Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Study drug; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 06725
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Minsoo Park, MD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: JWP-FRC-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No