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RCI001 Eye Drops 0.25% in Healthy Adult Male Participants
Sponsor: Rudacure
Summary
This study is being conducted to evaluate the safety, tolerability, and pharmacokinetics of RCI001 eye drops 0.25% in healthy adult male participants. Pharmacokinetics means how the study drug is absorbed, distributed, and eliminated from the body over time. Participants who meet the study requirements will be randomly assigned to receive either RCI001 eye drops 0.25% or placebo eye drops. The study treatment will be administered to the left eye according to the assigned dosing schedule. The study includes single-dose administration schedules and multiple-dose administration schedules for up to 15 days. The study will monitor safety and tolerability through adverse event assessments, vital signs, physical examinations, electrocardiograms, laboratory tests, eye symptom assessments, and ophthalmic examinations. Blood samples will be collected at scheduled time points to measure the concentration of RCI001 in the blood. Approximately 40 healthy adult male participants are planned to take part in this study.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Administration Phase 1 Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of RCI001 Eye Drops 0.25% in Healthy Male Subjects
Key Details
Gender
MALE
Age Range
19 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-10-28
Completion Date
2025-09-20
Last Updated
2026-06-11
Healthy Volunteers
Yes
Conditions
Interventions
RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Locations (1)
Seoul national unversity hospital
Seoul, South Korea