Evaluating the safety and effects of JLP-2004 in healthy adults
A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004 in Healthy Adult Volunteers
This study is testing a new drug called JLP-2004 in healthy adults to see how safe it is and how it works in the body, including how food affects it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Jeil Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Chungju, Seowon-gu) |
| Trial ID | NCT06431399 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial is designed to assess the safety and pharmacokinetic characteristics of JLP-2004 in healthy adult volunteers. The study employs a randomized, open-label, crossover design, allowing participants to receive the treatment under different conditions, including the effect of food on drug absorption. Participants will undergo thorough medical evaluations to ensure they meet the eligibility criteria before administration of the drug. The trial aims to gather important data on how JLP-2004 behaves in the body and its safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adult volunteers aged 19 years or older, weighing more than 50 kg with a BMI between 18 and 30.
Not a fit: Patients with congenital or chronic diseases or those with significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and optimal administration of JLP-2004, potentially leading to its use in future therapeutic applications.
How similar studies have performed: While this specific approach is novel, similar studies evaluating pharmacokinetics and safety in healthy volunteers have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy adult volunteers aged 19 years or older at the time of screening 2. At the time of screening, those who weigh more than 50.0 kg and have a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less. 3. Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of internal medical examination (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography) 4. Those who be considered suitable for clinical subjects according to the results of laboratory tests (hematology tests, blood chemistry tests, urine tests, serum tests, blood coagulation tests, urine drugs tests), physical examinations and 12-lead electrocardiography at the time of screening 5. Those who voluntarily decide to participate and agree in writing to comply with the subject compliance requirements during the clinical trial period after receiving a detailed explanation of this clinical trial and fully understanding it Exclusion Criteria: 1. Those who have current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history. ① Renal impairment ② Liver disorder 2. For women, pregnant women (Urine-HCG positive) or breastfeeding mother 3. Those who have clinically significant hypersensitivity reactions such as asthma, hives, allergies, etc. to the main ingredient (Pelubiprofen), additives, or other drugs (aspirin or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)) and have a history of hypersensitivity reaction 4. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 5. Those with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs
Where this trial is running
Chungju, Seowon-gu
- Chungbuk National University Hospital — Chungju, Seowon-gu, South Korea (Recruiting)
Study contacts
- Principal investigator: Minkyu Park — Chungbuk National University Hospital
- Study coordinator: Dajin Kim
- Email: cbnuhkimdajin@cbnuh.or.kr
- Phone: 043-269-6781
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.