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A Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Single Dosing of HL217 Eye Drop in Healthy Male Subjects
The purpose of this study is to evaluate the safety, tolerability and PK parameters in healthy subjects.
Details
| Lead sponsor | Hanlim Pharm. Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2016-08 |
| Completion | 2017-08 |
Conditions
- Healthy Subject
Interventions
- Cohort 1: HL217 Ophathalmic Solution QD
- Cohort 2: HL217 Ophathalmic Solution BID
- Cohort 3: HL217 Ophthalmic Solution QID
- Placebo Ophthalmic solution
Primary outcomes
- Clinical parameter: Adverse Events (AE) — During 72hours
AEs will be coded according to the MedDRA. They will be classified into pre-defined standard categories according to chronological criteria - Local tolerance: Redness, Tingling and Other ophthalmic adverse events — During 72hours
Redness, tingling and others should be checked