The study of EN001 in patients with Duchenne muscular dystrophy

The research company ENCell is conducting the clinical trial Determine the Safety and Dose of EN001 in Patients With Duchenne Muscular Dystrophy.

It is planned to include 12 participants.

Actual study start date is December 10, 2021. The researchers expect to complete the study by August 19, 2027.

One primary outcome measure is Number of participants with Vital Signs abnormalities, Vital Signs include blood pressure (mmHg), pulse (times/minute), respiratory rate (times/minute), and body temperature (℃) and will be assessed by CTCAE v 5.0 to evaluate safety and tolerability of EN001. The number of participants with at least one potentially clinically significant abnormal vital sign finding were reported as treatment emergent adverse events (TEAEs).

Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05338099