Actively Recruiting
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JW2286 After a Single Oral Dose Exploring Food Effect and Ethnic Differences in Healthy Korean and Caucasian Adults
Led by JW Pharmaceutical · Updated on 2025-01-13
72
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, tolerability, and how the body processes a drug called JW2286 in healthy adult volunteers. It is a phase 1 clinical trial designed to also explore how food intake and ethnic background might affect the drug's behavior in the body. The study uses a randomized, double-blind, placebo-controlled approach with single ascending doses of JW2286. Participants will receive a single oral dose of JW2286 or a matching placebo. The trial involves administering one dose at a time with increasing amounts to assess safety and drug levels. The study compares the drug's pharmacokinetic characteristics in healthy Korean and Caucasian adults, monitoring how the drug concentration changes over time. During the study, participants will undergo evaluations to measure drug levels in their blood over a period of up to 168 hours after dosing. Researchers will assess the peak concentration, total exposure, and timing of the drug in the body. Safety and tolerability will be closely monitored throughout the study period, which includes follow-up to observe any side effects or reactions.
CONDITIONS
Official Title
To Evaluate the Safety/Tolerability and Pharmacokinetic Characteristics in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy Korean or Caucasian volunteers
You will not qualify if you...
- Individuals with a clinically significant disease or history
- Individuals with a history of a gastrointestinal disorder or surgery
- Female individuals with childbearing potential, except those who are surgically sterile
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea
Actively Recruiting
Research Team
H
Hyeona Kim
S
Soojin Park
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here