NCT01943513

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

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of Intravenous BIIB023 (Anti-TWEAK) on Lower Limb Muscle Mass and Strength During and After Knee-Joint Immobilization in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Biogen · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	BIIB023	Intravenous (IV) infusions
BIOLOGICAL	Placebo	Matched placebo

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-01-01
• Completion: 2014-05-01
• First posted: 2013-09-17
• Last updated: 2014-09-03

Locations

1 site across 1 country: United States