To evaluate the safety, local tolerability and pharmacokinetic characteristics after administration of eye-drop HL036 in healthy Korean male volunteers
A total of 10 subjects will be dosed in each group with subjects randomized 8:2 to HL036 or placebo. Three of 10 subjects will be randomized to the sentinel dosing in each group. A safety data review as masking will be performed for 3days prior to the other subjects treatment. Treatment of high dose will proceed following a review of safety data from low dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
Seoul, South Korea
Adverse Events
Time frame: 1 week
Peak Plasma Concentration (Cmax)
Time frame: 24 hours
Area under the plasma concentration versus time curve (AUC)
Time frame: 24 hours
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