Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05808673
Status:
WITHDRAWN
Last Update Posted:
2024-04-09
First Post:
2023-03-27
Brief Title:
Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva in Healthy Volunteers
Sponsor:
Taizhou Mabtech Pharmaceutical CoLtd
Organization:
Taizhou Mabtech Pharmaceutical CoLtd
Study Overview
Official Title:
A Randomized Double-blind Parallel Controlled Phase I Three-arm Study Comparing the PK PD Safety and Immunogenicity of Pre- and Post-change CMAB807X Post-change CMAB807X and Xgeva in Healthy Chinese Male Subjects
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Changes in the companys production plan
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blinded controlled Phase I three-arms study of CMAB807X administered by subcutaneous injection This study will characterize the pharmacokinetic pharmacodynamics safety and immunogenicity of CMAB807X Pre- and Post-change in Manufacturing Site and Post-change CMAB807X versus Xgeva Denosumab in healthy male subjects after a single dose
Detailed Description:
This is a randomized double-blind parallel-controlled single-dose phase I three-arms clinical study in healthy Chinese male subjects A total of 252 subjects were planned to be enrolled and randomly assigned to the test group or the bridging control group or bioequivalence control group in a 111 ratio Subjects in three groups received a single abdominal subcutaneous injection of pre- or post-change CMAB807X or Xgeva Denosumab 120 mg respectively Subjects in three groups were observed for 140 days after administration to evaluate similarities in pharmacokinetics pharmacodynamics safety and immunogenicity
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