NCT07012109

Study of BEBT-507 Injection in Subjects With Polycythemia Vera (PV)

A Multicenter, Open-Label Phase I Clinical Trial of BEBT-507 Injection in Subjects With Polycythemia Vera (PV)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: BeBetter Med Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase Ia Study:Phase Ia plans to set up 5 dose groups (Cohorts A1-A5), with 3-6 subjects planned for enrollment in each dose group. The 5 dose groups are 1.25 mg/kg, 2.5mg/kg, 5mg/kg, 10mg/kg, and 15mg/kg, respectively. Subcutaneous injection is administered every 12 weeks, for a total of 2 doses. A "3+3" dose-escalation design will be used. If no dose-limiting toxicity (DLT) is observed in Cohort A5, further dose escalation will be determined by investigators and sponsors based on PK and safety data. Additional dose groups can be added if necessary. Phase Ib Study:Based on the results of the Phase Ia study, two doses will be selected for the phase Ib study. Each dose cohort will enroll approximately 10-30 eligible subjects.

Conditions

• Polycythemia Vera

Interventions

Type	Name	Description
DRUG	BEBT-507 Injection	The initial dose of BEBT-507 injection is 1.25mg/kg, administered subcutaneously at 1.25mg/kg, 2.5mg/kg, 5mg/kg, 10mg/kg or 15mg/kg every 12 weeks for two doses in total.

Timeline

• Start date: 2025-06-05
• Primary completion: 2028-01-31
• Completion: 2028-07-31
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: China