drugset / Trial / NCT05216887
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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-02-01
- Primary completion
- 2022-07-27
- Completion
- 2022-07-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aducanumab | Monoclonal antibody | — | Intravenous |
Indications
No indication recorded.