Safety Evaluation Study for Patients With Polycythemia Vera

Perseus Proteomics

Status and phase: Enrolling; Phase 1

Conditions: Polycythemia Vera

Treatments: Drug: PPMX-T003

Study type: Interventional

Funder types: Industry

Identifiers

NCT05074550

PPMX-T003-CT102

Details and patient eligibility

About

This is PhaseI Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of PPMX-T003 in Polycythemia Vera

Enrollment: 6 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of PV according to either the 2008 or 2016 WHO classification criteria
• PV patients being only treated with phlebotomy and the interval is 4-9 weeks

Exclusion criteria

• Patients administrated drugs for PV treatment such as hydroxyurea or ruxolitinib (aspirin is excluded)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 1 patient group

PPMX-T003

Experimental group

Description:

This drug should be administered within 48 hours after the phlebotomy. In addition, as a dose escalation design, 4 doses of 0.25 mg/kg, 0.4 mg/kg, 0.64 mg/kg, and 1 mg/kg are administered to the same subject, when the next phlebotomy required during observation period after the 1st administration.

Treatment:

Drug: PPMX-T003