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

NCT06053814 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Nippon Shinyaku Co., Ltd.

    collaborator INDUSTRY

  • NS Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
15 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-18
Primary Completion
2027-05-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Japan
  • South Korea
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053814 on ClinicalTrials.gov