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RECRUITING
NCT05668403
PHASE1

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

Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2023-03-02

Completion Date

2027-12-30

Last Updated

2025-02-10

Healthy Volunteers

No

Interventions

DRUG

B007

Drug: B007 injection Drug: Placebo injection

DRUG

B007

Drug: B007 injection Drug: Placebo injection

DRUG

B007

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