drugset / Trial / NCT01397539

Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease

NCT01397539

Phase 1 Completed 53 enrolled Biogen
RandomizedSingle-groupDouble-blindTreatment

Summary

The primary objective of the study is to evaluate the safety and tolerability of a range of BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of BIIB037 after single-dose administration.

Timeline

Start
2011-06
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Aducanumab Monoclonal antibody 0.03 mg/kg Intravenous
Subject Aducanumab Monoclonal antibody 1 mg/kg Intravenous
Subject Aducanumab Monoclonal antibody 3 mg/kg Intravenous
Subject Aducanumab Monoclonal antibody 10 mg/kg Intravenous
Subject Aducanumab Monoclonal antibody 20 mg/kg Intravenous
Subject Aducanumab Monoclonal antibody 30 mg/kg Intravenous
Subject Aducanumab Monoclonal antibody 60 mg/kg Intravenous

Indications