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RCI001 Eye Drops 0.25% in Healthy Adult Male Participants

5 juni 2026 bijgewerkt door: Rudacure

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

40

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Zuid -Korea
      • Seoul, Zuid -Korea
        • Seoul national unversity hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: RCI001 Eye Drops 0.25%, Single-Day Administration, Once Daily
Geneesmiddel: RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Andere namen:
  • RCI001
Placebo-vergelijker: Placebo Eye Drops, Single-Day Administration, Once Daily
Geneesmiddel: Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Andere namen:
  • Bijpassende placebo
Experimenteel: RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Daily
Geneesmiddel: RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Andere namen:
  • RCI001
Placebo-vergelijker: Placebo Eye Drops, Single-Day Administration, Twice Daily
Geneesmiddel: Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Andere namen:
  • Bijpassende placebo
Experimenteel: RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Daily
Geneesmiddel: RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Andere namen:
  • RCI001
Placebo-vergelijker: Placebo Eye Drops, Single-Day Administration, Four Times Daily
Geneesmiddel: Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Andere namen:
  • Bijpassende placebo
Experimenteel: RCI001 Eye Drops 0.25%, Multiple-Day Administration, Twice Daily
Geneesmiddel: RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Andere namen:
  • RCI001
Placebo-vergelijker: Placebo Eye Drops, Multiple-Day Administration, Twice Daily
Geneesmiddel: Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Andere namen:
  • Bijpassende placebo
Experimenteel: RCI001 Eye Drops 0.25%, Multiple-Day Administration, Four Times Daily
Geneesmiddel: RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Andere namen:
  • RCI001
Placebo-vergelijker: Placebo Eye Drops, Multiple-Day Administration, Four Times Daily
Geneesmiddel: Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Andere namen:
  • Bijpassende placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Adverse Events
Tijdsspanne: 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
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
Tijdsspanne: From baseline through the post-study visit, up to Day 18 for single-administration cohorts and up to Day 32 for multiple-administration cohorts
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration
Tijdsspanne: Predose on Day -1 through Day 11
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
Tijdsspanne: Predose on Day -1 through Day 25
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
Tijdsspanne: Predose on Day -1 through Day 11.
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
Tijdsspanne: Predose on Day -1 through Day 11.
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
Tijdsspanne: Predose on Day -1 through Day 11.
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
Tijdsspanne: Predose on Day -1 through Day 11.
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
Tijdsspanne: Predose on Day -1 through Day 11.
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
Tijdsspanne: Predose on Day -1 through Day 25.
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
Tijdsspanne: Predose on Day -1 through Day 25.
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
Tijdsspanne: Predose on Day -1 through Day 25.
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
Tijdsspanne: Predose on Day -1 through Day 25.
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
Tijdsspanne: Predose on Day -1 through Day 25.
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
Tijdsspanne: Predose on Day -1 through Day 25.
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
Tijdsspanne: Predose on Day -1 through Day 25.
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
Tijdsspanne: Predose on Day -1 through Day 25.
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
Tijdsspanne: Predose on Day -1 through Day 25.
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
Tijdsspanne: Predose on Day -1 through Day 25.
PTF will be calculated from plasma RCI001 concentration-time data after multiple administration.
Predose on Day -1 through Day 25.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Rudacure

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 oktober 2024

Primaire voltooiing (Werkelijk)

29 augustus 2025

Studie voltooiing (Werkelijk)

20 september 2025

Studieregistratiedata

Eerst ingediend

12 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 juni 2026

Eerst geplaatst (Werkelijk)

11 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

5 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RDC001_101

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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