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Recruiting Phase 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

NCT05668403 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2023-03-02
Last updated
2026-04-30

Condition(s) studied

Primary Membranous Nephropathy

Investigational drug(s) / intervention(s)

B007 →B007 →B007 →

B007: Drug: B007 injection Drug: Placebo injection

B007: Drug: B007 injection Drug: Placebo injection

B007: Drug: B007 injection Drug: Placebo injection

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Subjects who have fully understood this study and voluntarily signed the informed consent form; 2. Male or female subjects, aged between 18 and 75 years; 3. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy; 4. Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening; 5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), 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 Criteria: 1. Subjects with secondary membranous nephropathy; 2. Subjects with uncontrolled blood pressure as judged by the investigator within 3 months 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 who are diagnosed as diabetic nephropathy by percutaneous renal biopsy; 6. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment; 7. Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy; 8. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies; 9. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug; 10. 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; 11. Subjects with serious, progressive, or uncontrolled disease that may increase risks during 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 C virus 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 the Investigator.

Primary outcome measure(s)

  • Dose limiting toxicity(DLT) — Approximately 1 years
    Adverse reactions that are certainly or possibly related to the drug being tested during the dose escalation phase.
  • Security: Incidence of Treatment-Emergent Adverse Events — Approximately 2 years
    Adverse event type, incidence, duration, correlation with study drug

Trial sites (6)

FacilityCityRegionStatus
The First Affiliated Hospital of Zhengzhou University Zhengzhou He'nan Recruiting
Hebei General Hospital Shijiazhuang Hebei Recruiting
The First Affiliated Hospital,College of Medicine,Zhejiang University Hangzhou Zhejiang Recruiting
Peking university first hospital Beijing China Recruiting
Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China Recruiting
Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05668403 on ClinicalTrials.gov ↗ ← All trials in China