Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361355
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-07
Brief Title:
Study of CMAB807 Post-change in Manufacturing Site and Prolia 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 Study Comparing the PK PD Safety and Immunogenicity of Post-change CMAB807and Prolia in Healthy Chinese Subjects
Status:
RECRUITING
Status Verified Date:
2023-11
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:
This is a randomized double-blinded parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection This study will characterize the pharmacokinetic pharmacodynamics safety and immunogenicity of CMAB807 Post-change in Manufacturing Site versus Prolia Denosumab in healthy male subjects after a single dose
Detailed Description:
This is a randomized double-blind parallel-controlled single-dose phase I clinical study in healthy Chinese male subjects A total of 132 subjects were planned to be enrolled and randomly assigned to the test group or bioequivalence control group in a 11 ratio Subjects in two groups received a single abdominal subcutaneous injection of post-change CMAB807 or Prolia Denosumab 60 mg respectively Subjects in three groups were observed for 126 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