Safety Evaluation Study for Patients With Polycythemia Vera

Phase 1

Recruiting

• Conditions: Polycythemia Vera
• Interventions: Drug: PPMX-T003

• Registration Number: NCT05074550
• Lead Sponsor: Perseus Proteomics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-12
• Study Start: 2022-08-24
• Status Verified: 2022-11
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Primary Completion: 2023-08-01
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PPMX-T003	PPMX-T003	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the Study	45 weeks

Secondary Outcome Measures

Name	Time	Method
Evaluation of pharmacokinetics of PPMX-T003 after single dose	Day1,Day2,Day7	Volume of distribution \[Vd\]
Examining the expression rate of anti-drug antibodies (ADA)	Day1,Day21,up to 45weeks

Trial Locations

Locations (3)

Kansai Medical University Hospital; 🇯🇵 Hirakata, Osaka, Japan

Shimane University Hospital; 🇯🇵 Izumo, Shimane, Japan

Osaka City University Hospital; 🇯🇵 Osaka, Japan