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This clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics, and to explore food effect and ethnic difference of JW2286 after oral administration in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group (JW2286) | Experimental | Ethnicity: Korean or Caucasian |
|
| Placebo group (Placebo of JW2286) | Placebo Comparator | Ethnicity: Korean or Caucasian |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JW2286 | Drug | a single administration of JW2286 per dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286 | Pharmacokinetic Characteristics Evaluation | 0 to 168 hours |
| Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) of JW2286 | Pharmacokinetic Characteristics Evaluation | 0 to 168 hours |
| The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286 | Pharmacokinetic Characteristics Evaluation | 0 to 168 hours |
| Time of Maximum Concentration (Tmax) of JW2286 | Pharmacokinetic Characteristics Evaluation | 0 to 168 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyeona Kim | Contact | +82-840-6791 | hyeona.kim@jwhealthcare.com | |
| Soojin Park | Contact | +82-2-840-6166 | park.soojin@jwhealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| SeungHwan Lee | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Recruiting | Seoul | South Korea |
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| Placebo of JW2286 |
| Drug |
a single administration of Placebo of JW2286 per dose |
|