RCI001 Eye Drops 0.25% in Healthy Adult Male Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: RCI001 Eye Drops 0.25%; Drug: Placebo Eye Drops

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Seoul national unversity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult male volunteers aged 19 to 50 years at screening.
2. Body weight of 50.0 kg to 90.0 kg and body mass index (BMI) of 18.5 kg/m2 to 29.9 kg/m2 at screening.
3. Participants who have received sufficient explanation about the study, fully understand the study, voluntarily decide to participate, and provide written informed consent to comply with study requirements.
4. Participants who are considered eligible for this study by the investigator based on physical examination, clinical laboratory tests, medical interview, and other screening assessments.

Exclusion Criteria:

1. Participants with a current or past history of clinically significant disease in the hepatobiliary system, kidney, nervous system, immune system, respiratory system, gastrointestinal system, endocrine system, hematologic or oncologic system, cardiovascular system, urinary system, or psychiatric system, including but not limited to severe hepatic impairment, viral hepatitis, severe renal impairment, heart failure, Torsade de pointes, mood disorder, or obsessive-compulsive disorder.
2. Participation in another clinical trial, including a bioequivalence study, and administration of an investigational product within 6 months before the first planned administration of the investigational product.
3. Current smoker who cannot stop smoking during the study period. Participants who stopped smoking at least 3 months before the first planned administration of the investigational product may be eligible.
4. Consumption of grapefruit, grapefruit juice, or grapefruit-containing foods from 3 days before the first planned administration of the investigational product until the end of the study, or inability to abstain from grapefruit-containing foods and beverages during this period.
5. Participants who are considered unsuitable for participation in the study by the investigator for any other reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RCI001 Eye Drops 0.25%, Single-Day Administration, Once Daily	Drug: RCI001 Eye Drops 0.25%; RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.; Other Names: RCI001
Placebo Comparator: Placebo Eye Drops, Single-Day Administration, Once Daily	Drug: Placebo Eye Drops; Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.; Other Names: Matching placebo
Experimental: RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Daily	Drug: RCI001 Eye Drops 0.25%; RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.; Other Names: RCI001
Placebo Comparator: Placebo Eye Drops, Single-Day Administration, Twice Daily	Drug: Placebo Eye Drops; Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.; Other Names: Matching placebo
Experimental: RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Daily	Drug: RCI001 Eye Drops 0.25%; RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.; Other Names: RCI001
Placebo Comparator: Placebo Eye Drops, Single-Day Administration, Four Times Daily	Drug: Placebo Eye Drops; Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.; Other Names: Matching placebo
Experimental: RCI001 Eye Drops 0.25%, Multiple-Day Administration, Twice Daily	Drug: RCI001 Eye Drops 0.25%; RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.; Other Names: RCI001
Placebo Comparator: Placebo Eye Drops, Multiple-Day Administration, Twice Daily	Drug: Placebo Eye Drops; Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.; Other Names: Matching placebo
Experimental: RCI001 Eye Drops 0.25%, Multiple-Day Administration, Four Times Daily	Drug: RCI001 Eye Drops 0.25%; RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.; Other Names: RCI001
Placebo Comparator: Placebo Eye Drops, Multiple-Day Administration, Four Times Daily	Drug: Placebo Eye Drops; Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.; Other Names: Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	The number and percentage of participants with adverse events will be summarized by treatment group. Adverse events will be assessed for seriousness, severity, relationship to the study drug, action taken, outcome, and whether they are treatment-emergent adverse events.	From informed consent through the post-study visit, up to Day 18 for single-administration cohorts and up to Day 32 for multiple-administration cohorts
Number of Participants With Clinically Significant Abnormalities in Safety Assessments	Safety assessments will include vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, ocular symptom assessments, and ophthalmic examinations. Clinically significant abnormalities will be summarized by treatment group.	From baseline through the post-study visit, up to Day 18 for single-administration cohorts and up to Day 32 for multiple-administration cohorts

