[KSR-001-P01]Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001

After single dose, safety and local tolerability were confirmed and repeated test was conducted according to the investigator's judgment.

Inclusion criteria

• Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.
• Body weight >= 50 kilogram and ideal body weight within the range ±20%.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion criteria

• A subject who has symptoms of suspected acute disease at the time of screening.
• Subjects with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, musculoskeletal, immune, the nose and ears, psychiatry, stomach system.
• A subject determined to be unsuitable as a subject through a physical examined during screening.
• A subject who is determined to be unsuitable as a subject through an ophthalmologic examination performed during screening.
• A subject with a history of ophthalmic surgery, trauma and chronic diseases.
• A subject who has acute or chronic eye disease requiring the use of local eye drops at the time of screening.
• Subjects who need to wear contact lenses during clinical trial period.
• A subject with clinically significant allergic disease.
• A subject with a history of drug abuse.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).
• A subject who takes drugs that induce and inhibit drug metabolises such as barbital medicines within one month before the administration of clinical trial drugs.
• A subject who donates blood to the whole blood within 60 days before the administration of a clinical trial drug or a person who donates blood to the component within 20 days before the administration of a clinical trial drug.
• A subject who has taken a specialty drug or herbal medicine within 14 days of administration of a clinical trial drug or a general medicine or vitamin formulation within 7 days.
• A subject who can not continually ingest caffeine or ingest caffeine-containing foods during the period from 24 hours to discharge from hospital.
• A subject who can not drink alcohol continuously or during the period from 24 hours to discharge from hospital.
• A subject who can not smoke excessively or quit smoking during the period from 24 hours to discharge from hospital.
• A subject who investigator that a tester is unsuitable for participating in clinical trials due to other reasons.