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

Clinical Trial Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Xgeva® 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 Xgeva® in healthy volunteers.

The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of QL1206 or Xgeva® in healthy volunteers.

Meanwhile，observing the pharmacodynamic similarities of QL1206 or Xgeva® preliminarily.

Subjects would receive a single 120mg（1.7ml） of QL1206 or through subcutaneous injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03651947
Study type Interventional
Source Qilu Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date August 20, 2018
Completion date May 22, 2019
View Details
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