Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1

ClinicalTrials.gov ID: NCT05481879

Public ClinicalTrials.gov record NCT05481879. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 19, 2026, 1:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1

Study identification

NCT ID: NCT05481879
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Dyne Therapeutics; Industry
Enrollment: 116 participants

Conditions and interventions

Conditions

Myotonic Dystrophy Type 1 (DM1)

Interventions

DYNE-101 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 4, 2022
Primary completion: Jun 30, 2029
Completion: Jun 30, 2029
Last update posted: May 11, 2026

2022 – 2029

United States locations

U.S. sites: 8
U.S. states: 8
U.S. cities: 8

Facility	City	State	ZIP	Site status
Stanford University	Stanford	California	94305	Recruiting
University of Florida College of Medicine	Gainesville	Florida	32610	Recruiting
Indiana University School of Medicine	Indianapolis	Indiana	46202	Recruiting
University of Iowa	Iowa City	Iowa	52242	Recruiting
Washington University in St. Louis	St Louis	Missouri	63110	Recruiting
University of Rochester Medical Center	Rochester	New York	14642	Recruiting
Neurology Rare Disease Center	Denton	Texas	76208	Recruiting
Virginia Commonwealth University (VCU)	Richmond	Virginia	23298	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05481879, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 11, 2026 · Synced May 19, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05481879 live on ClinicalTrials.gov.

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