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Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers - Trial NCT06361355

Access comprehensive clinical trial information for NCT06361355 through Pure Global AI's free database. This Phase 1 trial is sponsored by Taizhou Mabtech Pharmaceutical Co.,Ltd and is currently Recruiting. The study focuses on Healthy Volunteers. Target enrollment is 132 participants.

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NCT06361355
Phase 1
Recruiting
biological
Trial Details
ClinicalTrials.gov • NCT06361355
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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

Study Focus

Healthy Volunteers

Post-change CMAB807

Interventional

biological

Sponsor & Location

Taizhou Mabtech Pharmaceutical Co.,Ltd

Hefei, China

Timeline & Enrollment

Phase 1

Nov 02, 2023

Jun 01, 2024

132 participants

Primary Outcome

Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time,Maximum Concentration of Denosumab

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

ICD-10 Classifications

Healthy person accompanying sick person
Routine general health check-up of armed forces
Routine general health check-up of sports teams
Routine general health check-up of inhabitants of institutions

Data Source

ClinicalTrials.gov

NCT06361355

Non-Device Trial