To Evaluate the Safety/Tolerability and Pharmacokinetic Characteristics in Healthy Volunteers
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
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jan 2025
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
November 25, 2024
CompletedStudy Start
First participant enrolled
January 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedJanuary 13, 2025
January 1, 2025
10 months
November 18, 2024
January 9, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286
Pharmacokinetic Characteristics Evaluation
0 to 168 hours
Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) of JW2286
Pharmacokinetic Characteristics Evaluation
0 to 168 hours
The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286
Pharmacokinetic Characteristics Evaluation
0 to 168 hours
Time of Maximum Concentration (Tmax) of JW2286
Pharmacokinetic Characteristics Evaluation
0 to 168 hours
Study Arms (2)
Test group (JW2286)
EXPERIMENTALEthnicity: Korean or Caucasian
Placebo group (Placebo of JW2286)
PLACEBO COMPARATOREthnicity: Korean or Caucasian
Interventions
a single administration of Placebo of JW2286 per dose
Eligibility Criteria
You may qualify if:
- Healthy Korean or Caucasian volunteers
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
SeungHwan Lee
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2024
First Posted
November 25, 2024
Study Start
January 6, 2025
Primary Completion
November 1, 2025
Study Completion
January 1, 2026
Last Updated
January 13, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share