NCT03650608

A Clinical Trial to Evaluate Tolerability and Pharmacokinetics of HL217 Eye Drop in Healthy Male Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and PK parameters in healthy subjects.

Detailed description

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.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
DRUG	Cohort 1: HL217 Ophathalmic Solution QD	Cohort 1 (Once a day)
DRUG	Cohort 2: HL217 Ophathalmic Solution BID	Cohort 2 (Twice a day)
DRUG	Cohort 3: HL217 Ophthalmic Solution QID	Cohort 3 (Four times a day)
DRUG	Placebo Ophthalmic solution	Placebo

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2018-08-29
• Last updated: 2019-04-01