RCI001 Eye Drops 0.25% in Healthy Adult Male Participants
5 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
40
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Seoul, Coréia do Sul
- Seoul national unversity hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: RCI001 Eye Drops 0.25%, Single-Day Administration, Once Daily
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RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Outros nomes:
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Comparador de Placebo: Placebo Eye Drops, Single-Day Administration, Once Daily
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Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Outros nomes:
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Experimental: RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Daily
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RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Outros nomes:
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Comparador de Placebo: Placebo Eye Drops, Single-Day Administration, Twice Daily
|
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Outros nomes:
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Experimental: RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Daily
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RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Outros nomes:
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Comparador de Placebo: Placebo Eye Drops, Single-Day Administration, Four Times Daily
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Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Outros nomes:
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Experimental: 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.
Outros nomes:
|
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Comparador de Placebo: Placebo Eye Drops, Multiple-Day Administration, Twice Daily
|
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Outros nomes:
|
|
Experimental: 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.
Outros nomes:
|
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Comparador de 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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants With Adverse Events
Prazo: 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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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
Prazo: From baseline 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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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.
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From baseline through the post-study visit, up to Day 18 for single-administration cohorts and up to Day 32 for multiple-administration cohorts
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration
Prazo: Predose on Day -1 through Day 11
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Tmax will be calculated from plasma RCI001 concentration-time data after single administration.
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Predose on Day -1 through Day 11
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Maximum Observed Plasma Concentration (Cmax) of RCI001 After Single Administration
Prazo: Predose on Day -1 through Day 25
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Cmax will be calculated from plasma RCI001 concentration-time data after single administration.
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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
Prazo: Predose on Day -1 through Day 11.
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AUClast will be calculated from plasma RCI001 concentration-time data after single administration.
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Predose on Day -1 through Day 11.
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Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of RCI001 After Single Administration
Prazo: Predose on Day -1 through Day 11.
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AUCinf will be calculated from plasma RCI001 concentration-time data after single administration.
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Predose on Day -1 through Day 11.
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Terminal Elimination Half-Life (t1/2) of RCI001 After Single Administration
Prazo: Predose on Day -1 through Day 11.
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Terminal elimination half-life will be calculated from plasma RCI001 concentration-time data after single administration.
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Predose on Day -1 through Day 11.
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Apparent Clearance (CL/F) of RCI001 After Single Administration
Prazo: Predose on Day -1 through Day 11.
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CL/F will be calculated from plasma RCI001 concentration-time data after single administration.
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Predose on Day -1 through Day 11.
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Apparent Volume of Distribution (Vz/F) of RCI001 After Single Administration
Prazo: Predose on Day -1 through Day 11.
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Vz/F will be calculated from plasma RCI001 concentration-time data after single administration.
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Predose on Day -1 through Day 11.
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Time to Maximum Plasma Concentration at Steady State (Tmax,ss) of RCI001 After Multiple Administration
Prazo: Predose on Day -1 through Day 25.
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Tmax,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.
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Predose on Day -1 through Day 25.
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Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of RCI001 After Multiple Administration
Prazo: Predose on Day -1 through Day 25.
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Cmax,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.
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Predose on Day -1 through Day 25.
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Minimum Observed Plasma Concentration at Steady State (Cmin,ss) of RCI001 After Multiple Administration
Prazo: Predose on Day -1 through Day 25.
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Cmin,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.
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Predose on Day -1 through Day 25.
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Average Plasma Concentration at Steady State (Cavg,ss) of RCI001 After Multiple Administration
Prazo: Predose on Day -1 through Day 25.
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Cavg,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.
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Predose on Day -1 through Day 25.
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Trough Plasma Concentration (Ctrough) of RCI001 After Multiple Administration
Prazo: Predose on Day -1 through Day 25.
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Ctrough will be calculated from plasma RCI001 concentration-time data after multiple administration.
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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
Prazo: Predose on Day -1 through Day 25.
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AUCtau,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.
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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
Prazo: Predose on Day -1 through Day 25.
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Terminal elimination half-life at steady state will be calculated from plasma RCI001 concentration-time data after multiple administration.
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Predose on Day -1 through Day 25.
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Apparent Clearance at Steady State (CLss/F) of RCI001 After Multiple Administration
Prazo: Predose on Day -1 through Day 25.
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CLss/F will be calculated from plasma RCI001 concentration-time data after multiple administration.
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Predose on Day -1 through Day 25.
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Apparent Volume of Distribution at Steady State (Vz,ss/F) of RCI001 After Multiple Administration
Prazo: Predose on Day -1 through Day 25.
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Vz,ss/F will be calculated from plasma RCI001 concentration-time data after multiple administration.
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Predose on Day -1 through Day 25.
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Peak-to-Trough Fluctuation (PTF) of RCI001 After Multiple Administration
Prazo: Predose on Day -1 through Day 25.
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PTF will be calculated from plasma RCI001 concentration-time data after multiple administration.
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Predose on Day -1 through Day 25.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: SeungHwan Lee, M.D., Ph.D., Seoul National University Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
28 de outubro de 2024
Conclusão Primária (Real)
29 de agosto de 2025
Conclusão do estudo (Real)
20 de setembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
12 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de junho de 2026
Primeira postagem (Real)
11 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RDC001_101
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .