A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal… (NCT05668403) | Clinical Trial Compass
RecruitingPhase 1
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
China52 participantsStarted 2023-03-02
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
✓. Subjects who are able to follow the study protocol as judged by the investigator.
Exclusion criteria
✕. 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;
✕. Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
✕. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
What they're measuring
1
Dose limiting toxicity（DLT）
Timeframe: Approximately 1 years
2
Security: Incidence of Treatment-Emergent Adverse Events
Timeframe: Approximately 2 years
Trial details
NCT IDNCT05668403
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd