Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04152759
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2019-09-09
Brief Title:
Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi in Healthy Subjects
Sponsor:
Bio-Thera Solutions
Organization:
Bio-Thera Solutions
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None