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RCI001 Eye Drops 0.25% in Healthy Adult Male Participants

NCT07640867 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-11

No results posted yet for this study

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.

Conditions

  • Dry Eye

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.

Sponsors & Collaborators

  • Rudacure

    lead INDUSTRY

Principal Investigators

  • SeungHwan Lee, M.D., Ph.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2025-08-29
Completion
2025-09-20

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640867 on ClinicalTrials.gov