The purpose of this study is to examine the safety and pharmacokinetics of high dose NPC-22 administration in healthy adult males. The effect of administration routes for pharmacokinetics will be examined in advance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
32
Single administration of middle dose NPC-22
Single administration of high dose NPC-22
Single administration of NPC-22 Placebo
Medical Corporation Shinanokai Shinanozaka Clinic
Shinjuku-Ku, Tokyo, Japan
Adverse events
An adverse event will refer to any unfavorable or unintended sign (including an abnormal laboratory finding and abnormality on the 12-lead ECG or in vital signs) and symptom
Time frame: 0-14 days post dose
Body temperature
Body temperature will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Blood pressure
Blood pressure will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Pulse rate
Pulse rate will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
ECG
RR, PR, QRS, QT and QTcF interval and heart rate will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Number and/or rates of subjects with treatment-related adverse events as assessed by hematology tests
Hematology tests will be performed for assessment the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Number and/or rates of subjects with treatment-related adverse events as assessed by blood chemistry tests
Blood chemistry tests will be performed for assessment the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis
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Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Observed plasma concentration
Time frame: 0-14 days post dose
Observed urine concentration
Time frame: 0-14 days post dose