Evaluating the safety and effects of JW2286 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
This study is testing a new drug called JW2286 in healthy adults to see if it's safe and how it works in different people after they eat.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 19 Years to 50 Years |
| Sex | All |
| Sponsor | JW Pharmaceutical Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06703710 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to assess the safety and tolerability of JW2286 in healthy adults. It aims to evaluate the pharmacokinetic characteristics of the drug and explore the effects of food and ethnic differences on its absorption and metabolism. The study will involve healthy Korean and Caucasian volunteers, who will receive either the drug or a placebo. The trial is in Phase 1, focusing on initial safety assessments.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy Korean or Caucasian adults without significant medical histories.
Not a fit: Patients with clinically significant diseases, gastrointestinal disorders, or those who are pregnant or may become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and pharmacokinetics of JW2286, potentially leading to its future use in treating various conditions.
How similar studies have performed: Other studies evaluating the safety and pharmacokinetics of new drugs in healthy volunteers have shown success, making this approach a standard practice in early-phase drug development.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Seoul National University Hospital Clinical Trial Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: SeungHwan Lee — Seoul National University Hospital
- Study coordinator: Hyeona Kim
- Email: hyeona.kim@jwhealthcare.com
- Phone: +82-840-6791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.