RCI001 Eye Drops 0.25% in Healthy Adult Male Participants

Rudacure40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dry Eye

Interventions

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

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.

Time frame: 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

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.

Time frame: From baseline through the post-study visit, up to Day 18 for single-administration cohorts and up to Day 32 for multiple-administration cohorts

Secondary Outcomes

Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration

Tmax will be calculated from plasma RCI001 concentration-time data after single administration.

Time frame: Predose on Day -1 through Day 11

Maximum Observed Plasma Concentration (Cmax) of RCI001 After Single Administration

Cmax will be calculated from plasma RCI001 concentration-time data after single administration.

Time frame: 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

AUClast will be calculated from plasma RCI001 concentration-time data after single administration.

Time frame: 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

AUCinf will be calculated from plasma RCI001 concentration-time data after single administration.

Time frame: Predose on Day -1 through Day 11.

Terminal Elimination Half-Life (t1/2) of RCI001 After Single Administration

Terminal elimination half-life will be calculated from plasma RCI001 concentration-time data after single administration.

Time frame: Predose on Day -1 through Day 11.

Apparent Clearance (CL/F) of RCI001 After Single Administration

CL/F will be calculated from plasma RCI001 concentration-time data after single administration.

Time frame: Predose on Day -1 through Day 11.

Apparent Volume of Distribution (Vz/F) of RCI001 After Single Administration

Vz/F will be calculated from plasma RCI001 concentration-time data after single administration.

Time frame: Predose on Day -1 through Day 11.

Time to Maximum Plasma Concentration at Steady State (Tmax,ss) of RCI001 After Multiple Administration

Tmax,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.