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| Name | Class |
|---|---|
| YUNOVIA CO.,LTD. | UNKNOWN |
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) |
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| Cohort 2 | Experimental | Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) |
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| Cohort 3 | Experimental | Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID110521156 | Drug | ID110521156 capsules taken orally once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| AEs/serious AEs (SAEs) | Throughout study duration, up to 47 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of drug in plasma (Cmax) | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. | Day 1 and Day 28 |
| Area under the plasma drug concentration-time curve during a dosing interval (AUCtau) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Ops Study Leader | Contact | +82-10-4570-1405 | eh.hong@yunovia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Placebo of 110521156 | Drug | ID110521156 placebo capsules taken orally once daily |
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To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| Day 1 and Day 28 |
| The time of peak concentration (Tmax) | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. | Day 1 and Day 28 |
| Terminal half-life (t1/2) | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. | Day 1 and Day 28 |
| Apparent clearance (CL/F) | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. | Day 1 and Day 28 |
| Apparent volume of distribution after extravascular administration (Vd/F) | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. | Day 1 and Day 28 |
| Renal clearance (CLR) | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. | Day 1 and Day 28 |
| fe | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. | Day 1 and Day 28 |
| Trough plasma concentration taken directly before the next dose (Ctrough) | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. | Throughout study duration, up to 27 days |
| Minimum concentration of drug in plasma at steady state (Cmin, ss) | To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants. | Day 28 |
| Average concentration of drug in plasma at steady state (Cavg, ss) | To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants. | Day 28 |
| peak to trough fluctuation (PTF) | To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants. | Day 28 |
| accumulation ratio (R) | To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants. | Day 28 |
| Serum glucose | To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants. | up to 28 days |
| Insulin | To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants. | up to 28 days |
| Hemoglobin A1c (HbA1c) | To assess the pharmacodynamics of ID110521156 when given at multiple ascending doses in healthy participants. | up to 47 days |