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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: Completed Phase 1 study, sponsored by Biogen.
NCT01943513 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01943513 record still lists
NCT01943513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01943513 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01943513's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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