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Completed

NCT Number: NCT04018170

Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

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

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital, Seoul, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study Drug

Drug

oral administration, once daily. The doses will be ascending per cohort from 10 mg to 600 mg

Other names: JW1601

Placebo

Drug

oral administration, once daily. The matching placebo doses will be ascending per cohort from 1 to 4 tablets

Primary outcomes

  1. Safety and tolerability after single ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring

    Time frame: 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.

  2. Safety and tolerability in multiple ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring

    Time frame: 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 outcomes

  1. Cmax in plasma in single ascending dose administration

    Time frame: Baseline(Day 1) through Day 4

    Maximum concentration of drug in plasma

  2. Tmax in plasma in single ascending dose administration

    Time frame: Baseline(Day 1) through Day 4

    Time to maximum plasma concentration

  3. AUClast in plasma in single ascending dose administration

    Time frame: Baseline(Day 1) through Day 4

    Area under the plasma drug concentration-time curve to last measurement

  4. Eosinophil shape change(%) in single ascending dose administration

    Time frame: Baseline(Day -1) through Day 4

    Imetit-induced eosinophil shape change

  5. QT/QTc changes in single ascending dose administration

    Time frame: Baseline(Day -1), Day 1, Day 2

    12-lead ECG

  6. C(max, ss) in plasma in multiple ascending dose administration

    Time frame: Baseline(Day 1) through Day 10

    Maximum concentration of drug in plasma (at steady state)

  7. T(max,ss) in plasma in multiple ascending dose administration

    Time frame: Baseline(Day 1) through Day 10

    Time to maximum plasma concentration (at steady state)

  8. AUC(τ,ss) in plasma in multiple ascending dose administration

    Time frame: Baseline(Day 1) through Day 10

    Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state

  9. Eosinophil shape change(%) in multiple ascending dose administration

    Time frame: Baseline(Day -1) through Day 10

    Imetit-induced eosinophil shape change

  10. QT/QTc changes in multiple ascending dose administration

    Time frame: Baseline(Day -1), Day 7, Day 8

    12-lead ECG

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2019
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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