Actively Recruiting
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
Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-04-30
52
Participants Needed
6
Research Sites
252 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead Sponsor
S
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 64 140 mmHg and diastolic blood pressure 64 90 mmHg at screening
- Subjects taking ACEI or ARB must have a stable dose within 4 weeks before screening
- Subjects who are able to follow the study protocol as judged by the investigator
You will not qualify if you...
- Subjects with secondary membranous nephropathy
- Subjects with uncontrolled blood pressure within 3 months before screening
- Subjects with decreases in urine protein 65 50% within 6 months before screening
- Subjects who have received or are receiving renal replacement therapy
- Subjects with type 1 diabetes mellitus or diabetic nephropathy diagnosed by biopsy
- Subjects with a clear history of tuberculosis or received anti-tuberculosis treatment
- Subjects with active infections requiring systemic antibiotics or antiviral therapy
- Subjects with severe allergic reactions to humanized monoclonal antibodies
- Subjects who received live vaccination, major surgery, or participated in other trials within 28 days before study drug
- Pregnant or lactating women; women of childbearing potential not agreeing to contraception during and 12 months after treatment
- Subjects with serious, progressive, or uncontrolled disease increasing risks as assessed by investigator
- Subjects with history of alcoholism or drug abuse within 12 months
- Subjects positive for hepatitis B surface antigen, hepatitis C antibody, or with immunodeficiency
- Subjects with CD4+ T lymphocyte count less than 300 cells/bcL
- Other conditions assessed by investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, He'nan, China, 410100
Actively Recruiting
2
Hebei General Hospital
Shijiazhuang, Hebei, China, 050057
Actively Recruiting
3
The First Affiliated Hospital,College of Medicine,Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
4
Peking university first hospital
Beijing, China, 100010
Actively Recruiting
5
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, China, 200032
Actively Recruiting
6
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, China, 200032
Actively Recruiting
Research Team
M
Minghui Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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