drugset / Trial / NCT05668403
A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy
Phase 1
Recruiting
52 enrolled
Shanghai Jiaolian Drug Research and Development Co., Ltd
Shanghai Pharmaceuticals Holding Co., Ltd · collab
RandomizedSequentialDouble-blindTreatment
Summary
This Phase I Clinical Study assessed the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy
Timeline
- Start
- 2023-03-02
- Primary completion
- 2026-12-30
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | B007 | Monoclonal antibody | 350 mg | Subcutaneous |
| Subject | B007 | Monoclonal antibody | 700 mg | Subcutaneous |
| Subject | B007 | Monoclonal antibody | 1000 mg | Subcutaneous |