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COMPLETED
NCT07640867
PHASE1

RCI001 Eye Drops 0.25% in Healthy Adult Male Participants

Sponsor: Rudacure

View on ClinicalTrials.gov

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

DRUG

RCI001 Eye Drops 0.25%

RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.

DRUG

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