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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: JW2286; Drug: Placebo of JW2286

• Registration Number: NCT06703710
• Lead Sponsor: JW Pharmaceutical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-25
• Status Verified: 2025-01
• Study Start: 2025-01-06
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-11
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Test group (JW2286)	JW2286	Ethnicity: Korean or Caucasian
Placebo group (Placebo of JW2286)	Placebo of JW2286	Ethnicity: Korean or Caucasian

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of