About this trial
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
Eligibility criteria
Qualifiers
Subjects who have fully understood this study and voluntarily signed the informed consent form;
Male or female subjects, aged between 18 and 75 years;
Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;
Disqualifiers
Subjects with secondary membranous nephropathy;
Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
Subjects with decreases in urine protein ≥ 50% within 6 months before screening;
Subjects who have received or are receiving renal replacement therapy;
Trial design
Treatments tested in this trial
- B007
- B007
- B007
Treatment groups
Sponsors and collaborators
Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborator