The purpose of this study is to evaluate the safety, tolerability and PK parameters in healthy subjects.
The purpose of this study is to evaluate the safety, tolerability and PK parameters of HL217 after single eye drop administration at different doses in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
24
Cohort 1 (Once a day)
Cohort 2 (Twice a day)
Cohort 3 (Four times a day)
Clinical parameter: Adverse Events (AE)
AEs will be coded according to the MedDRA. They will be classified into pre-defined standard categories according to chronological criteria
Time frame: During 72hours
Local tolerance: Redness, Tingling and Other ophthalmic adverse events
Redness, tingling and others should be checked
Time frame: During 72hours
Pharmacokinetic assessment: Cmax
observed maximum plasma concentration of HL217
Time frame: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour
Pharmacokinetic assessment: Tmax
first time to reach Cmax
Time frame: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour
Pharmacokinetic assessment: AUClast
area under the plasma concentration curve from administration up to the last quantifiable concentration at time 72h
Time frame: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour
Pharmacokinetic assessment: AUCinf
area under the plasma concentration-time curve from administration up to infinity with extrapolation of the terminal phase
Time frame: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour
Pharmacokinetic assessment: Kel
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Placebo
elimination rate constant
Time frame: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour
Pharmacokinetic assessment: T1/2
plasma elimination half-life
Time frame: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour
Pharmacokinetic assessment: %AUCextra
percentage of extrapolated AUCinf
Time frame: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour
Pharmacokinetic assessment: Cl/F
clearance
Time frame: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour
Pharmacokinetic assessment: Vd/F
volume of distribution
Time frame: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour