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RECRUITING
NCT06053814
PHASE1/PHASE2

NS-050/NCNP-03 in Boys With DMD (Meteor50)

Sponsor: NS Pharma, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 1/2 study of Multiple-Ascending Dose (MAD) levels for 12 weeks of treatment followed by 24 weeks of open-label treatment with a selected dose of NS-050/NCNP-03 administered once weekly to ambulant boys with DMD, who have a DMD exon deletion amenable to exon 50 skipping.

Official title: A Phase 1/2, First in Human, Multiple-dose, 2-part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NS-050/NCNP-03 in Boys With Duchenne Muscular Dystrophy (DMD)

Key Details

Gender

MALE

Age Range

4 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-09-18

Completion Date

2027-05

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

DRUG

NS-050/NCNP-03

NS-050/NCNP-03 solution for IV infusion.

DRUG

Placebo

NS-050/NCNP-03 placebo-matching solution for IV infusion.

Locations (18)

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Alberta Children's Hospital

Calgary, Alberta, Canada

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

London Health Sciences Centre

London, Ontario, Canada

National Hospital Organization Nagara Medical Center

Nagara, Gifu, Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

NHO Osaka Toneyama Medical Center

Toyonaka, Osaka, Japan

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Istanbul University

Istanbul, Turkey (Türkiye)

Yeditepe University Kosuyolu Hospital

Istanbul, Turkey (Türkiye)