Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Study drug; Drug: Placebo

• Registration Number: NCT04018170
• Lead Sponsor: JW Pharmaceutical

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.

Study Timeline

• Study Start: 2019-02-15
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JW1601	Study drug	tablet formulation
Placebo	Placebo	tablet formulation identified with JW1601

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cmax in plasma in single ascending dose administration	Baseline(Day 1) through Day 4	Maximum concentration of drug in plasma
Tmax in plasma in single ascending dose administration	Baseline(Day 1) through Day 4	Time to maximum plasma concentration
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
Eosinophil shape change(%) in single ascending dose administration	Baseline(Day -1) through Day 4	Imetit-induced eosinophil shape change
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)
T(max,ss) in plasma in multiple ascending dose administration	Baseline(Day 1) through Day 10	Time to maximum plasma concentration (at steady state)
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

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of