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NCT05216887 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 123
- Enrollment target
NCT05216887: Completed Phase 1 study, sponsored by Biogen.
NCT05216887 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 123 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (105% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05216887, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 123 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single, weight-based IV dose of aducanumab.
Interventions
- BIOLOGICAL Aducanumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2022-07-27 |
| Phase | Phase 1 |
What the finished NCT05216887 record still lists
NCT05216887 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (105% higher).
The record links to 0 conditions, and to 1 intervention - of which Aducanumab is the first listed.
NCT05216887 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05216887 about?
NCT05216887 is a clinical study titled "A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers". The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerabi...
What is the current status of trial NCT05216887?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 123 participants. The study started on 2022-02-01. Estimated completion is 2022-07-27.
What interventions are being tested in trial NCT05216887?
The interventions under investigation include: Aducanumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05216887?
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 NCT05216887's enrollment target sits among peer trials
123 475th of 2000 higher than 1,526 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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