[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Design Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,65],{"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":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100594841","phase-2-dt-168-in-keratoplasty-patients-with-fuchs-endothelial-corneal-dystrophy-100594841",false,"NCT07024693","DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy","A Phase 2, Multicenter, Open-Label Study to Assess the Pharmacodynamics, Safety, and Tolerability of DT-168 Ophthalmic Solution in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Keratoplasty","Inclusion Criteria:\n\n* Participant is scheduled to undergo a keratoplasty for management of FECD independent of this study.\n* ≥30 years of age (inclusive).\n* Documented diagnosis of FECD in the study eligible eye.\n* Confirmation of positive TCF4 allele 18.1 CTG expansion in at least one allele.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Any ocular or medical condition in the study eligible eye which is clinically significant or would confound study results or data interpretation.\n* Any clinically significant medical, nonmedical, and psychiatric disorders that could put the participant at higher risk for participation in the study, impair the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.\n* Concurrent or anticipated need for treatment for FECD, eg, Muro 128 (2% or 5%) during the course of the study in the study eye. Provided the subject undergoes a washout of Muro drops for at least 24 hours prior to the Baseline Visit, they will not be excluded.\n* Concurrent or anticipated use of topical corticosteroids in the study eye.\n* Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor.\n* Known contraindication, allergy, or hypersensitivity to any of the treatments, anesthetics, or diagnostic agents or components thereof which may be used during the study.\n* Use of contact lenses in the study eye within 7 days prior to the Baseline Visit or planned use during the study.\n* Recent (within 30 days of the Screening Visit) or ongoing participation in any other investigational interventional clinical study.\n* Female participant is pregnant, planning a pregnancy, or breast-feeding.\n* Participant is unwilling to comply with the contraceptive requirements, as per protocol.","ALL","30 Years",{"count":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in pre-keratoplasty patients with Fuchs endothelial corneal dystrophy.",[26,27],"Fuchs Endothelial Corneal Dystrophy","Fuchs","RECRUITING","2025-12-24",{"date":31,"type":32},"2025-12-29","ACTUAL",{"date":34,"type":32},"2025-07-30",{"date":36,"type":20},"2026-12",{"name":38,"class":39},"Design Therapeutics, Inc.","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":5},"100583260","phase-1-a-multiple-ascending-dose-study-of-dt-216p2-in-patients-with-friedreichs-ataxia-100583260","NCT06874010","A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia","A Phase 1\u002F2, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intravenous DT-216P2 in Patients With Friedreich's Ataxia","Inclusion Criteria:\n\n* Participants must be 18-65 years of age inclusive, at the time of signing the informed consent.\n* Genetically confirmed diagnosis of FA, with homozygous GAA repeat expansions in the frataxin gene.\n* Stage 5.5 or less on the FSA at screening.\n* BMI between 16 and 32 kg\u002Fm2 at screening; weight should be \\\u003C= 100 kg at screening.\n* Male and\u002For female using protocol defined and regulatory approved contraception.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study protocol.\n* Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.\n* Received an investigational agent within the last 30 days or 5 half-lives, whichever longer, prior to the first dose of study drug, or are in follow-up of another clinical study prior to study enrollment. Exception: Potential participants who are currently on Omaveloxolone must be on stable doses for at least 3 months.\n* Is not willing to comply with the contraceptive requirements during the study period, as per protocol.","18 Years","65 Years",{"count":51,"type":20},20,[53,23],"PHASE1","The purpose of this study is to evaluate the safety and tolerability, and pharmacokinetics of DT-216P2 administered multiple ascending doses in patients with FA.",[56],"Friedreich Ataxia","2025-05-14",{"date":59,"type":32},"2025-05-18",{"date":61,"type":20},"2025-06",{"date":63,"type":20},"2027-03",{"name":38,"class":39},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":16,"minAge":48,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100575483","phase-1-a-single-ascending-dose-study-of-dt-216p2-in-normal-healthy-participants-100575483","NCT06772870","A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants","A Phase 1, Double-Masked, Randomized, Placebo-Controlled, Single Ascending Dose Crossover Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intravenous DT-216P2 in Normal Healthy Participants","Inclusion Criteria:\n\n* Participants must be 18-45 years of age inclusive, at the time of signing the informed consent.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.\n* Agree to abstain from strenuous physical activity outside of daily norm, until end of study.\n* Body mass index between 16 and 32 kg\u002Fm2 (inclusive) at screening; weight should be \\\u003C= 100 kg at screening.\n* Male and\u002For female using protocol defined and regulatory approved contraception.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study protocol.\n* Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.\n* Is not willing to comply with the contraceptive requirements during the study period, as per protocol.",true,"45 Years",{"count":75,"type":20},36,[53],"This purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of DT-216P2 administered either subcutaneously (SC) and intravenously (IV) in normal healthy participants. Approximately 36 participants will be enrolled into this study.",[56],"NOT_YET_RECRUITING","2025-02-20",{"date":82,"type":32},"2025-02-21",{"date":84,"type":20},"2025-02",{"date":86,"type":20},"2025-12",{"name":38,"class":39},1,""]