Status:

COMPLETED

Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

Lead Sponsor:

JW Pharmaceutical

Conditions:

Healthy

Eligibility:

All Genders

19-55 years

Phase:

PHASE1

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 produc...

Eligibility Criteria

Inclusion

  • \- 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

  • \- Subjects judged by the investigators unsuitable for participating in the study based on any other reasons

Key Trial Info

Start Date :

February 15 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 15 2019

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT04018170

Start Date

February 15 2019

End Date

December 15 2019

Last Update

February 13 2020

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Severance Hospital

Seoul, South Korea, 06725

2

Seoul National University Hospital

Seoul, South Korea