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To determine the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability of MT921 in Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT921 60mg Group | Experimental | MT921 60 mg |
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| MT921 120mg Group | Experimental | MT921 120 mg |
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| MT921 150mg Group | Experimental | MT921 150 mg |
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| Placebo Group | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT921 | Drug | Formulated as an injectable solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) measured by Liquid Chromatography-mass spectrometry (LC/MS) | Peak plasma concentration measured by Liquid Chromatography-mass spectrometry (LC/MS) achieving in the test area of the body after administration. | Up to 24 hours |
| AUC0-24 | Area under the plasma concentration versus time curve from time 0 to 24 hours measured by Liquid Chromatography-mass spectrometry (LC/MS) after administration | Up to 24 hours |
| Maximum Time (Tmax) measured by Liquid Chromatography-mass spectrometry (LC/MS) | The time at which the Cmax is observed measured by Liquid Chromatography-mass spectrometry (LC/MS). | Up to 24 hours |
| Half-life (t1/2) measured by Liquid Chromatography-mass spectrometry (LC/MS) | The time it takes for the concentration of the drug in the plasma or the total amount in the body to be reduced by 50% measured by Liquid Chromatography-mass spectrometry (LC/MS). | Up to 24 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as assessed by MedDRA version 17.0 | Assessment of safety in investigational product with the number of participants with adverse events as assessed by MedDRA version 17.0. | Up to 21 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anam Hospital | Seoul | South Korea |
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| Placebo | Drug | normal saline |
|