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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
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
Conditions
Interventions
B007
Drug: B007 injection Drug: Placebo injection
B007
Drug: B007 injection Drug: Placebo injection
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