN-EDODM1","EXPERIMENTAL","Participants will be randomized to receive ascending doses of PGN-EDODM1, once every 4 weeks (Q4W) for 12 weeks",[13],"Drug: 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7DN",{"type":45,"coordinates":135},[136,137],-1.61396,54.97328,{"lat":137,"lon":136},[140],{"name":52,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":142,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100567381","phase-2-a-clinical-study-of-pgn-edodm1-in-people-with-myotonic-dystrophy-type-1-100567381",false,"NCT06667453","A Clinical Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1","A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PGN-EDODM1 in Adult Participants With Myotonic Dystrophy Type 1 (FREEDOM2-DM1)","FREEDOM2-DM1","Inclusion Criteria:\n\n* Confirmed diagnosis of DM1, as defined as having a repeat sequence in the DMPK gene with at least 100 CTG repeats\n* Presence of myotonia\n* Have sufficient muscle mass in bilateral tibialis anterior (TA) muscles that a needle biopsy can safely be performed\n* Body Mass Index (BMI) of \\\u003C 35.0 kg\u002Fm\\^2\n\nExclusion Criteria:\n\n* Congenital DM1\n* Known history or presence of any clinically significant conditions that may interfere with study safety assessments\n* Abnormal laboratory tests at screening considered clinically significant by the Investigator\n* Medications specific for the treatment of myotonia within 2 weeks prior to screening\n* Percent predicted forced vital capacity (FVC) \\\u003C40%\n* Use of an investigational drug, device, or product within 30 days of 5 half-lives of the study drug (whichever is longer) prior to Screening\n\nNote: Other inclusion and exclusion criteria may apply.","ALL","16 Years","65 Years",{"count":155,"type":156},24,"ESTIMATED","INTERVENTIONAL",[159],"PHASE2","The purpose of this study is to learn about the effects of an investigational medicine, PGN-EDODM1, to see how safe and tolerable multiple administrations of PGN-EDODM1 are for people with myotonic dystrophy type 1 (DM1) compared to placebo.",[162],"Myotonic Dystrophy 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