To Evaluate the Safety/Tolerability and Pharmacokinetic Characteristics in Healthy Volunteers
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-50
SponsorJW Pharmaceutical
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy Korean or Caucasian volunteers
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
JW2286
Druga single administration of JW2286 per dose
Placebo of JW2286
Druga single administration of Placebo of JW2286 per dose
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Test group (JW2286)Experimental treatment 1 intervention
Group B: Placebo group (Placebo of JW2286)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286
Pharmacokinetic Characteristics Evaluation
Time frame
0 to 168 hours2
Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) of JW2286
Pharmacokinetic Characteristics Evaluation
Time frame
0 to 168 hours3
The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286
Pharmacokinetic Characteristics Evaluation
Time frame
0 to 168 hours4
Time of Maximum Concentration (Tmax) of JW2286
Pharmacokinetic Characteristics Evaluation
Time frame
0 to 168 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov