Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is conducted to evaluate the safety/tolerability and PK/PD of JW1601 after oral administration in healthy Korean, Caucasian and Japanese adult volunteers

Detailed Description
-----------------
This is a dose block-randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and PK/PD profile by administering investigational product (IP) as a single dose (One time) or repeated doses (7 days, once a day) orally in a fasted state.

Official Title
-----------------
A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase I Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of JW1601

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Study drug
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects who have voluntarily given written informed consent to participate in the study and comply with all study requirements after getting detailed explanation and full understanding of the study Exclusion Criteria: - Subjects judged by the investigators unsuitable for participating in the study based on any other reasons

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JW1601<br>tablet formulation | Drug: Study drug<br>* oral administration, once daily. The doses will be ascending per cohort from 10 mg to 600 mg<br>* Other names: JW1601;|
| Placebo Comparator: Placebo<br>tablet formulation identified with JW1601 | Drug: Placebo<br>* oral administration, once daily. The matching placebo doses will be ascending per cohort from 1 to 4 tablets<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability after single ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring | AE incidence and the value or the change from baseline such as vital signs, 12-lead ECG, and clinical laboratory tests will be compared by each group and placebo group. | From Day 1 through Post Study Visit (Day 8) | 
| Safety and tolerability in multiple ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring | AE incidence and the value or the change from baseline such as vital signs, 12-lead ECG, and clinical laboratory tests will be compared by each group and placebo group. | From Day 1 through Post Study Visit (Day 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax in plasma in single ascending dose administration | Maximum concentration of drug in plasma | Baseline(Day 1) through Day 4 | 
| Tmax in plasma in single ascending dose administration | Time to maximum plasma concentration | Baseline(Day 1) through Day 4 | 
| AUClast in plasma in single ascending dose administration | Area under the plasma drug concentration-time curve to last measurement | Baseline(Day 1) through Day 4 | 
| Eosinophil shape change(%) in single ascending dose administration | Imetit-induced eosinophil shape change | Baseline(Day -1) through Day 4 | 
| QT/QTc changes in single ascending dose administration | 12-lead ECG | Baseline(Day -1), Day 1, Day 2 | 
| C(max, ss) in plasma in multiple ascending dose administration | Maximum concentration of drug in plasma (at steady state) | Baseline(Day 1) through Day 10 | 
| T(max,ss) in plasma in multiple ascending dose administration | Time to maximum plasma concentration (at steady state) | Baseline(Day 1) through Day 10 | 
| AUC(τ,ss) in plasma in multiple ascending dose administration | Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state | Baseline(Day 1) through Day 10 | 
| Eosinophil shape change(%) in multiple ascending dose administration | Imetit-induced eosinophil shape change | Baseline(Day -1) through Day 10 | 
| QT/QTc changes in multiple ascending dose administration | 12-lead ECG | Baseline(Day -1), Day 7, Day 8 |