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Clinical Trials in South Korea / NCT06667453
Recruiting Phase 2

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

NCT06667453 · tracked via the Priya Life Science South Korea tracker
Sponsor
PepGen Inc
Phase
Phase 2
Started
2024-12-10
Last updated
2026-07-29

Condition(s) studied

Myotonic Dystrophy 1

Investigational drug(s) / intervention(s)

PGN-EDODM1 →Placebo

PGN-EDODM1: Administered by intravenous (IV) infusion

Placebo: Administered by intravenous (IV) infusion

Study 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

Sex
ALL
Min age
16 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Confirmed diagnosis of DM1, as defined as having a repeat sequence in the DMPK gene with at least 100 CTG repeats * Presence of myotonia * Have sufficient muscle mass in bilateral tibialis anterior (TA) muscles that a needle biopsy can safely be performed * Body Mass Index (BMI) of \< 35.0 kg/m\^2 Exclusion Criteria: * Congenital DM1 * Known history or presence of any clinically significant conditions that may interfere with study safety assessments * Abnormal laboratory tests at screening considered clinically significant by the Investigator * Medications specific for the treatment of myotonia within 2 weeks prior to screening * Percent predicted forced vital capacity (FVC) \<40% * Use of an investigational drug, device, or product within 30 days of 5 half-lives of the study drug (whichever is longer) prior to Screening Note: Other inclusion and exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
University of Calgary Calgary Alberta Recruiting
Ottawa Hospital Research Institute (OHRI) Ottawa Ontario Recruiting
CIUSSS du Saguenay-Lac-Saint-Jean Chicoutimi Quebec Recruiting
Montreal Neurological Institute Montreal Quebec Recruiting
Pacific Clinical Research Network Auckland Takapuna Auckland Recruiting
Pusan National University Yangsan Hospital Pusan Gyeongsangnam-do Recruiting
Kyungpook National University Chilgok Hospital Daegu South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Salford Royal Hospital Salford England Recruiting
University College London Hospitals NHS Foundation Trust London UK Recruiting
Cardiff and Vale Hospital Cardiff United Kingdom Recruiting
Newcastle Upon Tyne Hospitals Newcastle upon Tyne United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06667453 on ClinicalTrials.gov ↗ ← All trials in South Korea