RecruitingPhase 1NCT06703710

To Evaluate the Safety/Tolerability and Pharmacokinetic Characteristics in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and PK Characteristics, and to Explore Food Effect and Ethnic Difference of JW2286 in Healthy Volunteers


Sponsor

JW Pharmaceutical

Enrollment

72 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics, and to explore food effect and ethnic difference of JW2286 after oral administration in healthy adults.


Eligibility

Min Age: 19 YearsMax Age: 50 Years

Inclusion Criteria1

  • Healthy Korean or Caucasian volunteers

Exclusion Criteria3

  • Individuals with a clinically significant disease or history
  • Individuals with a history of a gastrointestinal disorder or surgery
  • In the case of all female individuals with childbearing potential, except for those who are surgically sterile

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Interventions

DRUGJW2286

a single administration of JW2286 per dose

DRUGPlacebo of JW2286

a single administration of Placebo of JW2286 per dose


Locations(1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

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NCT06703710


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