The primary objective of the study is to assess the safety and tolerability of a single intravenous (IV) dose of dapirolizumab pegol (DZP) in Japanese healthy study participants compared with those of Caucasian healthy study participants. The secondary objectives of the study are to assess the pharmacokinetic(s) (PK) of a single IV dose of DZP in Japanese and Caucasian healthy study participants, to evaluate ethnic sensitivity on the PK of DZP between body weight- and gender-matched Japanese and Caucasian healthy study participants and to evaluate the immunogenicity of a single IV dose of DZP in Japanese and Caucasian healthy study participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Anaheim Clinical Trials
Anaheim, California, United States
Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect.
Time frame: Up to Day 120
Plasma BIIB133 Concentration
Time frame: Up to Day 120
Area under Concentration-Time Curve from Time 0 to Infinity (AUCinf) of BIIB133
Time frame: Up to Day 120
Area under Concentration-Time Curve from Time 0 to Time t (AUC0-t) of BIIB133
Time frame: Up to Day 120
Maximum Observed Concentration (Cmax) of BIIB133
Time frame: Up to Day 120
Time to Reach Maximum Observed Concentration (Tmax) of BIIB133
Time frame: Up to Day 120
Elimination Half-life (t½) of BIIB133
Time frame: Up to Day 120
Clearance (CL) of BIIB133
Time frame: Up to Day 120
Volume of Distribution (Vd) of BIIB133
Time frame: Up to Day 120
Percentage of AUCinf Obtained by Extrapolation (AUCextr%) of BIIB133
Time frame: Up to Day 120
Area under Concentration-Time Curve from Time 0 to Infinity Normalized by Dose (AUCinf/Dose) of BIIB133
Time frame: Up to Day 120
Area under Concentration-Time Curve from Time 0 to Time t Normalized by Dose (AUC0-t/Dose) of BIIB133
Time frame: Up to Day 120
Maximum Observed Concentration Normalized by Dose (Cmax/Dose) of BIIB133
Time frame: Up to Day 120
Plasma Polyethylene Glycol (PEG) Concentration
Time frame: Up to Day 120
AUCinf of PEG
Time frame: Up to Day 120
AUC0-t of PEG
Time frame: Up to Day 120
Cmax of PEG
Time frame: Up to Day 120
Tmax of PEG
Time frame: Up to Day 120
t½ of PEG
Time frame: Up to Day 120
AUCextr% of PEG
Time frame: Up to Day 120
AUCinf/Dose of PEG
Time frame: Up to Day 120
AUC0-t/Dose of PEG
Time frame: Up to Day 120
Cmax/Dose of PEG
Time frame: Up to Day 120
Urine PEG Concentration
Time frame: Up to Day 120
Ratio of AUCinf of BIIB133 between Japanese and Caucasian Participants
Time frame: Up to Day 120
Ratio of AUC0-t of BIIB133 between Japanese and Caucasian Participants
Time frame: Up to Day 120
Ratio of Cmax of BIIB133 between Japanese and Caucasian Participants
Time frame: Up to Day 120
Ratio of t½ of BIIB133 between Japanese and Caucasian Participants
Time frame: Up to Day 120
Ratio of CL of BIIB133 between Japanese and Caucasian Participants
Time frame: Up to Day 120
Ratio of Vd of BIIB133 between Japanese and Caucasian Participants
Time frame: Up to Day 120
Ratio of AUCinf/Dose of BIIB133 between Japanese and Caucasian Participants
Time frame: Up to Day 120
Ratio of AUC0-t/Dose of BIIB133 between Japanese and Caucasian Participants
Time frame: Up to Day 120
Ratio of Cmax/Dose of BIIB133 between Japanese and Caucasian Participants
Time frame: Up to Day 120
Number of Participants with Anti-BIIB133 Antibodies
Time frame: Up to Day 120
Plasma Concentration of Anti-BIIB133 Antibodies
Time frame: Up to Day 120
Number of Participants with Anti-PEG Antibodies
Time frame: Up to Day 120
Plasma Concentration of Anti-PEG Antibodies
Time frame: Up to Day 120
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