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RCI001 Eye Drops 0.25% in Healthy Adult Male Participants

2026년 6월 5일 업데이트: 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.

연구 개요

연구 유형

중재적

등록 (실제)

40

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Seoul, 대한민국
        • Seoul national unversity hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른 이름들:
  • RCI001
위약 비교기: Placebo Eye Drops, Single-Day Administration, Once Daily
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
다른 이름들:
  • 일치하는 위약
실험적: 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.
다른 이름들:
  • RCI001
위약 비교기: Placebo Eye Drops, Single-Day Administration, Twice Daily
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
다른 이름들:
  • 일치하는 위약
실험적: 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.
다른 이름들:
  • RCI001
위약 비교기: Placebo Eye Drops, Single-Day Administration, Four Times Daily
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
다른 이름들:
  • 일치하는 위약
실험적: 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.
다른 이름들:
  • RCI001
위약 비교기: Placebo Eye Drops, Multiple-Day Administration, Twice Daily
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
다른 이름들:
  • 일치하는 위약
실험적: 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.
다른 이름들:
  • RCI001
위약 비교기: Placebo Eye Drops, Multiple-Day Administration, Four Times Daily
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
다른 이름들:
  • 일치하는 위약

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Adverse Events
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 10월 28일

기본 완료 (실제)

2025년 8월 29일

연구 완료 (실제)

2025년 9월 20일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 6월 5일

처음 게시됨 (실제)

2026년 6월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 5일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RDC001_101

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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