Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L… (NCT07533539) | Clinical Trial Compass
RecruitingPhase 1
Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of L03TD1 in Healthy Volunteers
South Korea48 participantsStarted 2026-05-09
Plain-language summary
This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the pharmacokinetics and safety after co-administration of L03RD1 and L03RD2 or administration of L03TD1 in healthy volunteers.
Who can participate
Age range19 Years – 55 Years
SexALL
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Inclusion Criteria:
* 1\) Subject is between 19 and 55 years of age, inclusive, at the time of screening.
* 2\) Subjects who have a BMI between 18.0 and 29.9 kg/m², inclusive, at the time of screening (Body weight ≥50 kg for males, ≥45 kg for females).
* 3\) Subjects who have a seated blood pressure at the time of screening between 90 and 139 mmHg systolic and between 60 and 89 mmHg diastolic, inclusive.
* 4\) Subjects who do not have clinically significant congenital or chronic diseases and do not have pathological symptoms or findings as a result of internal medical examination. (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography, etc.)
* 5\) Subjects who are determined by the principal investigator(or the delegated investigator) to be suitable as a study subject based on the results of assessments performed during screening, such as diagnostic tests(e.g., hematology test, blood chemistry test, serology test, urinalysis) and electrocardiogram(ECG) conducted in accordance with the characteristics of the investigational product.
* 6\) Subjects or their spouse or partner agree to use a highly effective contraceptive methods\* (excluding hormonal agents) to rule out the possibility of pregnancy from the date of first administration of the investigational product until 14 days after the last administration of the investigational product. They also agree not to donate sperm or eggs.
\* Highly effective contrac…