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A Study of the Effect of BIIB023 on Muscle Atrophy in Healthy Male Volunteers

NCT01943513 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2014-09-03

No results posted yet for this study

Summary

The primary objective of this study is to determine whether muscle atrophy induced by immobilization of the lower limb can be attenuated by BIIB023 in healthy male volunteers. The secondary objectives of this study in this study population are:

* To determine whether muscle weakness induced by immobilization of the lower limb can be attenuated by BIIB023
* To assess the effect of BIIB023 on the recovery of muscle mass and strength after immobilization
* To assess the effect of BIIB023 on histological markers of muscle atrophy and regeneration
* To assess the effect of BIIB023 on muscle bioenergetics based on oxidative metabolism recovery kinetics
* To evaluate the safety and tolerability of BIIB023

Conditions

  • Healthy

Interventions

BIOLOGICAL

BIIB023

Intravenous (IV) infusions

BIOLOGICAL

Placebo

Matched placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-01-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01943513 on ClinicalTrials.gov