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

Last updated: February 7, 2025
Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Glomerulonephritis

Nephrotic Syndrome

Idiopathic Membranous Nephropathy

Treatment

B007

Clinical Study ID

NCT05668403
B007-102
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects who have fully understood this study and voluntarily signed the informedconsent form;

  2. Male or female subjects, aged between 18 and 75 years;

  3. Subjects with primary membranous nephropathy pathologically confirmed by renalbiopsy;

  4. Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90mmHg at screening;

  5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptorblocker), a stable dose within 4 weeks before screening is required;

  6. Subjects who are able to follow the study protocol as judged by the investigator.

Exclusion

Exclusion Criteria:

  1. Subjects with secondary membranous nephropathy;

  2. Subjects with uncontrolled blood pressure as judged by the investigator within 3months 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 whoare diagnosed as diabetic nephropathy by percutaneous renal biopsy;

  6. Subjects who have a clear history of tuberculosis or have received anti-tuberculosistreatment;

  7. Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or otherinfections requiring systemic antibiotics or antiviral therapy;

  8. Subjects with known history of severe allergic reactions to humanized monoclonalantibodies;

  9. Subjects who received live vaccination, major surgery, or participated in otherclinical trials within 28 days before receiving the study drug;

  10. Pregnant or lactating women; women of childbearing potential who have not beensterilized do not agree to use appropriate contraceptive measures during treatmentand for at least 12 months after the last dose of the study drug;

  11. Subjects with serious, progressive, or uncontrolled disease that may increase risksduring 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 Cvirus 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 theInvestigator.

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: B007
Phase: 1
Study Start date:
March 02, 2023
Estimated Completion Date:
December 30, 2027

Connect with a study center

  • Hebei General Hospital

    Shijiazhuang, Hebei 050057
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 410100
    China

    Active - Recruiting

  • The First Affiliated Hospital,College of Medicine,Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Peking university first hospital

    Beijing, 100010
    China

    Active - Recruiting

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    Shanghai, 200032
    China

    Active - Recruiting

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