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| Name | Class |
|---|---|
| Aetas Pharma Co. Ltd. | INDUSTRY |
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This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single 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 | Saline Placebo for M201-A 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 | 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 day8) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-Cmax | Observed maximum plasma concentration (Cmax) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A |
| Pharmacokinetics-Tmax |
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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, Kitasato University Hospital, THE KITASATO INSTITUTE | Sagamihara | Kanagawa | 252-0375 | Japan |
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| Placebo | Drug | Saline Placebo for M201-A Route of administration: continuous intravenous injection |
|
Time to Cmax (Tmax) of M201-A
| Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A |
| Pharmacokinetics-AUC0-24 | Area under the plasma concentration-time curve from time zero to 24hour of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A |
| Pharmacokinetics-AUC0-t | -Area under the plasma concentration-time curve calculated from time zero to the last measured time point (AUC0-t) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A |
| Pharmacokinetics-AUC0-∞ | Area under the plasma concentration-time curve calculated from time zero to infinity (AUC0-∞) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A |
| Pharmacokinetics-t1/2 | Elimination half-life (t1/2) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A |
| Pharmacokinetics-CL | Apparent clearance of drug from plasma (CL) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A |
| Pharmacokinetics-Vd | Apparent volume of distribution during the terminal phase (Vd) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A |
| Pharmacokinetics-E0-24 | Amount of drug excreted in urine from time zero to 24hour of M201-A | up to 24 hours |
| Pharmacokinetics-Ae | Urinary excretion rate of M201-A | up to 24 hours |