Healthy
Conditions
Brief summary
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.
Interventions
DRUGJW2286
a single administration of JW2286 per dose
DRUGPlacebo of JW2286
a single administration of Placebo of JW2286 per dose
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Korean or Caucasian volunteers
Exclusion criteria
* Individuals with a clinically significant disease or history * Individuals with a history of a gastrointestinal disorder or surgery * In the case of all female individuals with childbearing potential, except for those who are surgically sterile
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of Maximum Concentration (Tmax) of JW2286 | 0 to 168 hours | Pharmacokinetic Characteristics Evaluation |
| Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286 | 0 to 168 hours | Pharmacokinetic Characteristics Evaluation |
| Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) of JW2286 | 0 to 168 hours | Pharmacokinetic Characteristics Evaluation |
| The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286 | 0 to 168 hours | Pharmacokinetic Characteristics Evaluation |
Countries
South Korea
Contacts
Primary ContactHyeona Kim
Backup ContactSoojin Park
Outcome results
None listed