It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi® (EU-licensed ). The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Golimumab, thus to evaluate the change and similarity of the pharmacokinetics of the two study drugs. The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi® (EU-licensed ). The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Golimumab, thus to evaluate the change and similarity of the pharmacokinetics of the two study drugs. The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
182
Drug: BAT2506 injection Each subject will receive single subcutaneous injection of 50 mg BAT2506 Injection or Simponi(EU-licensed). Other Names: Simponi(EU-licensed)
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Pharmacokinetics Endpoint:AUC0-t
Pharmacokinetics Endpoint:AUC0-t
Time frame: 0-71days
Pharmacokinetics Endpoint:Cmax
Pharmacokinetics Endpoint:Cmax
Time frame: 0-71days
Pharmacokinetics Endpoint:AUC0-inf
Pharmacokinetics Endpoint:AUC0-inf
Time frame: 0-71days
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