Phase I Study of Subcutaneous Recombinant Humanized Anti-CD20 Monoclonal Antibody for Treating Primary Membranous Nephropathy

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of a recombinant humanized anti-CD20 monoclonal antibody given by subcutaneous injection for treating primary membranous nephropathy. This Phase I clinical study aims to better understand how this treatment works and its potential benefits for patients with this kidney condition. Participants are randomly assigned to receive one of three doses of the study drug B007350mg, 700mg, or 1000mgor a matching placebo. Each dose is given by subcutaneous injection on days 1 and 15. The study uses a double-blind design to compare the effects of the active drug versus placebo. Treatment and observation extend over approximately two years to assess safety and clinical outcomes. During the trial, participants undergo regular monitoring for dose-limiting toxicities and treatment-emergent adverse events. Pharmacokinetic and pharmacodynamic profiles, immunogenicity, and relevant biomarkers are measured over about one year. The study also tracks the proportion of subjects achieving clinical remission over two years. Researchers collect safety data and evaluate how the study drug behaves in the body to inform future research and treatment development.

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