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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 35
Updated:5/3/2014
Start Date:October 2013
End Date:May 2014
Contact:Biogen Clinical Trials
Email:immunologyclinicaltrials@biogenidec.com

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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

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


Inclusion Criteria:

- Deemed healthy as determined by the Investigator based on medical history, 12-lead
electrocardiogram, vital signs, and clinical laboratory parameters at Screening, and
physical examination at Baseline

- Body mass index (BMI) between 18.5 and 32 kg/m2, inclusive, at the time of Screening

- Willing to abstain from using tobacco and tobacco-containing products during the
study

- Willing to limit the intake of alcohol to no more than 2 units per day throughout the
study; exceptions are 48 hours prior to Screening, 48 hours prior to Day 1, and
during the in-clinic immobilization period when no alcohol will be permitted. One
unit of alcohol is defined as 12 fluid ounce (fl oz) of beer, 5 fl oz of wine, or 1.5
fl oz of liquor

- Willing to maintain a regular diet for the duration of the study and a recreational
level of physical activity defined as participation in an exercise program or other
physical activity at a level of intensity that does not exceed the level prior to
study entry

- Practice effective contraception during the study and be willing and able to continue
contraception for at least 6 months after the last dose of study treatment.

Exclusion Criteria:

- History of or positive test result at Screening for human immunodeficiency virus
(HIV).

- History or positive test result at Screening for hepatitis C virus (HCV) antibody or
hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or
hepatitis B core antibody [HBcAb]).

- History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test. There must be
no other clinical evidence of TB on physical examination of the subject.

- Use of tobacco or tobacco-containing products within 3 months prior to Screening

- Known history of thrombophilia, hypercoagulopathy, or prior history of deep vein
thrombosis (DVT) or pulmonary embolism (PE)

- History of physical activity consistent with endurance training or resistance
training within 6 months prior to Screening

- Any back, leg, knee, or shoulder complaints that may interfere with the use of
crutches

- Prolonged travel (more than 6 hours) within 2 weeks prior to randomization.
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