NCT04673799

Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Kunming Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

Detailed description

This is a phase I, double center, randomized, double-blind, single dose and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of MV088 and Prolia® in healthy volunteers. The secondary objectives is to assess the similarity of clinical safety and immunogenicity of MV088 and Prolia® in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MV088 injection	MV088 injection (60mg) by subcutaneous injection once on the first day
DRUG	Prolia® injection	Prolia® injection (60mg) by subcutaneous injection once on the first day

Timeline

• Start date: 2021-02-22
• Primary completion: 2021-10-18
• Completion: 2021-10-18
• First posted: 2020-12-17
• Last updated: 2020-12-17