drugset / Trial / NCT02641041
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese Participants
RandomizedParallel-groupQuadruple-blindBasic science
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.
Timeline
- Start
- 2016-02
- Primary completion
- 2016-09
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | opicinumab | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Subject | opicinumab | Protein / enzyme biologic | 30 mg/kg | Intravenous |
| Subject | opicinumab | Protein / enzyme biologic | 100 mg/kg | Intravenous |