Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05777109
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-03-08
Brief Title:
Comparing of the PK PD Safety and Immunogenicity of HS-20090 and Xgeva in Healthy Adults
Sponsor:
Jiangsu Hansoh Pharmaceutical Co Ltd
Organization:
Jiangsu Hansoh Pharmaceutical Co Ltd
Study Overview
Official Title:
A Dual-center Randomized Double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic Pharmacodynamics Safety and Immunogenicity of HS-20090 Injection and Xgeva in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2023-08
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:
A Dual-center Randomized double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic pharmacodynamics Safety and Immunogenicity of HS-20090 Injection and Xgeva in Healthy Adults
Detailed Description:
This is a phase I dual-center randomized double-blind and parallel group clinical trial
The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090 or Xgeva in healthy volunteers
The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva in healthy volunteers Meanwhile observing the pharmacodynamic similarity of HS-20090 to Xgeva preliminarily
The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090 or Xgeva in healthy volunteers
The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva in healthy volunteers Meanwhile observing the pharmacodynamic similarity of HS-20090 to Xgeva preliminarily
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