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NCT05148481 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
A Phase 1 study of Healthy Volunteer, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT05148481: Completed Phase 1 study of Healthy Volunteer, sponsored by Biogen.
NCT05148481 is a Phase 1 study of Healthy Volunteer that has completed, run by Biogen. The registered enrollment target is 31 participants, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05148481, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective of the study is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered twice daily (BID) for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BIIB104
Study Locations (1)
California
- Research Site - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2021-11-23 |
| Est. Completion | 2022-02-12 |
| Phase | Phase 1 |
What the finished NCT05148481 record still lists
NCT05148481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05148481 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05148481 about?
NCT05148481 is a clinical study titled "A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants". The primary objective of the study is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective of the study is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered twice daily (BID) for 9 days, with...
What is the current status of trial NCT05148481?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2021-11-23. Estimated completion is 2022-02-12.
What conditions does trial NCT05148481 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT05148481?
The interventions under investigation include: Placebo (DRUG), BIIB104 (DRUG).
Who is sponsoring clinical trial NCT05148481?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05148481 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05148481's enrollment target sits among peer trials
31 75th of 112 higher than 38 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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.
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