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Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults — MW031  

Osteoporosis, Postmenopausal Clinical Trial

Official title:
A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW031 and Prolia® in Healthy Adults

Clinical Trial Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.

Clinical Trial Description

This is a phase I, single center, randomized, double-blind and parallel group clinical trial. The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers. At the same time, preliminary evaluate the pharmacodynamic similarity between MW031 and Prolia®. Subjects would receive a single 60mg（1mL）of MW031 or Prolia® through subcutaneous injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04798313
Study type Interventional
Source Mabwell (Shanghai) Bioscience Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date June 2, 2020
Completion date December 31, 2020
View Details
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