RCI001 Eye Drops 0.25% in Healthy Adult Male Participants
5 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Seoul, Corée du Sud
- Seoul national unversity hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: RCI001 Eye Drops 0.25%, Single-Day Administration, Once Daily
|
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Autres noms:
|
|
Comparateur placebo: Placebo Eye Drops, Single-Day Administration, Once Daily
|
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Autres noms:
|
|
Expérimental: RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Daily
|
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Autres noms:
|
|
Comparateur placebo: Placebo Eye Drops, Single-Day Administration, Twice Daily
|
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Autres noms:
|
|
Expérimental: RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Daily
|
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Autres noms:
|
|
Comparateur placebo: Placebo Eye Drops, Single-Day Administration, Four Times Daily
|
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Autres noms:
|
|
Expérimental: RCI001 Eye Drops 0.25%, Multiple-Day Administration, Twice Daily
|
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Autres noms:
|
|
Comparateur placebo: Placebo Eye Drops, Multiple-Day Administration, Twice Daily
|
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Autres noms:
|
|
Expérimental: RCI001 Eye Drops 0.25%, Multiple-Day Administration, Four Times Daily
|
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Autres noms:
|
|
Comparateur placebo: Placebo Eye Drops, Multiple-Day Administration, Four Times Daily
|
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Adverse Events
Délai: 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.
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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
|
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Number of Participants With Clinically Significant Abnormalities in Safety Assessments
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration
Délai: 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
|
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Maximum Observed Plasma Concentration (Cmax) of RCI001 After Single Administration
Délai: 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
|
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Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of RCI001 After Single Administration
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
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Apparent Volume of Distribution (Vz/F) of RCI001 After Single Administration
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
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Average Plasma Concentration at Steady State (Cavg,ss) of RCI001 After Multiple Administration
Délai: 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
Délai: 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.
|
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Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of RCI001 After Multiple Administration
Délai: 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.
|
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Terminal Elimination Half-Life at Steady State (t1/2,ss) of RCI001 After Multiple Administration
Délai: 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.
|
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Apparent Clearance at Steady State (CLss/F) of RCI001 After Multiple Administration
Délai: 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
Délai: 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.
|
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Peak-to-Trough Fluctuation (PTF) of RCI001 After Multiple Administration
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: SeungHwan Lee, M.D., Ph.D., Seoul National University Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
28 octobre 2024
Achèvement primaire (Réel)
29 août 2025
Achèvement de l'étude (Réel)
20 septembre 2025
Dates d'inscription aux études
Première soumission
12 mai 2026
Première soumission répondant aux critères de contrôle qualité
5 juin 2026
Première publication (Réel)
11 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RDC001_101
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .