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

Shanghai Jiaolian Drug Research and Development

Status and phase: Enrolling; Phase 1

Conditions: Primary Membranous Nephropathy

Treatments: Drug: B007

Study type: Interventional

Funder types: Industry

Identifiers

NCT05668403

B007-102

Details and patient eligibility

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

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who have fully understood this study and voluntarily signed the informed consent form;
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

1. Subjects with secondary membranous nephropathy;
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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52 participants in 3 patient groups

B007:350mg

Experimental group

Description:

B007:350mg Subcutaneous injection was administered on days 1 and 15 B007 matched Placebo Subcutaneous injection was administered on days 1 and 15

Treatment:

Drug: B007

Drug: B007

Drug: B007

B007:700mg

Experimental group

Description:

B007: 700mg Subcutaneous injection was administered on days 1 and 15 B007 matched Placebo Subcutaneous injection was administered on days 1 and 15

Treatment:

Drug: B007

Drug: B007

Drug: B007

B007:1000mg

Experimental group

Description:

B007: 1000mg Subcutaneous injection was administered on days 1 and 15 B007 matched Placebo Subcutaneous injection was administered on days 1 and 15

Treatment:

Drug: B007

Drug: B007

Drug: B007