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Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

Sponsor
JW Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT04018170
Collaborator
(none)
102
Enrollment
2
Locations
2
Arms
10
Actual Duration (Months)
51
Patients Per Site
5.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Study drug
  • Drug: Placebo
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 15, 2019
Actual Primary Completion Date :
Dec 15, 2019
Actual Study Completion Date :
Dec 15, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. Cmax in plasma in single ascending dose administration [Baseline(Day 1) through Day 4]

      Maximum concentration of drug in plasma

    2. Tmax in plasma in single ascending dose administration [Baseline(Day 1) through Day 4]

      Time to maximum plasma concentration

    3. 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

    4. Eosinophil shape change(%) in single ascending dose administration [Baseline(Day -1) through Day 4]

      Imetit-induced eosinophil shape change

    5. QT/QTc changes in single ascending dose administration [Baseline(Day -1), Day 1, Day 2]

      12-lead ECG

    6. 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)

    7. T(max,ss) in plasma in multiple ascending dose administration [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 [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 [Baseline(Day -1) through Day 10]

      Imetit-induced eosinophil shape change

    10. QT/QTc changes in multiple ascending dose administration [Baseline(Day -1), Day 7, Day 8]

      12-lead ECG

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Korea, Republic of 06725
    2 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • JW Pharmaceutical

    Investigators

    • Principal Investigator: Minsoo Park, MD, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JW Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT04018170
    Other Study ID Numbers:
    • JWP-FRC-101
    First Posted:
    Jul 12, 2019
    Last Update Posted:
    Feb 13, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 13, 2020