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| Name | Class |
|---|---|
| Aetas Pharma Co. Ltd. | INDUSTRY |
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This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple continuous intravenous injection in Healthy Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M201-A Injection | Experimental | Active Substance: M201-A Route of administration: continuous intravenous injection |
|
| Placebo | Placebo Comparator | Placebo: M201-A Placebo Route of administration: continuous intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M201-A Injection | Drug | Active Substance: M201-A Route of administration: continuous intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Number of participants with adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures. | Throughout the study duration up to day 11 |
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Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Department of Research, KITASATO UNIVERSITY KITASATO INSTITUTE HOSPITAL | Tokyo | 108-8642 | Japan |
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| Placebo | Drug | Placebo: M201-A Placebo Route of administration: continuous intravenous injection |
|