The purpose of this trial is to examine the safety and pharmacokinetics of NPC-22 administered in a single ascending dose in healthy adult males.
The healthy adult males will be randomized into six arms, and will receive single dose of NPC-22 (five doses, placebo)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
40
Medical Corporation Shinanokai Shinanozaka Clinic
Shinjuku, 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: 0-7 days post dose
Body temperature
Body temperature will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-7 days post dose
Blood pressure
Blood pressure will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-7 days post dose
Pulse rate
Pulse rate will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-7 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: 0-7 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: 0-7 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: 0-7 days post dose
Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis
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Single administration of middle/high dose NPC-22
Single administration of high dose NPC-22
Single administration of NPC-22 Placebo
Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22
Time frame: 0-7 days post dose
Observed plasma concentration
Time frame: 0-7 days post dose
Observed urine concentration
Time frame: 0-4 days post dose