NCT04798326

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults

A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW032 and Xgeva® in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 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 MW032 and Xgeva® in healthy volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers. At the same time, preliminary evaluate the pharmacodynamic similarity between MW032 and Xgeva®. Subjects would receive a single 120mg（1.7mL）of MW032 or Xgeva® through subcutaneous injection.

Conditions

• Bone Tumor

Interventions

Type	Name	Description
DRUG	MW032	Subjects would receive a single 120mg (1.7 mL) of MW032 through subcutaneous injection, on the first day of treatment.
DRUG	Xgeva®	Subjects would receive a single 120mg (1.7 mL) of Xgeva® through subcutaneous injection, on the first day of treatment.

Timeline

• Start date: 2019-06-25
• Primary completion: 2020-01-10
• Completion: 2020-02-26
• First posted: 2021-03-15
• Last updated: 2021-03-15

Locations

1 site across 1 country: China