NCT04104997

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

A Randomized, Double-blind, Placebo-controlled Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: GL Pharm Tech Corporation · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	5% GLH8NDE	5% GLH8NDE as eye drops
DRUG	Placebos	Placebo as eye drops

Timeline

• Start date: 2019-09-26
• Primary completion: 2020-02-18
• Completion: 2020-07-17
• First posted: 2019-09-26
• Last updated: 2020-12-19

Locations

1 site across 1 country: South Korea