RCI001 Eye Drops 0.25% in Healthy Adult Male Participants
2026年6月5日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
40
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Seoul、韓国
- Seoul national unversity hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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プラセボコンパレーター：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.
他の名前：
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実験的：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.
他の名前：
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プラセボコンパレーター：Placebo Eye Drops, Single-Day Administration, Twice Daily
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Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
他の名前：
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実験的：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.
他の名前：
|
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プラセボコンパレーター：Placebo Eye Drops, Single-Day Administration, Four Times Daily
|
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
他の名前：
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実験的：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.
他の名前：
|
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プラセボコンパレーター：Placebo Eye Drops, Multiple-Day Administration, Twice Daily
|
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
他の名前：
|
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実験的：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.
他の名前：
|
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プラセボコンパレーター：Placebo Eye Drops, Multiple-Day Administration, Four Times Daily
|
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Adverse Events
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：SeungHwan Lee, M.D., Ph.D.、Seoul National University Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年10月28日
一次修了 (実際)
2025年8月29日
研究の完了 (実際)
2025年9月20日
試験登録日
最初に提出
2026年5月12日
QC基準を満たした最初の提出物
2026年6月5日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月5日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- RDC001_101
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。