This study is a Phase 1b/2a, open-label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, and PD of VB119 in subjects with primary MN
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.
Clinical Reserach Site
Los Angeles, California, United States
Clinical Research Site
Albany, New York, United States
Clinical Research Site
Bethlehem, Pennsylvania, United States
Clinical Research Site
Dallas, Texas, United States
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability
Time frame: Through study completion, an average of 18 months
Incidence of Clinical Laboratory Assessments
Safety and Tolerability
Time frame: Through study completion, an average of 18 months
% of Patients with Anti-Drug Antibodies
Time frame: Through study completion, an average of 18 months
Maximum Plasma Concentration [Cmax]
Time frame: Week 12
Time to Maximum Plasma Concentration [Tmax]
Time frame: Week 12
% of patients achieving complete remission of proteinuria
Time frame: Through study completion, an average of 18 months
Anti-PLA2R Antibody Assessment
Time frame: Through study completion, an average of 18 months
Quality of Life as assessed by PROMIS
Time frame: Through study completion, an average of 18 months
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