Trials / Recruiting
RecruitingNCT06667453
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- PepGen Inc · Industry
- Sex
- All
- Age
- 16 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PGN-EDODM1 | Administered by intravenous (IV) infusion |
| OTHER | Placebo | Administered by intravenous (IV) infusion |
Timeline
- Start date
- 2024-12-10
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2024-10-31
- Last updated
- 2026-03-02
Locations
8 sites across 3 countries: Canada, New Zealand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06667453. Inclusion in this directory is not an endorsement.