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

Sponsors and collaborators

Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborator