Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects
Status:
Completed
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
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.