Safety Evaluation Study for Patients With Polycythemia Vera

July 21, 2023 updated by: Perseus Proteomics Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka City University Hospital
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
    • Shimane
      • Izumo, Shimane, Japan, 693-8501
        • Recruiting
        • Shimane University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the Study
Time Frame: 45 weeks
45 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Time Frame: Day1,Day2,Day7
Observed maximum plasma concentration [Cmax]
Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Time Frame: Day1,Day2,Day7
Terminal elimination rate constant [λz]
Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Time Frame: Day1,Day2,Day7
Area under the concentration-time curve from pre-dose [time 0] to the time of the last quantifiable concentration [AUC0-t]
Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Time Frame: Day1,Day2,Day7
Area under the concentration-time curve from pre-dose [time 0] extrapolated to infinite time [AUC0-inf]
Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Time Frame: Day1,Day2,Day7
Apparent terminal half-life [t½]
Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Time Frame: Day1,Day2,Day7
Apparent systemic clearance [CL]
Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Time Frame: Day1,Day2,Day7
Volume of distribution [Vd]
Day1,Day2,Day7
Examining the expression rate of anti-drug antibodies (ADA)
Time Frame: Day1,Day21,up to 45weeks
Day1,Day21,up to 45weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perseus Proteomics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2022

Primary Completion (Estimated)

August 1, 2023

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPMX-T003-CT102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycythemia Vera

Clinical Trials on PPMX-T003

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe