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The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending dose, MT-8554 or Placebo | Experimental |
| |
| Multiple ascending dose, MT-8554 or Placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-8554 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as measured by vital signs | up to Day14 | |
| Safety and Tolerability as measured by ECG | up to Day14 | |
| Safety and Tolerability as measured by continuous lead II ECG monitoring | up to Day14 | |
| Safety and Tolerability as measured by laboratory safety assessments | up to Day14 | |
| Safety and Tolerability as measured by physical examination | up to Day14 | |
| Safety and Tolerability as measured by number of participants with adverse events | up to Day14 |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile (Cmax, tmax, t½, AUC) | Cmax, tmax, t½, AUC | 240 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational center | City Name | United Kingdom |
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| Drug |
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