Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| YUNOVIA CO.,LTD. | UNKNOWN |
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of ID110521156 in healthy adult subjects. This is the first clinical study of ID110521156.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. |
|
| Cohort 2 | Experimental | Cohort 2 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. |
|
| Cohort 3 | Experimental | Cohort 3 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. |
|
| Cohort 4 | Experimental | Cohort 4 will consist of 12 healthy subjects who will receive a single oral dose of ID110521156 at fed state and fasted state each. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID110521156 | Drug | subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs/serious AEs (SAEs) | Incidence and severity of ad adverse event | Throughout study duration, up to 9 days |
| Percentage of subjects with clinically significant change from baseline in vital signs, ECG, safety laboratory test results | Throughout study duration, up to 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days |
| Area under the plasma drug concentration-time curve from 0 to last, (AUClast) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo of ID110521156 | Drug | subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1 |
|
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
| Throughout study duration, up to 9 days |
| Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days |
| The time of peak concentration,(Tmax) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days |
| Terminal half-life (T1/2) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days |
| Apparent clearance (CL/F) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days |
| Apparent volume of distribution after extravascular administration (Vd/F) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days |
| Amount excreted in urine (Ae) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days |
| Renal Clearance (CLr) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days |
| Fraction excreted unchanged of an administered dose (fe) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days |