NCT04213105

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• 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 Prolia® 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 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.

Conditions

• Healthy People

Interventions

Type	Name	Description
DRUG	QL1206	subcutaneous injection of 60 mg (1ml) only once,on the first day.
DRUG	Prolia®	subcutaneous injection of 60 mg (1ml)only once,on the first day

Timeline

• Start date: 2019-10-31
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2019-12-30
• Last updated: 2019-12-30

Locations

1 site across 1 country: China