This trial is conducted in China. The purpose of this study is to evaluate the pharmacokinetic similarity of Tafolecimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process,also to determine Pharmacodynamics of Tafolecimab with different manufacturing process
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
166
450mg,SC,single dose
450mg,SC,single dose
Aerospace Center Hospital
Beijing, China
Bioequivalence results using the peak serum drug concentration (Cmax) as the judging indicators
Time frame: up to Day 57
Bioequivalence results using the area under the serum concentration-time curve (AUC0-inf) as the judging indicators
Time frame: up to Day 57
Other PK parameters: Area under the plasma concentration-time curve (AUClast)
Time frame: up to Day 57
Other PK parameters: Volume of distribution (V)
Time frame: up to Day 57
Other PK parameters: elimination half-life (t1/2)
Time frame: up to Day 57
Number of participants with adverse events, with abnormal vital signs, abnormal physical examination, abnormal laboratory test results and abnormal ECG readings
Time frame: up to Day 57
The occurrence of Anti-drug Antibody(ADA)
Time frame: up to Day 57
The occurrence of Neutralizing antibodies Antibody(NAb)
Time frame: up to Day 57
Percentage Change from baseline in Low Density Lipoprotein choleterol (LDL-C)
Time frame: up to Day 57
Percentage Change from baseline in Proprotein convertase subtilisin/kexin type 9(PCSK-9)
Time frame: up to Day 57
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