- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07640867
RCI001 Eye Drops 0.25% in Healthy Adult Male Participants
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
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Seoul, 대한민국
- Seoul national unversity hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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위약 비교기: 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.
다른 이름들:
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실험적: 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.
다른 이름들:
|
|
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:
|
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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:
|
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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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
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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
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
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: SeungHwan Lee, M.D., Ph.D., Seoul National University Hospital
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RDC001_101
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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