NCT03651947

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy People

Interventions

Type	Name	Description
DRUG	QL1206	subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.
DRUG	Xgeva®	subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.

Timeline

• Start date: 2018-08-20
• Primary completion: 2018-11-17
• Completion: 2019-05-22
• First posted: 2018-08-29
• Last updated: 2019-10-16

Locations

1 site across 1 country: China