NCT03925051

Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers

A Randomized, Double-masked, Parallel-group Study, to Compare Pharmacokinetics, Safety and Immunogenicity of CMAB807 Injection Versus Prolia® in Healthy Chinese Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of postmenopausal women with osteoporosis at increased/high risk of fracture. This phase 1 clincical study investigates the pharmacokinetics, safety and immnogenicity of CMAB807,compared to prolia®, in healthy Chinese male subjects.

Detailed description

This is a phase 1 single center, randomized, double-masked, parallel-group clinical trial. The primary objective is to assess the pharmacokinetics similarity of single and subcutaneous injection of CMAB807 injection or Prolia® in health volunteers. The secondary objectives are to assess the clinical safety and immnogenicity similarity of single and subcutaneous injection of CMAB807 or Prolia® in healty volunteers. Meanwhile, exploring the pharmacodynamic similarities of CMAB807 and Prolia®. Subjects will receive a single 60mg of CMAB807 or Prolia® through subcutaneous injection.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Prolia®	mAb targeting RANKL. human monoclonal antibody targeting RANKL.
DRUG	CMAB807	human monoclonal antibody targeting RANKL.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-03-21
• Completion: 2020-06-18
• First posted: 2019-04-23
• Last updated: 2020-10-14

Locations

1 site across 1 country: China