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Clinical Trial 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


Clinical Trial 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 1:1 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 Design


Related Conditions & MeSH terms


NCT number NCT06361355
Study type Interventional
Source Taizhou Mabtech Pharmaceutical Co.,Ltd
Contact Hu Wei, Doctor
Phone 0551-65997164
Email hwgcp@ayefy.com
Status Recruiting
Phase Phase 1
Start date November 2, 2023
Completion date June 2024

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