Pure Global
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
Taizhou Mabtech Pharmaceutical Co.,Ltd·Phase 1·ClinicalTrials.gov·biologicalRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteers
Drug/Device/Intervention
Post-change CMAB807
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Location
Hefei, China
Timeline & enrollment
Phase
Phase 1
Start date
Nov 02, 2023
End date
Jun 01, 2024
Enrollment
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 personRoutine general health check-up of armed forcesRoutine general health check-up of sports teamsRoutine general health check-up of inhabitants of institutions
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06361355
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.