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

NCT01943513 | Completed Phase 1

• 1 other identifier: 211HV103
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Muscle Disuse Atrophy

Outcome Measures

Primary Outcomes (1)

• Percentage change in the magnitude of muscle atrophy

  between Day 14 and Day 42

Secondary Outcomes (7)

• Percentage change in the magnitude of muscle atrophy, measured by T1W-MRI analysis of the CSA of the triceps surae muscles of the immobilized limb

  between Day 14 and Day 42

• Percentage change in isometric knee-extension strength (torque), measured by dynamometry

  between Day 14 and Day 42

• Percentage change in isometric plantar-flexion strength (torque), measured by dynamometry

  between Day 14 and Day 42

• Percentage change in total CSA of Type I and II fibers, measured by histological analysis of muscle biopsy

  between Day 14, Day 21, and Day 42

• Change in density of satellite cells and other molecular markers of muscle regeneration, measured by histological analysis of muscle biopsy

  between Day 14, Day 21, and Day 42

Study Arms (2)

BIIB023

EXPERIMENTAL

Participants receive intravenous (IV) infusions of BIIB023

Biological: BIIB023

Placebo

PLACEBO COMPARATOR

Participants receive intravenous (IV) infusions of placebo

Biological: Placebo

Interventions

BIIB023 BIOLOGICAL

Intravenous (IV) infusions

Also known as: (anti-TWEAK [TNF-related Weak Inducer of Apoptosis] monoclonal antibody)

BIIB023

Placebo BIOLOGICAL

Matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Evansville, Indiana, United States

Location

MeSH Terms

Conditions

Muscular Disorders, Atrophic

Interventions

BIIB023; Cytokine TWEAK; Antibodies, Monoclonal

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tumor Necrosis Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 3, 2014

Record last verified: 2014-08

Locations

US (1)