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
NCT ID: NCT05668403
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
52 participants
INTERVENTIONAL
2023-03-02
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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B007:350mg
B007:350mg Subcutaneous injection was administered on days 1 and 15
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
B007
Drug: B007 injection Drug: Placebo injection
B007:700mg
B007: 700mg Subcutaneous injection was administered on days 1 and 15
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
B007
Drug: B007 injection Drug: Placebo injection
B007:1000mg
B007: 1000mg Subcutaneous injection was administered on days 1 and 15
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
B007
Drug: B007 injection Drug: Placebo injection
Interventions
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B007
Drug: B007 injection Drug: Placebo injection
B007
Drug: B007 injection Drug: Placebo injection
B007
Drug: B007 injection Drug: Placebo injection
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Shanghai Jiaolian Drug Research and Development Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, He'nan, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The First Affiliated Hospital,College of Medicine,Zhejiang University
Hangzhou, Zhejiang, China
Peking university first hospital
Beijing, , China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, , China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B007-102
Identifier Type: -
Identifier Source: org_study_id
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