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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
participants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group
Research Site
Leeds, United Kingdom
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Up to Day 105
Maximum observed concentration (Cmax)
Time frame: Up to Day 105
Time to reach maximum observed concentration (Tmax)
Time frame: Up to Day 105
Terminal elimination half-life (t1/2)
Time frame: Up to Day 105
Apparent volume of distribution (Vd/F)
Time frame: Up to Day 105
Apparent clearance (CL/F)
Time frame: Up to Day 105
The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 105
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