Study of BEBT-507 Injection in Subjects With Polycythemia Vera (PV)
ConditionPolycythemia Vera
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeBetter Med Inc
About this trial
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.
Eligibility criteria
Qualifiers
Male and female subjects aged 18-75 years (inclusive);
Subjects diagnosed with polycythemia vera (PV) according to the 2016 world health organization (WHO) criteria;
Disqualifiers
A history of intolerance to oligonucleotides, N-Acetylgalactosamine (GalNAc), or excipient components, or a history of intolerance to subcutaneous injections.
Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 12 weeks before screening.
Major bleeding event or blood transfusion for bleeding within 6 months before screening.
Meets the international working group for myeloproliferative neoplasms research and treatment criteria for post-PV myelofibrosis.
Trial design
Treatments tested in this trial
- BEBT-507 Injection
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov