NCT01929746

Daclizumab Japanese PK Study

A Single-Dose, Single-Blind, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIIB019, Daclizumab High Yield Process (DAC HYP), in Japanese and Caucasian Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019 (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75 mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of this study in this study population is to assess the safety and tolerability of BIIB019 administered as a single SC dose (75 mg or 150 mg).

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	BIIB019 subcutaneous injection	participants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-08-28
• Last updated: 2014-05-02

Locations

1 site across 1 country: United Kingdom