RecruitingPhase 2NCT07220603
An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
An Open-Label Extension Study Evaluating Safety and Pharmacokinetics in Participants With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
Sponsor
PepGen Inc
Enrollment
48 participants
Start Date
Dec 23, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Participant has completed a prior study with PGN-EDODM1
Exclusion Criteria2
- Abnormal laboratory tests at screening considered clinically significant by the Investigator
- Use of an investigational drug (other than PGN-EDODM1), device, or product, within 30 days or 5 half-lives of the study drug (whichever is longer) prior to study entry
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Interventions
DRUGPGN-EDODM1
Administered by intravenous (IV) infusion
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT07220603
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