RecruitingPhase 1NCT05668403

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

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


Sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd

Enrollment

52 participants

Start Date

Mar 2, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I clinical trial testing a new antibody drug given by injection under the skin for people with primary membranous nephropathy — a kidney disease where the immune system attacks the kidney's filtering units, causing protein to leak into the urine. The drug targets a protein called CD20 found on certain immune cells (B cells) that drive this autoimmune attack. This trial tests whether the drug is safe and how the body responds to it. **You may be eligible if...** - You are between 18 and 75 years old - You have primary membranous nephropathy confirmed by kidney biopsy - Your blood pressure is reasonably controlled (systolic 140 mmHg or below, diastolic 90 mmHg or below) - If you take blood pressure medications (ACE inhibitors or ARBs), you have been on a stable dose for at least 4 weeks - You are able to follow the study protocol **You may NOT be eligible if...** - Your membranous nephropathy is caused by another condition (secondary type) - You have had uncontrolled blood pressure in the past 3 months - Your urine protein has already dropped by 50% or more in the past 6 months - You are currently on dialysis or receiving kidney replacement therapy - You have type 1 or diabetic type 2 kidney disease - You have a history of active tuberculosis or current serious infection - You have had a live vaccine, major surgery, or another clinical trial within the past 28 days - You are pregnant, breastfeeding, or not using adequate contraception - You have hepatitis B, hepatitis C, or a history of immune deficiency **Talk to your doctor if** you have been diagnosed with membranous nephropathy and are looking for treatment options beyond standard medications.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGB007

Drug: B007 injection Drug: Placebo injection

DRUGB007

Drug: B007 injection Drug: Placebo injection

DRUGB007

Drug: B007 injection Drug: Placebo injection


Locations(6)

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

View Full Details on ClinicalTrials.gov

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NCT05668403


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