Exploratory Study of NS-089/NCNP-02 in DMD

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

December 2, 2019

Primary Completion Date

May 31, 2022

Study Completion Date

May 31, 2022

Conditions
Duchenne Muscular Dystrophy
Interventions
DRUG

NS-089/NCNP-02

"NS-089/NCNP-02 for Infusion is packaged as 50 mg/mL with 3 mL per vial. Study dosages will be infused over a 1 hour period at the following dose levels.~\[Part 1\] NS-089/NCNP-02 is administered at dose levels 1 and 3 in Cohort 1 and at dose levels 2 and 4 in Cohort 2.~Dose level 1: 1.62 mg/kg once weekly for 2 weeks; Dose level 2: 10 mg/kg once weekly for 2 weeks; Dose level 3: 40 mg/kg once weekly for 2 weeks; Dose level 4: 80 mg/kg once weekly for 2 weeks \[Part 2\] Based on the results from Part 1, two dosages are selected as study dosages in Part 2. Each selected dose are administered once a week for 24 weeks."

Trial Locations (1)

1878551

National Center of Neurology and Psychiatry, Kodaira

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Nippon Shinyaku Co., Ltd.

INDUSTRY

lead

National Center of Neurology and Psychiatry, Japan

OTHER

NCT04129294 - Exploratory Study of NS-089/NCNP-02 in DMD | Biotech Hunter | Biotech Hunter