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

NCT03648346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-03-29

No results posted yet for this study

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).

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • Hanlim Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yves Donazzolo, M.D · Eurofins Optimed

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03648346 on ClinicalTrials.gov