NCT05808673

Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (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, 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 1:1:1 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Post-change CMAB807X	for subcutaneous injection only
BIOLOGICAL	Pre-change CMAB807X	for subcutaneous injection only
BIOLOGICAL	Xgeva®	for subcutaneous injection only

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-06-01
• Completion: 2024-07-01
• First posted: 2023-04-11
• Last updated: 2024-04-09

Locations

1 site across 1 country: China