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Recruiting

NCT Number: NCT06703710

To Evaluate the Safety/Tolerability and Pharmacokinetic Characteristics 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.

Recruiting

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Location status: Recruiting

Location contact

Jaegu Kang

CONTACT

[email protected]

+82-2072-1666

SeungHwan Lee

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JW2286

Drug

a single administration of JW2286 per dose

Placebo of JW2286

Drug

a single administration of Placebo of JW2286 per dose

Primary outcomes

  1. Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286

    Time frame: 0 to 168 hours

    Pharmacokinetic Characteristics Evaluation

  2. Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) of JW2286

    Time frame: 0 to 168 hours

    Pharmacokinetic Characteristics Evaluation

  3. The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286

    Time frame: 0 to 168 hours

    Pharmacokinetic Characteristics Evaluation

  4. Time of Maximum Concentration (Tmax) of JW2286

    Time frame: 0 to 168 hours

    Pharmacokinetic Characteristics Evaluation

Study contacts

Contact information is provided by the study sponsor or research team.

Hyeona Kim

CONTACT

[email protected]

+82-840-6791

Soojin Park

CONTACT

[email protected]

+82-2-840-6166

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 25, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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