Evaluate the Efficacy and Safety of EN001 in Patients With Duchenne Muscular Dystrophy

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

March 31, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Duchenne Muscular Dystrophy
Interventions
DRUG

EN001

"Phase 1~* Cohort 1: EN001 5.0x10\^5 cells/kg administered intravenously (IV) 3 times at 6 week intervals.~* Cohort 2: EN001 2.5x10\^6 cells/kg administered intravenously (IV) 3 times at 6 week intervals.~Phase 2~* Experimental Group: The recommended phase 2 dose (RP2D) of EN001 is administered intravenously (IV) three times at six-week intervals.~* Control Group: EN001 placebo is administered intravenously (IV) three times at six-week intervals."

Trial Locations (2)

Unknown

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ENCell

INDUSTRY