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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 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 123 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05216887
The ClinicalTrials.gov registry entry for NCT05216887 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 123 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 1 intervention - of which Aducanumab is the first listed.
NCT05216887 reports 0 study locations.
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.
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