drugset / Trial / NCT05853354
Comparative Efficacy, Safety, PK, and Immunogenicity Study
RandomizedParallel-groupQuadruple-blindOther
Summary
this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women with osteoporosis.
Timeline
- Start
- 2023-04-05
- Primary completion
- 2025-07-30
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |