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

January 9, 2025 updated by: JW Pharmaceutical

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital Clinical Trial Center
        • Contact:
          • SeungHwan Lee
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy Korean or Caucasian volunteers

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group (JW2286)
Ethnicity: Korean or Caucasian
Drug: JW2286
a single administration of JW2286 per dose
Placebo Comparator: Placebo group (Placebo of JW2286)
Ethnicity: Korean or Caucasian
Drug: Placebo of JW2286
a single administration of Placebo of JW2286 per dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286
Time Frame: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
0 to 168 hours
Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) of JW2286
Time Frame: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
0 to 168 hours
The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286
Time Frame: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
0 to 168 hours
Time of Maximum Concentration (Tmax) of JW2286
Time Frame: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
0 to 168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: SeungHwan Lee, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • JW23104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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