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Exploratory Study of NS-065/NCNP-01 in DMD

NCT02081625 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-02-26

No results posted yet for this study

Summary

This study is designed to assess the safety, tolerability, efficacy and pharmacokinetics (PK) of NS-065/NCNP-01 in subjects diagnosed with Duchenne muscular dystrophy (DMD).

Conditions

Interventions

DRUG

NS-065/NCNP-01

NS-065/NCNP-01 for Infusion is packaged as 25 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows: Cohort 1: 1.25mg/kg once weekly for 12 weeks; Cohort 2: 5.0mg/kg once weekly for 12 weeks; Cohort 3: 20.0mg/kg once weekly for 12 weeks

Sponsors & Collaborators

  • Nippon Shinyaku Co., Ltd.

    collaborator INDUSTRY

  • National Center of Neurology and Psychiatry, Japan

    lead OTHER

Principal Investigators

  • Shin'ichi Takeda, MD, PhD · National center of Neurology and Psychiatry

  • Hirofumi Komaki, MD, PhD · National center of Neurology and Psychiatry

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-11-30
Completion
2015-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT02081625 on ClinicalTrials.gov