Safety Evaluation Study for Patients With Polycythemia Vera

Polycythemia Vera Clinical Trial

Official title:

Phase I, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of A Single Intravenous PPMX-T003 in Polycythemia Vera

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05074550
• Other study ID #: PPMX-T003-CT102
• Status: Recruiting
• Phase: Phase 1
• Start date: August 24, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2022
• Source: Perseus Proteomics Inc.
• Contact: Tadashi Matsuura
• Phone: +81-3-5738-1705
• Email: tmatsuura[@]ppmx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: March 31, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Polycythemia
• Polycythemia Vera

Intervention

Drug:
• PPMX-T003
As an observation and evaluation method, for each dose, in principle, inpatient observation is performed for 1 week from the day before administration, and then safety and pharmacodynamic tests are evaluated by visiting the hospital every 2 weeks.

Locations

Country	Name	City	State
Japan	Kansai Medical University Hospital	Hirakata	Osaka
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Osaka City University Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Perseus Proteomics Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the Study		45 weeks
Secondary	Evaluation of pharmacokinetics of PPMX-T003 after single dose	Observed maximum plasma concentration [Cmax]	Day1,Day2,Day7
Secondary	Evaluation of pharmacokinetics of PPMX-T003 after single dose	Terminal elimination rate constant [?z]	Day1,Day2,Day7
Secondary	Evaluation of pharmacokinetics of PPMX-T003 after single dose	Area under the concentration-time curve from pre-dose [time 0] to the time of the last quantifiable concentration [AUC0-t]	Day1,Day2,Day7
Secondary	Evaluation of pharmacokinetics of PPMX-T003 after single dose	Area under the concentration-time curve from pre-dose [time 0] extrapolated to infinite time [AUC0-inf]	Day1,Day2,Day7
Secondary	Evaluation of pharmacokinetics of PPMX-T003 after single dose	Apparent terminal half-life [t½]	Day1,Day2,Day7
Secondary	Evaluation of pharmacokinetics of PPMX-T003 after single dose	Apparent systemic clearance [CL]	Day1,Day2,Day7
Secondary	Evaluation of pharmacokinetics of PPMX-T003 after single dose	Volume of distribution [Vd]	Day1,Day2,Day7
Secondary	Examining the expression rate of anti-drug antibodies (ADA)		Day1,Day21,up to 45weeks