Condition: Duchenne Muscular Dystrophy (DMD) · Sponsor: Entrada Therapeutics, Inc.
This is a study of the investigational medicine ENTR-601-44 in participants who have Duchenne muscular dystrophy (DMD), a rare genetic condition. The researchers want to: Test how safe ENTR-601-44 is, learn about any side effects, and look at the potential positive effects of ENTR-601-44, compared to placebo. Placebo looks like the investigational medicine but does not contain any active ingredient. In this summary ENTR-601-44 and placebo are both called study treatments. The study has 2 parts: * Part A * A Double-Blind Period, to evaluate if ENTR-601-44 is safe and to determine the best dose of ENTR-601-44 for Part B. * Following the Double-Blind period, participants will roll into an open-label treatment period during which the safety and efficacy of extended dosing will be evaluated. * Part B * To further evaluate the effect and safety of ENTR-601-44 at the dose determined in Part A. Participants will: * Receive study treatment in the form of multiple intravenous (IV) infusions (slow injection) into a vein over the course of several weeks in Part A and in Part B * Visit the clinic regularly for checkups and tests such as: blood and urine tests, physical examinations, questionnaires, and exercise tests. Participants will have a muscle biopsy at the beginning of their participation and after their last dose to allow researchers to compare whether there have been changes in the muscle as a result of the study drug. Participants are allowed to continue receiving …
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| University Hospital Gent | Ghent, Belgium | Recruiting |
| UZ Leuven | Leuven, Belgium | Recruiting |
| Centre Hospitalier Régional de la Citadelle | Liège, Belgium | Recruiting |
| IRCCS Ospedale San Raffaele | Milan, Italy | Recruiting |
| Fondazione Serena Onlus - Centro Clinico NeMO Milano | Milan, Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesu | Rome, Italy | Recruiting |
| Hospital Universitario Vall d'Hebron | Barcelona, Spain | Recruiting |
| Hospital Sant Joan de Deu | Barcelona, Spain | Recruiting |
| Leeds General Infirmary | Leeds, United Kingdom | Recruiting |
| Alder Hey Children's NHS Foundation Trust | Liverpool, United Kingdom | Not Yet Recruiting |
| Great Ormond Street Hospital for Children | London, United Kingdom | Recruiting |
| Royal Manchester Children's Hospital | Manchester, United Kingdom | Not Yet Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07037862