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A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers

NCT04104997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-12-19

No results posted yet for this study

Summary

This study is a randomized, double-blind, placebo-controlled phase 1 clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of GLH8NDE after single and multiple ocular administrations in healthy Korean and Caucasian volunteers

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

5% GLH8NDE

5% GLH8NDE as eye drops

DRUG

Placebos

Placebo as eye drops

Sponsors & Collaborators

  • GL Pharm Tech Corporation

    lead INDUSTRY

Principal Investigators

  • MinChang Kwon, Ph. D · GL PharmTech Corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2020-02-18
Completion
2020-07-17

Countries

  • South Korea

Study Locations

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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 NCT04104997 on ClinicalTrials.gov