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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Primary Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	B007	Drug: B007 injection Drug: Placebo injection
DRUG	B007	Drug: B007 injection Drug: Placebo injection
DRUG	B007	Drug: B007 injection Drug: Placebo injection

Timeline

• Start date: 2023-03-02
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2022-12-29
• Last updated: 2025-02-10

Locations

6 sites across 1 country: China