Actively Recruiting

Phase 1
Age: 19Years - 50Years
All Genders
Healthy Volunteers
ID06703710

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JW2286 After a Single Oral Dose Exploring Food Effect and Ethnic Differences in Healthy Korean and Caucasian Adults

Led by JW Pharmaceutical · Updated on 2025-01-13

72

Participants Needed

1

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the safety, tolerability, and how the body processes a drug called JW2286 in healthy adult volunteers. It is a phase 1 clinical trial designed to also explore how food intake and ethnic background might affect the drug's behavior in the body. The study uses a randomized, double-blind, placebo-controlled approach with single ascending doses of JW2286. Participants will receive a single oral dose of JW2286 or a matching placebo. The trial involves administering one dose at a time with increasing amounts to assess safety and drug levels. The study compares the drug's pharmacokinetic characteristics in healthy Korean and Caucasian adults, monitoring how the drug concentration changes over time. During the study, participants will undergo evaluations to measure drug levels in their blood over a period of up to 168 hours after dosing. Researchers will assess the peak concentration, total exposure, and timing of the drug in the body. Safety and tolerability will be closely monitored throughout the study period, which includes follow-up to observe any side effects or reactions.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy Korean or Caucasian volunteers
Not Eligible

You will not qualify if you...

  • Individuals with a clinically significant disease or history
  • Individuals with a history of a gastrointestinal disorder or surgery
  • Female individuals with childbearing potential, except those who are surgically sterile

AI-Screening

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Actively Recruiting

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Research Team

H

Hyeona Kim

S

Soojin Park

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

OTHER

Number of Arms

2

Frequently Asked Questions

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Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JW2286 After a Single Oral Dose Exploring Food Effect and Ethnic Differences in Healthy Korean and Caucasian Adults | DecenTrialz