NCT04198636

A Study to Evaluate LY01011 and Xgeva® in Healthy Adults

A Randomized, Double-blind, Single-dose, Parallel-group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY01011 and Xgeva® in Healthy Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults

Detailed description

This is a phase I, randomized, double-blind, single-dose, parallel-group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers. The secondary objective are to compare the safety, tolerability, immunogenicity and pharmacodynamics of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	LY01011	LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once
DRUG	Xgeva 120 MG in 1.7 ML Injection	Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once

Timeline

• Start date: 2019-12-16
• Primary completion: 2020-12-31
• Completion: 2021-06-30
• First posted: 2019-12-13
• Last updated: 2019-12-13