MedTrace Logo

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

NCT03925051 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2020-10-14

No results posted yet for this study

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.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Prolia®

mAb targeting RANKL. human monoclonal antibody targeting RANKL.

DRUG

CMAB807

human monoclonal antibody targeting RANKL.

Sponsors & Collaborators

  • Shanghai Biomabs Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • xuening li, PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-03-21
Completion
2020-06-18

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03925051 on ClinicalTrials.gov