The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
Shanghai Xuhui Central Hospital /ID# 212830
Shanghai, Shanghai Municipality, China
Number of Participants with Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 140 Days
Maximum Observed Concentration (Cmax)
Maximum observed concentration.
Time frame: Up to Approximately 140 Days
Time to Cmax (Tmax)
Time to Cmax.
Time frame: Up to Approximately 140 Days
Terminal Phase Elimination Rate Constant (β)
Terminal phase elimination rate constant.
Time frame: Up to Approximately 140 Days
Terminal Phase Elimination Half-life (t1/2)
Terminal phase elimination half-life.
Time frame: Up to Approximately 140 Days
Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
AUC from time 0 to time of the last measurable concentration (AUCt).
Time frame: Up to Approximately 140 Days
AUC from Time 0 to Infinity (AUCinf)
AUC from time 0 to infinity (AUCinf).
Time frame: Up to Approximately 140 Days
Apparent Clearance (CL/F) for Subcutaneous (SC) dosing
CL/F for SC dosing.
Time frame: Up to Approximately 140 Days
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Clearance (CL) for Intravenous (IV) Dosing
CL for IV dosing.
Time frame: Up to Approximately 140 Days
Number of Anti-drug antibody (ADA) Titers
ADA titers will be tabulated for each participant at the respective study visits.
Time frame: Up to Approximately 140 Days