This is PhaseI Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of PPMX-T003 in Polycythemia Vera
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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.
Kansai Medical University Hospital
Hirakata, Osaka, Japan
RECRUITINGShimane University Hospital
Izumo, Shimane, Japan
RECRUITINGOsaka City University Hospital
Osaka, Japan
RECRUITINGNumber of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the Study
Time frame: 45 weeks
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Observed maximum plasma concentration \[Cmax\]
Time frame: Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Terminal elimination rate constant \[λz\]
Time frame: Day1,Day2,Day7
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 \[AUC0-t\]
Time frame: Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Area under the concentration-time curve from pre-dose \[time 0\] extrapolated to infinite time \[AUC0-inf\]
Time frame: Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Apparent terminal half-life \[t½\]
Time frame: Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Apparent systemic clearance \[CL\]
Time frame: Day1,Day2,Day7
Evaluation of pharmacokinetics of PPMX-T003 after single dose
Volume of distribution \[Vd\]
Time frame: Day1,Day2,Day7
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Examining the expression rate of anti-drug antibodies (ADA)
Time frame: Day1,Day21,up to 45weeks