Overview

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

Status:
Completed
Trial end date:
2020-06-18
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Shanghai Biomabs Pharmaceutical Co., Ltd.
Treatments:
Denosumab