Clinical Trials/NCT04104997

NCT04104997

Completed

Phase 1

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

GL Pharm Tech Corporation1 site in 1 country39 target enrollmentSeptember 26, 2019

ConditionsDry Eye Syndromes

Interventions5% GLH8NDE Placebos

Drugs5% GLH8NDE Placebos

Overview

Phase: Phase 1
Intervention: 5% GLH8NDE
Conditions: Dry Eye Syndromes
Sponsor: GL Pharm Tech Corporation
Enrollment: 39
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 26, 2019

End Date

July 17, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

GL Pharm Tech Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subject who, at the time of screening, are the age between 20 and 50 years
•Subject who has body weight between 55.0 and 90.0 kg, and BMI between 18.0 and 27.0
•Subject who signed and dated the informed consent form after understanding fully to hear a detailed explanation in the clinical trial

Exclusion Criteria

•A subject who has a evidence or history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, urological, psychiatric, cardiovascular, hematological, oncological, etc.
•A subject who has a history of disease with myocardial infarction, stroke, arrhythmia, hypotension (90 mmHg amine or diastolic blood pressure less than 50 mmHg at screening), uncontrolled hypertension (greater than 170 mmHg diastolic blood pressure or 100 mmHg diastolic blood pressure at screening), coronary artery, or who has a current abnormality
•A subject with a history of hypersensitivity to the drug (aspirin, antibiotics, etc.) or clinical significant hypersensitivity reactions
•A subject with the following findings in paperweight, visual acuity test, front eye photo, corneal refraction test, intraocular pressure test, slit lamp microscopy examination, fundus examination, tear break-up time examination, tear secretion test, OSDI (ocular surface disease index) are excluded
•A subject with suspected history or symptoms of visual organs, including keratitis, uveitis, retinitis, dry eye and strabismus
•A subject who has had eye surgery (including those who have received more than 6 months for eye laser surgery)
•A subject at least one eye with an intra-ocular pressure of 22 mmHg or more at the screening
•At the screening, tear break-up time of at least one eye in both eyes is less than 10 seconds and diagnosed as dry eye according to OSDI test
•A subject whose ratio for at least one eye in both eyes during screening is less than 10 mm as measured for 5 minutes in an Un-anesthetized Schirmer's test
•There are side effects to people who wear contact lenses after wearing them or within a month

Arms & Interventions

The A group in 5% GLH8NDE

Three times administration both eyes, each 1 drop in Korean

Intervention: 5% GLH8NDE

The A group in placebo

Three times administration both eyes, each 1 drop in Korean

Intervention: Placebos

The B group in 5% GLH8NDE

Six administration both eyes, each 1 drop in Korean

Intervention: 5% GLH8NDE

The B group in placebo

Six administration both eyes, each 1 drop in Korean

Intervention: Placebos

The C group in 5% GLH8NDE

Six administration both eyes, each 2 drop in Korean

Intervention: 5% GLH8NDE

The C group in placebo

Six administration both eyes, each 2 drop in Korean

Intervention: Placebos

The D group in 5% GLH8NDE

Six administration both eyes, each 2 drop in Caucasian

Intervention: 5% GLH8NDE

The D group in placebo

Six administration both eyes, each 2 drop in Caucasian

Intervention: Placebos

Outcomes

Primary Outcomes

Adverse events

Time Frame: Between 1 day before first IP administration and 18 days

To 18 days after first IP administration

Vital signs in blood pressure

Time Frame: Each point at Screening(between 2 day and 28 day before IP administration), 1, 2, 4, 6, 8, 10, 11 days, and post-study visit(between 16 and 18 days)

Whether out of normal range at Blood pressure (SBP, DBP)

Vital signs in pulse

Time Frame: Each point at Screening(between 2 day and 28 day before IP administration), 1, 2, 4, 6, 8, 10, 11 days, and post-study visit(between 16 and 18 days)

Whether out of normal range at Pulse rate

Vital signs in temperature

Time Frame: Each point at Screening(between 2 day and 28 day before IP administration), 1, 2, 4, 6, 8, 10, 11 days, and post-study visit(between 16 and 18 days)

Whether out of normal range in temperature at eardrum

Physical examinations in weight change

Time Frame: Change trend of the each point among screening(between 2 day and 28 day before IP administration), 1, 2, 4, 6, 8, 10, 11 days, and post-study visit(between 16 and 18 days)

Weight change in kilograms

Clinical laboratories in blood sample

Time Frame: Each point at day 1, 2, 4, 6, 8, 10, and 11

Whether positive at Type B hepatitis, Type C hepatitis, HIV, and Syphilis

12-lead ECG in clinical significance

Time Frame: Each point at Screening(between 2 day and 28 day before IP administration), 1, 4, 11 days, and post-study visit(between 16 and 18 days)

Whether out of normal range QRS complex

Ophthalmic symptom

Time Frame: Each point at Day 1, 2, 4, 6, 8, 10, and 11

To 18 days after first IP administration

Ophthalmic examination

Time Frame: Each point at Screening(between 2 day and 28 day before IP administration), 2, 11 days, and post-study visit(between 16 and 18 days)

Tear break-up time examination

AUClast in ng·h/mL