NCT01397539

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

A Randomized, Blinded, Placebo-Controlled Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB037 in Subjects With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BIIB037 is an investigational product being developed as a treatment for Alzheimer's disease (AD). BIIB037 is a fully human immunoglobulin gamma 1 (IgG1) monoclonal antibody that is selective for the fibrillar form of beta amyloid (Aß).

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	BIIB037	Participants receive a single dose of BIIB037 by intravenous (IV) infusion in cohorts assigned to the following ascending doses: .03 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, and 60 mg/kg.
OTHER	Placebo	Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-07-19
• Last updated: 2015-03-23

Locations

3 sites across 1 country: United States