Actively Recruiting
A Phase I Clinical Study to Evaluate 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
Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-04-30
52
Participants Needed
6
Research Sites
52 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
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of a recombinant humanized anti-CD20 monoclonal antibody given by subcutaneous injection for treating primary membranous nephropathy. This Phase I clinical study aims to better understand how this treatment works and its potential benefits for patients with this kidney condition. Participants are randomly assigned to receive one of three doses of the study drug B007—350mg, 700mg, or 1000mg—or a matching placebo. Each dose is given by subcutaneous injection on days 1 and 15. The study uses a double-blind design to compare the effects of the active drug versus placebo. Treatment and observation extend over approximately two years to assess safety and clinical outcomes. During the trial, participants undergo regular monitoring for dose-limiting toxicities and treatment-emergent adverse events. Pharmacokinetic and pharmacodynamic profiles, immunogenicity, and relevant biomarkers are measured over about one year. The study also tracks the proportion of subjects achieving clinical remission over two years. Researchers collect safety data and evaluate how the study drug behaves in the body to inform future research and treatment development.
CONDITIONS
Brief 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
- If taking ACEI (Angiotensin converting enzyme inhibitors), ARB (Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required
- 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 as judged by the investigator 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 those with type 2 diabetes mellitus diagnosed as diabetic nephropathy by biopsy
- Subjects who have a history of tuberculosis or have received anti-tuberculosis treatment
- Subjects with active infections requiring systemic antibiotics or antiviral therapy
- Subjects with known severe allergic reactions to humanized monoclonal antibodies
- Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug
- Pregnant or lactating women; women of childbearing potential who have not been sterilized and do not agree to use contraception during treatment and for 12 months after
- Subjects with serious, progressive, or uncontrolled diseases increasing risk during study participation
- Subjects with a history of alcoholism or drug abuse within 12 months
- Subjects with positive hepatitis B surface antigen or hepatitis C virus antibody or history of immunodeficiency
- Subjects with CD4+ T lymphocyte count below 300 cells/bcL
- Other conditions unsuitable for participation as determined by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 to 2 years
Participants receive subcutaneous injections of B007 or placebo on days 1 and 15 to evaluate safety, tolerability, and preliminary efficacy.
2 visits for injections and multiple follow-up visits for safety and efficacy assessments
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
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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