This is a Phase I, single-centre, open-label, parallel-group, single dose study to evaluate the pharmacokinetics, safety and tolerability of Brazikumab in healthy male and female Chinese participants and healthy male and female White participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
Participants will receive IV or SC injection of brazikumab as per the group they are assigned.
Research Site
Glendale, California, United States
Maximum observed serum (peak) drug concentration (Cmax) of brazikumab
Cmax of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Area under serum concentration-time curve from zero to infinity (AUCinf) of brazikumab
AUCinf of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Area under the serum concentration-time curve from zero to the last quantifiable concentration (AUClast) of brazikumab
AUClast of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Partial area under the serum concentration-time curve from time zero to 28 days postdose (AUC0-28d) of brazikumab
AUC0-28d of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)
Safety and tolerability of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: From Screening period (Day -28 to Day -2) to Day 133 and Early termination visit
Maximum observed serum (peak) drug concentration divided by the dose administered (Dose-normalised Cmax) of brazikumab
Dose-normalised Cmax of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Area under the plasma concentration-time curve from time zero to infinity divided by the dose administered (Dose-normalised AUCinf) of brazikumab
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Dose-normalised AUCinf of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration divided by the dose administered (Dose-normalised AUClast) of brazikumab
Dose-normalised AUClast of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Partial area under the serum concentration-time curve from time zero to 28 days postdose divided by the dose administered (Dose-normalised AUC0-28d) of brazikumab
Dose-normalised AUC0-28d of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Time to reach peak or maximum observed concentration or response following drug administration (tmax) of brazikumab
tmax of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Terminal elimination rate constant (λz) of brazikumab
λz of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) of brazikumab
t1/2λz of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Total body clearance of drug from serum after intravascular administration (CL) of brazikumab (IV only)
CL of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Volume of distribution following intravascular administration (based on terminal phase [Vz]) of brazikumab (IV only)
Vz of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Apparent total body clearance of drug from serum after extravascular administration CL/F of brazikumab (SC only)
CL/F of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Volume of distribution (apparent) following extravascular administration (based on terminal phase [Vz/F]) of brazikumab (SC only)
Vz/F of brazikumab in healthy Chinese and White participants will be evaluated.
Time frame: Day 1 to Day 133
Incidence of positive anti-drug antibodies to brazikumab in serum
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum will be evaluated
Time frame: Day 1 to Day 133