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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
24
Research Site
Leeds, West Yorkshire, United Kingdom
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to day 113
Number of participants with clinically significant laboratory parameters
Time frame: Up to day 113
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to day 113
Number of participants with clinically significant electrocardiograms (ECGs) abnormalities
Time frame: Up to day 113
Number of participants with clinically significant physical examination abnormalities
Time frame: Up to day 113
Number of participants with clinically significant neurological examination abnormalities
Time frame: Up to day 113
PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: Up to day 113
PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Time frame: Up to day 113
PK parameter of BIIB033: AUC over a given dosing interval
Time frame: Up to day 113
PK parameter of BIIB033: Maximum observed concentration (Cmax)
Time frame: Up to day 113
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PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)
Time frame: Up to day 113
PK parameter of BIIB033: Terminal elimination half-life (t1/2)
Time frame: Up to day 113
PK parameter of BIIB033: Volume of distribution at steady state (Vss)
Time frame: Up to day 113
PK parameter of BIIB033: Clearance (CL)
Time frame: Up to day 113
PK parameter of BIIB033: accumulation ratio (RAC)
Time frame: Up to day 113
Number of participants with positive serum BIIB033 antibodies
Time frame: Up to day 113