drugset / Trial / NCT03242512
Assessment of Anti-RANKL Antibody in Post-menopausal Women
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Subject | Denosumab | Monoclonal antibody | 120 mg | Subcutaneous |