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

Exclusion Criteria

• •1. Subjects with secondary membranous nephropathy;
• •2. Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
• •3. Subjects with decreases in urine protein ≥ 50% within 6 months before screening;
• •4. Subjects who have received or are receiving renal replacement therapy;
• •5. Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
• •6. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
• •7. Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;
• •8. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies；
• •9. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
• •10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;
• •11. Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;
• •12. Subjects with a history of alcoholism or drug abuse within 12 months;
• •13. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;
• •14. Subjects with CD4+ T lymphocyte count \< 300 cells/μL;
• •15. Other conditions unsuitable for participation in this study determined by the Investigator.