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A Double-blind, Escalating Dose, Randomized, Placebo-controlled Study Assessing PK, Safety, Tolerability in Non-ambulant DMD Subjects

NCT01128855 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-07-18

No results posted yet for this study

Summary

The purpose of this study is investigate the pharmacokinetics, safety and tolerability of single subcutaneous administration of GSK2402968 in non-ambulant boys with Duchenne muscular dystrophy

Conditions

  • Muscular Dystrophies

Interventions

DRUG

3 mg/kg GSK2402968

Weekly subcutaneous injection

DRUG

6 mg/kg GSK2402968

Weekly subcutaneous injection

DRUG

9 mg/kg GSK2402968

Weekly subcutaneous injection

DRUG

12 mg/kg GSK2402968

Weekly subcutaneous injection

OTHER

Placebo

Weekly Placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-12
Primary Completion
2011-10-25
Completion
2011-10-25

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Companies

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 NCT01128855 on ClinicalTrials.gov