The purpose of this study is to evaluate the pharmacokinetic similarity of AK104 with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of AK104 with different manufacturing process.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
100
Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.
Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.
The Third Hospital of Changsha
Changsha, Hunan, China
Pilot study: Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to day 30
Pivotal study: Area under the plasma concentration-time curve (AUC0-infinity)
Time frame: From pre-dose to day 29
Area under the plasma concentration-time curve (AUC0-t)
Time frame: From pre-dose to day 29
Maximum plasma concentration (Cmax)
Time frame: From pre-dose to day 29
Volume of distribution (Vd)
Time frame: From pre-dose to day 29
Clearance (CL)
Time frame: From pre-dose to day 29
Ratio of AUC0-t/AUC0-infinity
Time frame: From pre-dose to day 29
Time to maximum concentration (Tmax)
Time frame: From pre-dose to day 29
Half-life (t1/2)
Time frame: From pre-dose to day 29
Anti-drug Antibody (ADA)
Number and percentage of subjects with detectable ADA
Time frame: From pre-dose to day 29
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