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NCT05481879 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1
A Phase 1 study of Myotonic Dystrophy Type 1 (DM1), sponsored by Dyne Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
- 17
- Study locations
NCT05481879: Recruiting Phase 1 study of Myotonic Dystrophy Type 1 (DM1), sponsored by Dyne Therapeutics.
NCT05481879 is a Phase 1 study of Myotonic Dystrophy Type 1 (DM1) that is actively recruiting participants, run by Dyne Therapeutics. The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). The trial reports 17 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05481879, a Phase 1 study of Myotonic Dystrophy Type 1 (DM1), is actively recruiting participants, sponsored by Dyne Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
- 17
- Study locations
Study Summary
The primary purpose of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of DYNE-101 administered to participants with Myotonic Dystrophy Type 1 (DM1). The study consists of 4 periods: A Screening Period (up to 8 weeks), a Placebo-Controlled Period (24 weeks), a Treatment Period (24 weeks) and a Long-Term Extension (LTE) Period (168 weeks) in both multiple-ascending dose (MAD) and dose expansion cohorts.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DYNE-101
Study Locations (17)
Other
- CHU de Nantes - Nantes
- Institut de Myologie - Paris
- Charité - Universitätsmedizin Berlin - Berlin
- Ludwig Maximilians University, Munich - Friedrich Baur Institut - Munich
- Centro Clinico Nemo - Milan
- Fondazione Policlinico Universitario A Gemelli-Rome - Rome
- Radboud Medical Center - Nijmegen
- NZCR Auckland - Auckland
- University College London Hospitals - London
- John Walton Muscular Dystrophy Research Centre - Newcastle upon Tyne
- Salford Royal Hospital - Salford
Indiana
- Indiana University School of Medicine - Indianapolis
Iowa
- University of Iowa - Iowa City
New York
- University of Rochester Medical Center - Rochester
Texas
- Neurology Rare Disease Center - Denton
Virginia
- Virginia Commonwealth University (VCU) - Richmond
Victoria
- St. Vincent's Hospital - Fitzroy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2022-09-05 |
| Est. Completion | 2029-07 |
| Phase | Phase 1 |
What NCT05481879 shows while recruiting
NCT05481879 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher).
The record links to 1 condition, with Myotonic Dystrophy Type 1 (DM1) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05481879 lists 17 locations in 7 states (Other, Indiana, Iowa).
Frequently Asked Questions
What is clinical trial NCT05481879 about?
NCT05481879 is a clinical study titled "Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1". The primary purpose of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of DYNE-101 administered to participants with Myotonic Dystrophy Type 1 (DM1). The study consists of 4 periods: A Screening Period (up to 8 weeks), a Placebo-Controlled Period (24 weeks), ...
What is the current status of trial NCT05481879?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2022-09-05. Estimated completion is 2029-07.
What conditions does trial NCT05481879 study?
This clinical trial studies the following conditions: Myotonic Dystrophy Type 1 (DM1).
What interventions are being tested in trial NCT05481879?
The interventions under investigation include: Placebo (DRUG), DYNE-101 (DRUG).
Who is sponsoring clinical trial NCT05481879?
This trial is sponsored by Dyne Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05481879 being conducted?
This trial has 17 study locations across Indiana, Iowa, New York, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05481879's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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