drugset / Trial / NCT02434718

Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease

NCT02434718

Phase 1 Completed 21 enrolled Biogen
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of Aducanumab on immunogenicity.

Timeline

Start
2015-06-24
Primary completion
2016-12-09
Completion
2016-12-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Aducanumab Monoclonal antibody Intravenous

Indications