Polycythemia Vera
Conditions
Keywords
Myeloproliferative neoplasms
Brief summary
This is PhaseI Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of PPMX-T003 in Polycythemia Vera
Interventions
DRUGPPMX-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.
Sponsors
Perseus Proteomics Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the Study | 45 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pharmacokinetics of PPMX-T003 after single dose | Day1,Day2,Day7 | Observed maximum plasma concentration \[Cmax\] |
| Examining the expression rate of anti-drug antibodies (ADA) | Day1,Day21,up to 45weeks | — |
Countries
Japan
Contacts
Primary ContactTadashi Matsuura
Backup ContactHiroko Akiyoshi
Outcome results
None listed