NCT04798313

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults

A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW031 and Prolia® 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 MW031 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 MW031 and Prolia® in healthy volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers. At the same time, preliminary evaluate the pharmacodynamic similarity between MW031 and Prolia®. Subjects would receive a single 60mg（1mL）of MW031 or Prolia® through subcutaneous injection.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	MW031	Subjects would receive a single 60mg (1 mL) of MW031 through subcutaneous injection, on the first day of treatment.
DRUG	Prolia®	Subjects would receive a single 60mg (1 mL) of Prolia® through subcutaneous injection, on the first day of treatment.

Timeline

• Start date: 2020-06-02
• Primary completion: 2020-12-07
• Completion: 2020-12-31
• First posted: 2021-03-15
• Last updated: 2021-03-15

Locations

1 site across 1 country: China