NCT03648346

A Dose-escalation Clinical Trial After Multiple Dosing 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 Multiple Dosing of HL217 Eye Drop in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The study is a single center, double-blind, randomized, parallel group, multiple ascending dose study in 16 healthy male volunteers. Subjects will receive multiple eye drop doses during 14 days of the treatment (HL217 or placebo according to the randomization). There will be 2 cohorts of 8 subjects (6 HL217 vs 2 placebo) receiving the following doses: * Cohort 1 : two drops of 3 mg/mL of the treatment in one eye twice a day (low dose), * Cohort 2 : two drops of 3 mg/mL of the treatment in one eye 4 times a day (high dose).

Detailed description

The purpose of this study is to evaluate the safety and tolerability of HL217 after multiple eye drop administrations at different doses in healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Cohort 1: HL217 Ophathalmic Solution BID	Two drops of 3 mg/mL of the treatment in one eye twice a day
DRUG	Cohort 2: HL217 Ophathalmic Solution QID	Two drops of 3 mg/mL of the treatment in one eye 4 times a day
DRUG	Placebo	Placebo eye drops

Timeline

• Start date: 2018-04-04
• Primary completion: 2018-07-25
• Completion: 2019-01-25
• First posted: 2018-08-27
• Last updated: 2019-03-29

Locations

1 site across 1 country: France