drugset / Trial / NCT03648346

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

NCT03648346 ↗

Phase 1 Completed 16 enrolled Hanlim Pharm. Co., Ltd.
RandomizedSequentialTriple-blindBasic science

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).

Timeline

Start
2018-04-04
Primary completion
2018-07-25
Completion
2019-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject HL217 Unknown 3 mg/ml Other

Indications

No indication recorded.