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NCT01943513 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effect of BIIB023 on Muscle Atrophy in Healthy Male Volunteers
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01943513 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 34 participants.
The verdict
NCT01943513, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
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
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL BIIB023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01943513
The ClinicalTrials.gov registry entry for NCT01943513 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01943513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01943513 about?
NCT01943513 is a clinical study titled "A Study of the Effect of BIIB023 on Muscle Atrophy 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 immo...
What is the current status of trial NCT01943513?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2013-10. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01943513?
The interventions under investigation include: Placebo (BIOLOGICAL), BIIB023 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01943513?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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