NCT02641041

Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese Participants

A Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of BIIB033 administered as single and multiple doses in healthy adult Japanese participants and to assess the single-dose and multiple-dose immunogenicity of BIIB033.

Conditions

• Central Nervous System (CNS) Demyelinating Disease
• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	BIIB033	single or multiple dose
OTHER	Placebo	single or multiple dose

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-12-29
• Last updated: 2016-10-10

Locations

1 site across 1 country: United Kingdom