A Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC2… (NCT07548957) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC202506, UIC202507 and UIC202508 in Healthy Adult Volunteers Under Fasting Conditions
South Korea44 participantsStarted 2026-04
Plain-language summary
This study was an open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the safety and pharmacokinetics of UI087 compared to coadministration of UIC202506, UIC202507 and UIC202508 in healthy adult volunteers under fasting conditions
Who can participate
Age range19 Years
SexALL
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Inclusion Criteria:
* Subjects aged 19 years or older at the screening visit
* Subjects with a body weight ≥ 50 kg (≥ 45 kg for females) and a body mass index (BMI) between 18.0 and 30.0 kg/m² at the screening visit
* BMI (kg/m²) = body weight (kg) / {height (m)}²
* Subjects without clinically significant congenital or chronic diseases and without pathological symptoms or findings based on medical examination at the screening visit
* Subjects deemed eligible for participation based on diagnostic tests (hematology, blood chemistry, serology, urinalysis, etc.) and ECG, as determined by the investigator (or delegated sub-investigator) according to the characteristics of the investigational product
* Subjects who agree to use medically acceptable contraception\* (excluding hormonal methods) from the first dose until 7 weeks after the last dose of the investigational product, to prevent pregnancy for themselves or their spouse/partner, and who agree not to donate sperm or ova
* Medically acceptable contraception: Use of intrauterine devices, vasectomy, tubal ligation, and/or barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or the use of spermicide in combination with at least two barrier methods
* Subjects who voluntarily sign the informed consent form after receiving and fully understanding sufficient explanation regarding the purpose, procedures, characteristics of the investigational product, and expected adverse events of the clinical…