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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test group (JW2286)

Ethnicity: Korean or Caucasian

Group Type EXPERIMENTAL

JW2286

Intervention Type DRUG

a single administration of JW2286 per dose

Placebo group (Placebo of JW2286)

Ethnicity: Korean or Caucasian

Group Type PLACEBO_COMPARATOR

Placebo of JW2286

Intervention Type DRUG

a single administration of Placebo of JW2286 per dose

Interventions

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JW2286

a single administration of JW2286 per dose

Intervention Type DRUG

Placebo of JW2286

a single administration of Placebo of JW2286 per dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes