Safety Evaluation Study for Patients With Polycythemia Vera
- 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
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