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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB023 | Experimental | Participants receive intravenous (IV) infusions of BIIB023 |
|
| Placebo | Placebo Comparator | Participants receive intravenous (IV) infusions of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB023 | Biological | Intravenous (IV) infusions |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in the magnitude of muscle atrophy | between Day 14 and Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Evansville | Indiana | United States |
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| ID | Term |
|---|---|
| D020966 | Muscular Disorders, Atrophic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C586995 | BIIB023 |
| D000074049 | Cytokine TWEAK |
| D000911 | Antibodies, Monoclonal |
| ID | Term |
|---|---|
| D048069 | Tumor Necrosis Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Placebo | Biological | Matched placebo |
|
| 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 |
| Change in the recovery of muscle oxidative metabolism, measured by near-infrared spectroscopy (NIRS) of the quadriceps femoris muscles | between Day 14 and Day 42 |
| The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 156 |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |