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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: HL217 Ophathalmic Solution QD | Experimental | HL217 3mg/mL, Ophthalmic solution, two drop once a day |
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| Cohort 2: HL217 Ophathalmic Solution BID | Experimental | HL217 3mg/mL, Ophthalmic solution, two drop twice a day |
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| Cohort 3: HL217 Ophthalmic Solution QID | Experimental | HL217 3mg/mL, Ophthalmic solution, two drop four times a day |
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| Placebo Ophthalmic solution | Placebo Comparator | Placebo Ophthalmic solution, two drop once or twice or four times a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1: HL217 Ophathalmic Solution QD | Drug | Cohort 1 (Once a day) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | During 72hours |
| Local tolerance: Redness, Tingling and Other ophthalmic adverse events | Redness, tingling and others should be checked | During 72hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic assessment: Cmax | observed maximum plasma concentration of HL217 | 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour |
| Pharmacokinetic assessment: Tmax |
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Inclusion Criteria:
Healthy male subject, aged between 18 and 50 years inclusive
Non-smoker subject or smoker of not more than 10 cigarettes a day and able to stop smoking 24 hour prior to admission until discharge
Body weight ≥ 50 kg and BMI between 18 and 30 kg/m²
Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination) including complete ocular examination
Normal Blood Pressure (BP) and Heart Rate (HR) after 10 minutes in supine position:
Normal ECG recording on a 12-lead ECG:
Laboratory parameters within the normal range of the laboratory (haematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator
Normal dietary habits
Signing a written informed consent prior to selection
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Bell | BioKinetic Europe | Principal Investigator |
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| Cohort 2: HL217 Ophathalmic Solution BID | Drug | Cohort 2 (Twice a day) |
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| Cohort 3: HL217 Ophthalmic Solution QID | Drug | Cohort 3 (Four times a day) |
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| Placebo Ophthalmic solution | Drug | Placebo |
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first time to reach Cmax
| 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 | 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 | 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour |
| Pharmacokinetic assessment: Kel | elimination rate constant | 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 | 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 | 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour |
| Pharmacokinetic assessment: Cl/F | clearance | 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 | 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour |