Dry Eye
Conditions
Keywords
RCI001 Eye Drops, Dry Eye Diseases, Phase 1 Clinical Trial, Rudacure
Brief summary
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.
Interventions
DRUGRCI001 Eye Drops 0.25%
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.
Sponsors
Rudacure
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, investigators, care providers, and outcome assessors will remain masked to treatment assignment until the study is completed and the database is locked, except when unmasking is required for participant safety.
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 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 | 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. |
| Number of Participants With Clinically Significant Abnormalities in Safety Assessments | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration | Predose on Day -1 through Day 11 | Tmax will be calculated from plasma RCI001 concentration-time data after single administration. |
| Maximum Observed Plasma Concentration (Cmax) of RCI001 After Single Administration | Predose on Day -1 through Day 25 | Cmax will be calculated from plasma RCI001 concentration-time data after single administration. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of RCI001 After Single Administration | Predose on Day -1 through Day 11. | AUClast will be calculated from plasma RCI001 concentration-time data after single administration. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of RCI001 After Single Administration | Predose on Day -1 through Day 11. | AUCinf will be calculated from plasma RCI001 concentration-time data after single administration. |
| Terminal Elimination Half-Life (t1/2) of RCI001 After Single Administration | Predose on Day -1 through Day 11. | Terminal elimination half-life will be calculated from plasma RCI001 concentration-time data after single administration. |
| Apparent Clearance (CL/F) of RCI001 After Single Administration | Predose on Day -1 through Day 11. | CL/F will be calculated from plasma RCI001 concentration-time data after single administration. |
| Apparent Volume of Distribution (Vz/F) of RCI001 After Single Administration | Predose on Day -1 through Day 11. | Vz/F will be calculated from plasma RCI001 concentration-time data after single administration. |
| Time to Maximum Plasma Concentration at Steady State (Tmax,ss) of RCI001 After Multiple Administration | Predose on Day -1 through Day 25. | Tmax,ss will be calculated from plasma RCI001 concentration-time data after multiple administration. |
| Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of RCI001 After Multiple Administration | Predose on Day -1 through Day 25. | Cmax,ss will be calculated from plasma RCI001 concentration-time data after multiple administration. |
| Minimum Observed Plasma Concentration at Steady State (Cmin,ss) of RCI001 After Multiple Administration | Predose on Day -1 through Day 25. | Cmin,ss will be calculated from plasma RCI001 concentration-time data after multiple administration. |
| Average Plasma Concentration at Steady State (Cavg,ss) of RCI001 After Multiple Administration | Predose on Day -1 through Day 25. | Cavg,ss will be calculated from plasma RCI001 concentration-time data after multiple administration. |
| Trough Plasma Concentration (Ctrough) of RCI001 After Multiple Administration | Predose on Day -1 through Day 25. | Ctrough will be calculated from plasma RCI001 concentration-time data after multiple administration. |
| Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of RCI001 After Multiple Administration | Predose on Day -1 through Day 25. | AUCtau,ss will be calculated from plasma RCI001 concentration-time data after multiple administration. |
| Terminal Elimination Half-Life at Steady State (t1/2,ss) of RCI001 After Multiple Administration | 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. |
| Apparent Clearance at Steady State (CLss/F) of RCI001 After Multiple Administration | Predose on Day -1 through Day 25. | CLss/F will be calculated from plasma RCI001 concentration-time data after multiple administration. |
| Apparent Volume of Distribution at Steady State (Vz,ss/F) of RCI001 After Multiple Administration | Predose on Day -1 through Day 25. | Vz,ss/F will be calculated from plasma RCI001 concentration-time data after multiple administration. |
| Peak-to-Trough Fluctuation (PTF) of RCI001 After Multiple Administration | Predose on Day -1 through Day 25. | PTF will be calculated from plasma RCI001 concentration-time data after multiple administration. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSeungHwan Lee, M.D., Ph.D.
Seoul National University Hospital
Outcome results
None listed