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An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
Sponsor: PepGen Inc
Summary
The purpose of this study is to learn about the long-term safety and tolerability of PGN-EDODM1 in participants with myotonic dystrophy type 1 (DM1) who have completed a prior study with PGN-EDODM1.
Official title: An Open-Label Extension Study Evaluating Safety and Pharmacokinetics in Participants With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-12-23
Completion Date
2029-01
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
PGN-EDODM1
Administered by intravenous (IV) infusion
Locations (3)
University of Calgary
Calgary, Alberta, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
CIUSSS du Saguenay-Lac-Saint-Jean
Saguenay, Canada