RCI001 Eye Drops 0.25% in Healthy Adult Male Participants

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.