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A Clinical Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1
Sponsor: PepGen Inc
Summary
The purpose of this study is to learn about the effects of an investigational medicine, PGN-EDODM1, to see how safe and tolerable multiple administrations of PGN-EDODM1 are for people with myotonic dystrophy type 1 (DM1) compared to placebo.
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PGN-EDODM1 in Adult Participants With Myotonic Dystrophy Type 1 (FREEDOM2-DM1)
Key Details
Gender
All
Age Range
16 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-12-10
Completion Date
2026-08
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
PGN-EDODM1
Administered by intravenous (IV) infusion
Placebo
Administered by intravenous (IV) infusion
Locations (8)
University of Calgary
Calgary, Alberta, Canada
Ottawa Hospital Research Institute (OHRI)
Ottawa, Ontario, Canada
CIUSSS du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
Montreal Neurological Institute
Montreal, Quebec, Canada
Pacific Clinical Research Network Auckland
Takapuna, Auckland, New Zealand
Salford Royal Hospital
Salford, England, United Kingdom
University College London Hospitals NHS Foundation Trust
London, UK, United Kingdom
Newcastle Upon Tyne Hospitals
Newcastle upon Tyne, United Kingdom