Healthy
Conditions
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.
Interventions
DRUGStudy drug
oral administration, once daily. The doses will be ascending per cohort from 10 mg to 600 mg
DRUGPlacebo
oral administration, once daily. The matching placebo doses will be ascending per cohort from 1 to 4 tablets
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability after single ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring | From Day 1 through Post Study Visit (Day 8) | 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. |
| Safety and tolerability in multiple ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring | From Day 1 through Post Study Visit (Day 14) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eosinophil shape change(%) in single ascending dose administration | Baseline(Day -1) through Day 4 | Imetit-induced eosinophil shape change |
| Cmax in plasma in single ascending dose administration | Baseline(Day 1) through Day 4 | Maximum concentration of drug in plasma |
| QT/QTc changes in single ascending dose administration | Baseline(Day -1), Day 1, Day 2 | 12-lead ECG |
| C(max, ss) in plasma in multiple ascending dose administration | Baseline(Day 1) through Day 10 | Maximum concentration of drug in plasma (at steady state) |
| Tmax in plasma in single ascending dose administration | Baseline(Day 1) through Day 4 | Time to maximum plasma concentration |
| AUC(τ,ss) in plasma in multiple ascending dose administration | Baseline(Day 1) through Day 10 | Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state |
| Eosinophil shape change(%) in multiple ascending dose administration | Baseline(Day -1) through Day 10 | Imetit-induced eosinophil shape change |
| QT/QTc changes in multiple ascending dose administration | Baseline(Day -1), Day 7, Day 8 | 12-lead ECG |
| T(max,ss) in plasma in multiple ascending dose administration | Baseline(Day 1) through Day 10 | Time to maximum plasma concentration (at steady state) |
| AUClast in plasma in single ascending dose administration | Baseline(Day 1) through Day 4 | Area under the plasma drug concentration-time curve to last measurement |
Countries
South Korea
Outcome results
None listed