Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT04152759
Brief 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.
Detailed Description:
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:
NCT04152759
Study Brief:
Protocol Section:
NCT04152759