The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of BIIB033-A and BIIB033-B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
28
Research Site
Madison, Wisconsin, United States
PK parameter of BIIB033: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Up to Day 89
PK parameter of BIIB033: Area under the concentration-time curve from time 0 to Day 85 (AUC84d)
Time frame: Day 85
PK parameter of BIIB033: Maximum observed concentration (Cmax)
Time frame: Up to Day 89
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 17 weeks
Number of participants with clinically significant laboratory parameters
Time frame: Up to 17 weeks
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to 17 weeks
Number of participants with clinically significant electrocardiograms (ECGs) abnormalities
Time frame: Up to 17 weeks
Number of participants with clinically significant physical examination abnormalities
Time frame: Up to 17 weeks
PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)
Time frame: Up to Day 89
PK parameter of BIIB033: Terminal elimination half-life (t1/2)
Time frame: Up to Day 89
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PK parameter of BIIB033: Volume of distribution at steady state (Vss)
Time frame: Up to Day 89
PK parameter of BIIB033: Clearance (CL)
Time frame: Up to Day 89
Number of participants with presence of anti-BIIB033 antibodies
Time frame: Pre-dose, Day 22 and Day 85