Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera

Summary

This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design planning to enroll patients with polycythemia vera who are resistant/intolerant to hydroxyurea or interferon。The study divided into two stages: dose exploration stage: three dose groups are tentatively set, with three subjects in each group, totaling nine subjects in each group; Dose extension stage: Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage, 2-3 dose groups are planned to be selected for dose extension trials.

Timeline

Start

2025-09-23

Primary completion

2027-07-30

Completion

2028-02-28

Drugs

Indications