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The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-G11 | Experimental | CT-G11 Experimental Drug |
|
| CT-G20 | Experimental | CT-G20 Experimental Drug |
|
| CT-G11 Placebo | Placebo Comparator |
| |
| CT-G20 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-G11 | Drug | oral tablet of CT-G11 Experimental Drug |
| |
| CT-G20 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events including serious Adverse events (Part I, Part II) | 46 days | |
| Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III) | Up to 48 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters as assessed by: QT interval of ECG | 17 Days | |
| Safety parameters as assessed by: QTcF of ECG | 17 Days | |
| Safety parameters as assessed by: blood pressure of Vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Jin Jang | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| Drug |
oral tablet of CT-G20 Experimental Drug |
|
| CT-G11 Placebo | Drug | oral tablet of Placebo |
|
| CT-G20 Placebo | Drug | oral tablet of Placebo |
|
| 17 Days |
| Safety parameters as assessed by: pulse rate of Vital signs | 17 Days |
| Safety parameters as assessed by: body temperature of Vital signs | 17 Days |
| Safety parameters as assessed by: hematology of Clinical laboratory tests | 17 Days |
| Safety parameters as assessed by: clinical chemistry | 17 Days |
| PK parameters as assessed by : Area under the concentration-time curve (AUC) | 13 Days |
| PK parameters as assessed by : Maximum observed concentration (Cmax) | 13 Days |
| PK parameters as assessed by : Time to Cmax (tmax) | 13 Days |
| PK parameters as assessed by : Terminal half-life time (t1/2) | 13 Days |
| PD parameters as assessed by : Left ventricular ejection fraction (LVEF) | 17 Days |