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

Shanghai Jiaolian Drug Research and Development Co., Ltd5 sites in 1 country52 target enrollmentMarch 2, 2023

ConditionsPrimary Membranous Nephropathy

InterventionsB007

DrugsB007

Overview

Phase: Phase 1
Intervention: B007
Conditions: Primary Membranous Nephropathy
Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Enrollment: 52
Locations: 5
Primary Endpoint: Dose limiting toxicity（DLT）
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2, 2023

End Date

December 30, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 ≤ 140 mmHg and diastolic blood pressure ≤ 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.

Exclusion Criteria

•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 ≥ 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 who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
•Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
•Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;
•Subjects with known history of 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 do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;