Health TrialsbyHealthPanel

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

ConditionPolycythemia Vera
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • BEBT-507 Injection

    Drug

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Phase Ia-Dose EscalationExperimental treatment 1 intervention
Group B: Phase Ib-Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MTD

Maximum Tolerated Dose

Time frame
Up to 52 weeks
2

DLT

Dose-Limiting Toxicity

Time frame
Up to 52 weeks
3

Proportion of Subjects With Hematocrit (HCT) < 45%

The proportion of subjects with HCT\<45% following at least 21 days without or with specified therapies (phlebotomy or erythrocytapheresis).

Time frame
Up to 100 weeks

Secondary outcomes

1

AUC0-∞

The area under the plasma concentration-time curve from time zero to infinity.

Time frame
Pre-dose to 168h post-dose on day 1; Pre-dose to 168h post-dose on day 85 (day 85±3 days).
2

AUC0-last

The area under the plasma concentration-time curve from administration to the last measurable concentration time point.

Time frame
Pre-dose to 168h post-dose on day 1; Pre-dose to 168h post-dose on day 85 (day 85±3 days).
3

Cmax

The maximum plasma drug concentration

Time frame
Pre-dose to 168h post-dose on day 1; Pre-dose to 168h post-dose on day 85 (day 85±3 days).
4

Tmax

The time to reach maximum plasma drug concentration

Time frame
Pre-dose to 168h post-dose on day 1; Pre-dose to 168h post-dose on day 85 (day 85±3 days).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeBetter Med Inc

Lead sponsor

Source ClinicalTrials.gov
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