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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
Drug: B007 injection Drug: Placebo injection
Drug: B007 injection Drug: Placebo injection
Drug: B007 injection Drug: Placebo injection
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, He'nan, China
RECRUITINGHebei General Hospital
Shijiazhuang, Hebei, China
RECRUITINGThe First Affiliated Hospital,College of Medicine,Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGPeking university first hospital
Beijing, China
RECRUITINGLonghua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, China
RECRUITINGLonghua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, China
RECRUITINGDose limiting toxicity(DLT)
Adverse reactions that are certainly or possibly related to the drug being tested during the dose escalation phase.
Time frame: Approximately 1 years
Security: Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration, correlation with study drug
Time frame: Approximately 2 years
PK (Pharmacokinetics)
Cmax
Time frame: Approximately 1 years
PK (Pharmacokinetics)
Tmax
Time frame: Approximately 1 years
PK (Pharmacokinetics)
AUC0-last(Area Under Curve of 0-last)
Time frame: Approximately 1 years
Biomarkers
Changes in serum anti-PLA2R(Antiphospholipase A2 receptor) antibody levels relative to baseline
Time frame: Approximately 1 years
Immunogenicity
Incidence of ADA(Adenosine deaminase)
Time frame: Approximately 1 years
Dynamics of pharmacodynamics
Changes of peripheral blood CD19+B cells(B-lymphocyte antigen CD19) relative to baseline
Time frame: Approximately 1 years
Proportion of subjects achieving clinical remission
Proportion of subjects achieving clinical remission
Time frame: Approximately 2 years
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