RCI001 Eye Drops 0.25% in Healthy Adult Male Participants

NCT07640867 | Completed Phase 1 DMC

• 1 other identifier: RDC001_101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

RCI001 Eye Drops; Dry Eye Diseases; Phase 1 Clinical Trial; Rudacure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration

  Predose on Day -1 through Day 11

• Maximum Observed Plasma Concentration (Cmax) of RCI001 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

  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

  Predose on Day -1 through Day 11.

• Terminal Elimination Half-Life (t1/2) of RCI001 After Single Administration

  Predose on Day -1 through Day 11.

Study Arms (10)

RCI001 Eye Drops 0.25%, Single-Day Administration, Once Daily

EXPERIMENTAL

Drug: RCI001 Eye Drops 0.25%

Placebo Eye Drops, Single-Day Administration, Once Daily

PLACEBO COMPARATOR

Drug: Placebo Eye Drops

RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Daily

EXPERIMENTAL

Drug: RCI001 Eye Drops 0.25%

Placebo Eye Drops, Single-Day Administration, Twice Daily

PLACEBO COMPARATOR

Drug: Placebo Eye Drops

RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Daily

EXPERIMENTAL

Drug: RCI001 Eye Drops 0.25%

Placebo Eye Drops, Single-Day Administration, Four Times Daily

PLACEBO COMPARATOR

Drug: Placebo Eye Drops

RCI001 Eye Drops 0.25%, Multiple-Day Administration, Twice Daily

EXPERIMENTAL

Drug: RCI001 Eye Drops 0.25%

Placebo Eye Drops, Multiple-Day Administration, Twice Daily

PLACEBO COMPARATOR

Drug: Placebo Eye Drops

RCI001 Eye Drops 0.25%, Multiple-Day Administration, Four Times Daily

EXPERIMENTAL

Drug: RCI001 Eye Drops 0.25%

Placebo Eye Drops, Multiple-Day Administration, Four Times Daily

PLACEBO COMPARATOR

Drug: Placebo Eye Drops

Interventions

RCI001 Eye Drops 0.25% DRUG

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

Also known as: RCI001

RCI001 Eye Drops 0.25%, Multiple-Day Administration, Four Times Daily; RCI001 Eye Drops 0.25%, Multiple-Day Administration, Twice Daily; RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Daily; RCI001 Eye Drops 0.25%, Single-Day Administration, Once Daily; RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Daily

Placebo Eye Drops DRUG

Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.

Also known as: Matching placebo

Placebo Eye Drops, Multiple-Day Administration, Four Times Daily; Placebo Eye Drops, Multiple-Day Administration, Twice Daily; Placebo Eye Drops, Single-Day Administration, Four Times Daily; Placebo Eye Drops, Single-Day Administration, Once Daily; Placebo Eye Drops, Single-Day Administration, Twice Daily

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male volunteers aged 19 to 50 years at screening.
• 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.
• 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.
• Participants who are considered eligible for this study by the investigator based on physical examination, clinical laboratory tests, medical interview, and other screening assessments.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• Participants who are considered unsuitable for participation in the study by the investigator for any other reason.

Sponsors & Collaborators

• Rudacure: lead

Study Sites (1)

Seoul national unversity hospital

Seoul, South Korea

Location

Related Publications (6)

• 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.

  PMID: 29923862 BACKGROUND

• 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.

  PMID: 33767351 BACKGROUND

• 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.

  PMID: 37877019 BACKGROUND

• 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.

  PMID: 38822444 BACKGROUND

• 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.

  PMID: 35401555 BACKGROUND

• 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.

  PMID: 36288559 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• SeungHwan Lee, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, care providers, and outcome assessors will remain masked to treatment assignment until the study is completed and the database is locked, except when unmasking is required for participant safety.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 11, 2026
• Study Start: October 28, 2024
• Primary Completion: August 29, 2025
• Study Completion: September 20, 2025
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)