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RCI001 Eye Drops 0.25% in Healthy Adult Male Participants

5. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: RCI001 Eye Drops 0.25%, Single-Day Administration, Once Daily
Legemiddel: RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Andre navn:
  • RCI001
Placebo komparator: Placebo Eye Drops, Single-Day Administration, Once Daily
Legemiddel: Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Andre navn:
  • Matchende placebo
Eksperimentell: RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Daily
Legemiddel: RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Andre navn:
  • RCI001
Placebo komparator: Placebo Eye Drops, Single-Day Administration, Twice Daily
Legemiddel: Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Andre navn:
  • Matchende placebo
Eksperimentell: RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Daily
Legemiddel: RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Andre navn:
  • RCI001
Placebo komparator: Placebo Eye Drops, Single-Day Administration, Four Times Daily
Legemiddel: Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Andre navn:
  • Matchende placebo
Eksperimentell: RCI001 Eye Drops 0.25%, Multiple-Day Administration, Twice Daily
Legemiddel: RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Andre navn:
  • RCI001
Placebo komparator: Placebo Eye Drops, Multiple-Day Administration, Twice Daily
Legemiddel: Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Andre navn:
  • Matchende placebo
Eksperimentell: RCI001 Eye Drops 0.25%, Multiple-Day Administration, Four Times Daily
Legemiddel: RCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Andre navn:
  • RCI001
Placebo komparator: Placebo Eye Drops, Multiple-Day Administration, Four Times Daily
Legemiddel: Placebo Eye Drops
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Andre navn:
  • Matchende placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Adverse Events
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Rudacure

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. oktober 2024

Primær fullføring (Faktiske)

29. august 2025

Studiet fullført (Faktiske)

20. september 2025

Datoer for studieregistrering

Først innsendt

12. mai 2026

Først innsendt som oppfylte QC-kriteriene

5. juni 2026

Først lagt ut (Faktiske)

11. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RDC001_101

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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