NCT06361355

Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Post-change CMAB807	for subcutaneous injection only
BIOLOGICAL	Prolia	for subcutaneous injection only

Timeline

• Start date: 2023-11-02
• Primary completion: 2024-06-03
• Completion: 2024-07-05
• First posted: 2024-04-11
• Last updated: 2024-11-07

Locations

1 site across 1 country: China