drugset / Trial / NCT03242512

Assessment of Anti-RANKL Antibody in Post-menopausal Women

NCT03242512

Phase 1 Unknown 24 enrolled Jiangsu T-Mab Biopharma Co.,Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a single-center, open-label, dose-escalating study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of single dose subcutaneous injection of a fully human monoclonal antibody of receptor activator for nuclear factor-κ B ligand (RNAKL) (code name: TK006) in postmenopausal women.

Timeline

Start
2017-08-07
Primary completion
2018-12-30
Completion
2018-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 30 mg Subcutaneous
Subject Denosumab Monoclonal antibody 60 mg Subcutaneous
Subject Denosumab Monoclonal antibody 120 mg Subcutaneous

Indications