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

Healthy Subjects Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03648346
Study type Interventional
Source Hanlim Pharm. Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date April 4, 2018
Completion date January 25, 2019
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