Menu
Recruiting NCT06703710

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

Phase I Interventional Healthy

For patients and families

In plain language

Fill the application

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JW2286, Placebo of JW2286.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 19 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug JW2286
    a single administration of JW2286 per dose
  • Drug Placebo of JW2286
    a single administration of Placebo of JW2286 per dose

Primary outcome measures

  • Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286 [Time frame: 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]
  • The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286 [Time frame: 0 to 168 hours]
  • Time of Maximum Concentration (Tmax) of JW2286 [Time frame: 0 to 168 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Other

Study locations

South Korea · 1 center
  • Seoul National University Hospital Clinical Trial Center — Seoul

Identifiers

NCT: NCT06703710 · JW23104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