Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001

• Status: Not yet recruiting
• Trial end date: 2026-04-15
• Target enrollment: 0
• Participant gender: All

Summary

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 is primary membranous nephropathy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Everest Medicines (China) Co.,Ltd.

Criteria

Inclusion Criteria:

1. Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.

2. Have positive anti-PLA2R autoantibody test results > 20 relative units (RU)/ml AND < 150RU/ml at screening.

3. During screening at least one testing of proteinuria must be >3.5 g/24h.

4. Have nephrotic range proteinuria for at least 3 months prior to Day 1 and no improvement despite supportive therapy of ACE inhibitor or ARB unless contraindicated.

Exclusion Criteria:

1. Non-primary membranous nephropathy or other condition affecting the kidney.

2. eGFR at screening < 60 mL/min/1.73m2 or kidney function not stable .

3. Uncontrolled hypertension .

4. Serum albumin level at screening ≤ 25g/l.

5. Have received: B-cell targeted therapy except rituximab at any time; Rituximab and the biosimilars within 2 years (participants with rituximab treatment between 1 and 2 years prior to Day 1 are eligible if there is documented evidence of B-cell repopulation to >90% of Lower Limits of Normal Range.); Cyclophosphamide or Chlorambucil within 180 days; immunosuppressive/immunomodulatory agents within 90 days.

6. Acute or chronic infection.

7. Positive serology for HIV, HBV, or HCV.

8. Lab testing abnormality as: WBC< 3000/mm³, Lymphocyte < 1000/mm³, neutrophil <1500/mm³, Hb < 80g/L, Platelet count <100×10e9/L, Prothrombin time>1.5×ULN, Activated partial thromboplastin time ≥ 1.5×ULN.

9. Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.