drugset / Trial / NCT05808673
Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blinded, controlled Phase I three-arms study of CMAB807X administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807X Pre- and Post-change in Manufacturing Site, and Post-change CMAB807X versus Xgeva® #Denosumab# in healthy male subjects after a single dose
Timeline
- Start
- 2023-02
- Primary completion
- 2024-06
- Completion
- 2024-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CMAB807X | Unknown | 120 mg | Subcutaneous |
| Comparator | Denosumab | Monoclonal antibody | 120 mg | Subcutaneous |
Indications
No indication recorded.