NCT05668403 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 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Jiaolian Drug Research and Development Co., Ltd |
| Condition | Primary Membranous Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2023-03-02 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2023-03-02 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05668403 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Membranous Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05668403 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05668403 currently recruiting?
Yes, NCT05668403 is actively recruiting participants. Contact the research team at mhzhao@bjmu.edu.cn for enrollment information.
Where is the NCT05668403 trial being conducted?
This trial is being conducted at Zhengzhou, China, Shijiazhuang, China, Hangzhou, China, Beijing, China and 2 additional locations.
Who is sponsoring the NCT05668403 clinical trial?
NCT05668403 is sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd. The trial plans to enroll 52 participants.