NCT05800873 Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001
| NCT ID | NCT05800873 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Everest Medicines (China) Co.,Ltd. |
| Condition | Primary Membranous Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-05-15 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-05-15 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 disease is primary membranous nephropathy.
Eligibility 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. 3. During screening at least one testing of proteinuria must be \>3.5 g/24h. 4. Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (\<50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g/24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required. Exclusion Criteria: 1. Non-primary membranous nephropathy or other condition affecting the kidney. 2. eGFR at screening \< 45 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;other immunosuppressive/immunomodulatory agents within 90 days;greater than 30mg/day prednisone or equivalence within 30 days. 6. Acute or chronic infection,including positivity of tuberculosis infection test. 7. Positive serology for TP,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, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5×ULN, alkaline phosphatase and bilirubin \>1.5×ULN. 9. Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05800873 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Membranous Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05800873 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05800873 currently recruiting?
Yes, NCT05800873 is actively recruiting participants. Contact the research team at lixia.wang@everestmedicines.com for enrollment information.
Where is the NCT05800873 trial being conducted?
This trial is being conducted at Changsha, China, Chongqing, China, Guangzhou, China, Shenzhen, China and 11 additional locations.
Who is sponsoring the NCT05800873 clinical trial?
NCT05800873 is sponsored by Everest Medicines (China) Co.,Ltd.. The trial plans to enroll 30 participants.