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration	Tmax will be calculated from plasma RCI001 concentration-time data after single administration.	Predose on Day -1 through Day 11
Maximum Observed Plasma Concentration (Cmax) of RCI001 After Single Administration	Cmax will be calculated from plasma RCI001 concentration-time data after single administration.	Predose on Day -1 through Day 25
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of RCI001 After Single Administration	AUClast will be calculated from plasma RCI001 concentration-time data after single administration.	Predose on Day -1 through Day 11.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of RCI001 After Single Administration	AUCinf will be calculated from plasma RCI001 concentration-time data after single administration.	Predose on Day -1 through Day 11.
Terminal Elimination Half-Life (t1/2) of RCI001 After Single Administration	Terminal elimination half-life will be calculated from plasma RCI001 concentration-time data after single administration.	Predose on Day -1 through Day 11.
Apparent Clearance (CL/F) of RCI001 After Single Administration	CL/F will be calculated from plasma RCI001 concentration-time data after single administration.	Predose on Day -1 through Day 11.
Apparent Volume of Distribution (Vz/F) of RCI001 After Single Administration	Vz/F will be calculated from plasma RCI001 concentration-time data after single administration.	Predose on Day -1 through Day 11.
Time to Maximum Plasma Concentration at Steady State (Tmax,ss) of RCI001 After Multiple Administration	Tmax,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.	Predose on Day -1 through Day 25.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of RCI001 After Multiple Administration	Cmax,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.	Predose on Day -1 through Day 25.
Minimum Observed Plasma Concentration at Steady State (Cmin,ss) of RCI001 After Multiple Administration	Cmin,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.	Predose on Day -1 through Day 25.
Average Plasma Concentration at Steady State (Cavg,ss) of RCI001 After Multiple Administration	Cavg,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.	Predose on Day -1 through Day 25.
Trough Plasma Concentration (Ctrough) of RCI001 After Multiple Administration	Ctrough will be calculated from plasma RCI001 concentration-time data after multiple administration.	Predose on Day -1 through Day 25.
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of RCI001 After Multiple Administration	AUCtau,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.	Predose on Day -1 through Day 25.
Terminal Elimination Half-Life at Steady State (t1/2,ss) of RCI001 After Multiple Administration	Terminal elimination half-life at steady state will be calculated from plasma RCI001 concentration-time data after multiple administration.	Predose on Day -1 through Day 25.
Apparent Clearance at Steady State (CLss/F) of RCI001 After Multiple Administration	CLss/F will be calculated from plasma RCI001 concentration-time data after multiple administration.	Predose on Day -1 through Day 25.
Apparent Volume of Distribution at Steady State (Vz,ss/F) of RCI001 After Multiple Administration	Vz,ss/F will be calculated from plasma RCI001 concentration-time data after multiple administration.	Predose on Day -1 through Day 25.
Peak-to-Trough Fluctuation (PTF) of RCI001 After Multiple Administration	PTF will be calculated from plasma RCI001 concentration-time data after multiple administration.	Predose on Day -1 through Day 25.

Collaborators and Investigators

• Sponsor: Rudacure
• Investigators: Principal Investigator: SeungHwan Lee, M.D., Ph.D., Seoul National University Hospital

Publications and helpful links

General Publications

• Im ST, Kim HY, Yoon JY, Oh JY, Kim MK, Chung MH, Paik HJ, Kim DH. Therapeutic Effects of Topical 8-Oxo-2'-deoxyguanosine on Ethanol-Induced Ocular Chemical Injury Models. Cornea. 2018 Oct;37(10):1311-1317. doi: 10.1097/ICO.0000000000001671.
• Kim DH, Im ST, Yoon JY, Kim S, Kim MK, Chung MH, Park CK. Comparison of therapeutic effects between topical 8-oxo-2'-deoxyguanosine and corticosteroid in ocular alkali burn model. Sci Rep. 2021 Mar 25;11(1):6909. doi: 10.1038/s41598-021-86440-7.
• Kim SH, Ku YA, Yoo C, Kim YH, Kim DH. Comparison of RCI001 and corticosteroid on the effects on intraocular pressure in mice. Front Med (Lausanne). 2023 Oct 9;10:1256569. doi: 10.3389/fmed.2023.1256569. eCollection 2023.
• Jung YH, Ku YA, Moon J, Kim S, Ryu JS, Yoon CH, Chung MH, Kim YH, Kim MK, Kim DH. Efficacy of RCI001 as a therapeutic candidate of dry eye disease in a modified mixed dry eye model. Eye Vis (Lond). 2024 Jun 1;11(1):19. doi: 10.1186/s40662-024-00388-z.
• Kim S, Jang YW, Ku YA, Shin Y, Rahman MM, Chung MH, Kim YH, Kim DH. Investigating the Anti-Inflammatory Effects of RCI001 for Treating Ocular Surface Diseases: Insight Into the Mechanism of Action. Front Immunol. 2022 Mar 24;13:850287. doi: 10.3389/fimmu.2022.850287. eCollection 2022.
• Chung H, Ha Y, Kim YH, Kim DH, Shin D. Ocular Distribution and Pharmacokinetics of 8-Oxo-2'-Deoxyguanosine: A Novel Therapeutic Candidate of Ocular Surface Diseases. J Ocul Pharmacol Ther. 2022 Oct;38(8):561-566. doi: 10.1089/jop.2022.0054.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Actual): August 29, 2025
• Study Completion (Actual): September 20, 2025

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Phase 1 Clinical Trial; Rudacure; RCI001 Eye Drops; Dry Eye Diseases
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: RDC001_101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available to other researchers. The study has been completed and the results are planned to be submitted for publication. De-identified individual participant-level data are not planned for external sharing due to participant confidentiality, informed consent, regulatory, legal, and proprietary considerations related to the investigational drug product. Aggregate results may be disclosed through ClinicalTrials.gov, scientific publication, and/or regulatory submissions, as applicable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No