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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    52
  • sponsor
    Shanghai Jiaolian Drug Research and Development Co., Ltd
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Updated on 10 April 2023
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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

Details
Condition Primary Membranous Nephropathy
Treatment B007
Clinical Study IdentifierNCT05668403
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd
Last Modified on10 April 2023

Eligibility

 Yes No Not Sure

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
Subjects with glomerular filtration rate ≥ 45 mL/min/1.73 m2 estimated by CKD-EPI equation(the Chronic Kidney Disease Epidemiology Collaboration equation), or endogenous creatinine clearance ≥ 45 mL/min based on 24-hour urine collection
If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 8 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
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 or HBV(hepatitisBvirus) DNA ≥ the upper limit of laboratory normal at screening; those with positive hepatitis C virus antibody or HCV(hepatitis C virus) RNA ≥ the upper limit of laboratory normal at screening; 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
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