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

NCT07012109 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-06-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • BeBetter Med Inc

    lead INDUSTRY

Principal Investigators

  • Zhijian Xiao, Ph.D · Blood Diseases Hospital, Chinese Academy of Medical Sciences

  • Hongyan Tong, Ph.D · Zhejiang University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2028-01-31
Completion
2028-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07012109 on ClinicalTrials.gov