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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single administration of low dose NPC-22 |
|
| 2 | Experimental | Single administration of low/middle dose NPC-22 |
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| 3 | Experimental | Single administration of middle dose NPC-22 |
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| 4 | Experimental | Single administration of middle/high dose NPC-22 |
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| 5 | Experimental | Single administration of high dose NPC-22 |
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| 6 | Experimental | Single administration of placebo dose NPC-22 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPC-22 | Drug | Single administration of low dose NPC-22 |
| |
| NPC-22 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-7 days post dose |
| Body temperature | Body temperature will be measured for assess the safety of single ascending dose of NPC-22 | 0-7 days post dose |
| Blood pressure | Blood pressure will be measured for assess the safety of single ascending dose of NPC-22 | 0-7 days post dose |
| Pulse rate | Pulse rate will be measured for assess the safety of single ascending dose of NPC-22 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Observed plasma concentration | 0-7 days post dose | |
| Observed urine concentration | 0-4 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Shinanokai Shinanozaka Clinic | Shinjuku | Tokyo | 160-0017 | Japan |
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| Drug |
Single administration of low/middle dose NPC-22 |
|
| NPC-22 | Drug | Single administration of middle dose NPC-22 |
|
| NPC-22 | Drug | Single administration of middle/high dose NPC-22 |
|
| NPC-22 | Drug | Single administration of high dose NPC-22 |
|
| NPC-22 Placebo | Drug | Single administration of NPC-22 Placebo |
|
| 0-7 days post dose |
| Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis | Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22 | 0-7 days post dose |