RecruitingPhase 2NCT06667453

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

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)

Sponsor

PepGen Inc

Enrollment

24 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

Myotonic Dystrophy 1

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.

Eligibility

Min Age: 16 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PGN-EDODM1 and Placebo for people with myotonic dystrophy 1. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 16 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPGN-EDODM1

Administered by intravenous (IV) infusion

OTHERPlacebo

Administered by intravenous (IV) infusion

Locations(12)

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

Pusan National University Yangsan Hospital

Pusan, Gyeongsangnam-do, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Seoul National University Hospital

Seoul, South Korea

Salford Royal Hospital

Salford, England, United Kingdom

University College London Hospitals NHS Foundation Trust

London, UK, United Kingdom

Cardiff and Vale Hospital

Cardiff, United Kingdom

Newcastle Upon Tyne Hospitals

Newcastle upon Tyne, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06667453

Related Trials

Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1) Extension

NCT077002251 location

Study of SRP-1003 in Participants With Type 1 Myotonic Dystrophy

NCT0613874311 locations

Estab Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)

NCT0398157517 locations

An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)

NCT072206033 locations

Study of ATX-01 in Participants With DM1

NCT0630030712 locations