NCT04494373

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

A Randomized, Double-blinded and Parallel Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）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 subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. Meanwhile，observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.

Conditions

• Bone Metastasis From Solid Tumors

Interventions

Type	Name	Description
DRUG	HS-20090	A human IgG2 monoclonal antibody with affinity and specificity for human RANKL
DRUG	Xgeva®	A human IgG2 monoclonal antibody with affinity and specificity for human RANKL

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2020-07-31
• Last updated: 2020-08-04