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

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID
NCT05216887
Run by
Biogen
People needed
123
Starts
2022-02-01
Expected to finish
2022-07-27
Last updated by the study team
2023-04-18

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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