Healthy Volunteers Clinical Trial
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
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
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. ;
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