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RECRUITING
NCT06667453
PHASE2

A Clinical Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1

Sponsor: PepGen Inc

View on ClinicalTrials.gov

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

Interventions

DRUG

PGN-EDODM1

Administered by intravenous (IV) infusion

OTHER

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