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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Primary Membranous Nephropathy

In brief

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

Key facts

Study ID

NCT05668403

Run by

Shanghai Jiaolian Drug Research and Development Co., Ltd

People needed

52

Starts

2023-03-02

Expected to finish

2027-12-30

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;
• Subjects with known history of severe allergic reactions to humanized monoclonal antibodies；
• Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
• 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;
• Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;
• Subjects with a history of alcoholism or drug abuse within 12 months;
• Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;
• Subjects with CD4+ T lymphocyte count < 300 cells/μL;
• Other conditions unsuitable for participation in this study determined by the Investigator.

Where it is running

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, He'nan, China (enrolling)
• Hebei General Hospital — Shijiazhuang, Hebei, China (enrolling)
• The First Affiliated Hospital,College of Medicine,Zhejiang University — Hangzhou, Zhejiang, China (enrolling)
• Peking university first hospital — Beijing, China (enrolling)
• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai, China (enrolling)
• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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