drugset / Trial / NCT07012109
Study of BEBT-507 Injection in Subjects With Polycythemia Vera (PV)
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multicenter, open-label Phase I clinical trial of BEBT-507 in subjects with polycythemia vera(PV). Phase Ia is a single-agent dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics of BEBT-507 in subjects with PV . Based on the results of Phase Ia, two doses will be selected for further evaluation in Phase Ib to assess the efficacy, safety, and PK profile of BEBT-507 in subjects with PV , and to recommend a dose for Phase III clinical trials.
Timeline
- Start
- 2025-06-05
- Primary completion
- 2028-01-31
- Completion
- 2028-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BEBT-507 | Unknown | 1.25 mg/kg | Subcutaneous |
| Subject | BEBT-507 | Unknown | 2.5 mg/kg | Subcutaneous |
| Subject | BEBT-507 | Unknown | 5 mg/kg | Subcutaneous |
| Subject | BEBT-507 | Unknown | 10 mg/kg | Subcutaneous |
| Subject | BEBT-507 | Unknown | 15 mg/kg | Subcutaneous |