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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • B007
  • B007
  • B007

Treatment groups

52 Participants
are divided into 3 treatment groups

Locations

6
The First Affiliated Hospital of Zhengzhou University410100, ZhengzhouHe'nan, China
Hebei General Hospital050057, ShijiazhuangHebei, China
The First Affiliated Hospital,College of Medicine,Zhejiang University310003, HangzhouZhejiang, China
Peking university first hospital100010, Beijing China

Sponsors and collaborators

Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborator