drugset / Trial / NCT06361355
Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #Denosumab# in healthy male subjects after a single dose
Timeline
- Start
- 2023-11-02
- Primary completion
- 2024-06-03
- Completion
- 2024-07-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CMAB807 | Monoclonal antibody | 60 mg | Subcutaneous |
| Comparator | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
Indications
No indication recorded.