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Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults

Healthy People Clinical Trial

Official title:
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults

Clinical Trial Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 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 QL1206 or Prolia® in healthy volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of QL1206 or Prolia® in healthy volunteers. Meanwhile，observing the pharmacodynamic similarities of QL1206 or Prolia® preliminarily. Subjects would receive a single 60mg（1ml） of QL1206 or through subcutaneous injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04213105
Study type Interventional
Source Qilu Pharmaceutical Co., Ltd.
Contact shunjiang yu, CMO
Phone 0531-83129659
Email shunjiang.yu@qilu-pharma.com
Status Recruiting
Phase Phase 1
Start date October 31, 2019
Completion date October 31, 2020
View Details
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