EVER001 is a highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases, which is being developed to treat proteinuric glomerular diseases. The overall aim of the study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of EVER001 in subjects with selected proteinuric glomerular diseases. The first targeted disease is primary membranous nephropathy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The Second Xiangya Hospital Of Central South University
Changsha, Changsha, China
adverse events
Time frame: 104 weeks.
clinical laboratory assessments.
Time frame: 104 weeks.
vital signs.
Time frame: 104 weeks.
physical examination
Time frame: 104 weeks
ECG.
Time frame: 104 weeks.
To evaluate whether EVER001 can modulate proteinuria in pMN.
Percentage change from baseline of 24 hr proteinuria throughout 52 weeks.
Time frame: 52 weeks.
To evaluate whether EVER001 can modulate anti-PLA2R autoantibodies in patients with positive baseline levels of these antibodies.
Percentage change from baseline of anti-PLA2R autoantibody level throughout 52 weeks.
Time frame: 52 weeks.
To evaluate the clinical response and immunological response in pMN.
To evaluate the clinical response and immunological response in pMN.
Time frame: 104 weeks.
Maximum Observed Plasma Concentration (Cmax) of EVER001
Time frame: 52 weeks.
Minimum Observed Plasma Concentration (Cmin) of EVER001
Time frame: 52 weeks.
Time to Reach Maximum Observed Concentration (Tmax) of EVER001.
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Time frame: 52 weeks.