Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers

Summary

Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan. Study Design: This is a single-dose study to assess the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow comparison of PK data from different groups using data from the same study under the same controlled conditions. Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up to 100 days.

Timeline

Start

2011-09

Primary completion

2012-02

Completion

2012-02

Drugs

Indications

No indication recorded.