Comparing safety and how the body handles UIC202502 and UIC202505 in healthy adults.
A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Study to Evaluate the Pharmacokinetic Interaction and the Safety of UIC202502 and UIC202505 in Healthy Adult Volunteers
This trial will test whether UIC202502 and UIC202505, given alone or together, are safe and how they are processed by the body in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Korea United Pharm. Inc. Industry-sponsored |
| Locations | 1 site (Seoul, Gwanak-gu) |
| Trial ID | NCT07162441 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label, multiple-dose, two-intervention-group, single-sequence crossover trial enrolls healthy adult volunteers to compare the pharmacokinetics and safety of UIC202502 and UIC202505 when administered alone or in combination. Participants receive scheduled doses of each investigational product with within-subject crossover and serial blood sampling to measure drug concentrations and timing. Safety monitoring includes clinical exams and electrocardiograms alongside laboratory testing. The study is sponsored by Korea United Pharm. Inc. and conducted at H plus Yangji Hospital in Seoul.
Who should consider this trial
Good fit: Ideal participants are healthy adults aged 19 years or older, weighing >50 kg (≥45 kg for females) with BMI 18.0–30.0 kg/m², without clinically significant medical conditions and willing to use non-hormonal contraception and undergo ECGs and PK sampling.
Not a fit: People with active medical problems, pregnant or breastfeeding individuals, or patients seeking direct therapeutic benefit for dyslipidemia are unlikely to receive medical benefit from this Phase 1 healthy-volunteer study.
Why it matters
Potential benefit: If successful, the results could identify safe dosing and drug-drug interaction information to guide further development of these dyslipidemia treatments.
How similar studies have performed: Crossover pharmacokinetic interaction studies have commonly and successfully characterized interactions for other lipid agents, but these specific UIC compounds appear to be in early-phase development with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Subjects aged 19 years or older at the time of screening.
* Subjects with a body weight greater than 50 kg (≥45 kg for females) and a body mass index (BMI) between 18.0 and 30.0 kg/m² at screening.
(BMI (kg/m²) = weight (kg) / height (m)²)
* Subjects with no clinically significant congenital or chronic diseases, pathological symptoms or findings at screening.
* Subjects determined by the principal investigator to be suitable for diagnostic procedures and electrocardiogram assessments
* Subjects who agree to use an effective method of contraception (excluding hormonal agents) recognized as appropriate in clinical trials from the first administration of the investigational drug until 14 days after the last administration, together with their spouse or partner.
* Subjects who have provided written informed consent after receiving a full explanation and demonstrating an understanding of the purpose, procedures, and characteristics of this clinical trial and the investigational drug.
Exclusion Criteria:
* Subjects with clinically significant diseases or a history of conditions involving the digestive, cardiovascular, endocrine, respiratory, hematologic/oncologic infectious, renal/genitourinary, psychiatric/neurologic, musculoskeletal, immune, otorhinolaryngologic, dermatologic, or ophthalmologic systems.
* Subjects with a history of gastrointestinal surgery (excluding simple appendectomy or hernia repair) or gastrointestinal disease that may affect drug absorption.
* Subjects who have taken drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 1 month before the first dose, or drugs that may interfere with this clinical trial within 10 days before the first dose
* Subjects who have participated in another clinical trial or bioequivalence study and received an investigational drug within 6 months before the first administration.
* Subjects who have donated whole blood or blood components within 2 weeks, or received a blood transfusion within 4 weeks before the first administration.
* Subjects who meet any of the following criteria within 1 month before the first dose:
* Average alcohol consumption exceeding 21 drinks/week for men
* Average alcohol consumption exceeding 14 drinks/week for women
(1 drink = 50 mL soju, 30 mL liquor, or 250 mL beer)
* Smoking more than 20 cigarettes/day on average
* Subjects judged by the principal investigator to be unsuitable for participation in this clinical trial for any reason other than the above selection or exclusion criteria.
* Female subjects who are pregnant, suspected of being pregnant, or lactating
Where this trial is running
Seoul, Gwanak-gu
- H plus Yangji Hospital — Seoul, Gwanak-gu, South Korea (Recruiting)
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.