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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: 5% GLH8NDE; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

  1. A subject with suspected history or symptoms of visual organs, including keratitis, uveitis, retinitis, dry eye and strabismus
  2. A subject who has had eye surgery (including those who have received more than 6 months for eye laser surgery)
  3. A subject at least one eye with an intra-ocular pressure of 22 mmHg or more at the screening
  4. 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
  5. 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
  6. There are side effects to people who wear contact lenses after wearing them or within a month
• A subject with a history of drug abuse or a positive urine drug screening for drug abuse
• A subject who has participated in any other clinical trials and bioequivalence had medication within 6 months prior to the first administration of investigational product (The end date of another clinical trial is based on the last day of the administration)
• A subject who has taken any ethical-the-counter drug or herbal drug within 2 weeks has taken any over-the-counter drug or vitamin include artificial tears within 1 week before the investigational product
• A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration
• History of regular alcohol consumption exceeding 21 units/week (1 unit = 10 g of pure alcohol) within 60 days before the investigational product or non-stop the alcohol drinking
• The current smoker, but except the subject to quit the smoke over 90 days
• Recognized contraceptive methods (e.g. your and your partner's infertility surgery, your partner's intrauterine device (IUD), cervical caps or contraceptive diaphragms for use with spermicides) Single block), cervical cap or contraceptive diaphragm with male condom (double block)]
• A subject who have to work that cause excessive eye fatigue during this clinical trial
• A subject who is not eligible for the study due to reasons on the investigators' judgement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The A group in 5% GLH8NDE; Three times administration both eyes, each 1 drop in Korean	Drug: 5% GLH8NDE; 5% GLH8NDE as eye drops
Placebo Comparator: The A group in placebo; Three times administration both eyes, each 1 drop in Korean	Drug: Placebos; Placebo as eye drops
Experimental: The B group in 5% GLH8NDE; Six administration both eyes, each 1 drop in Korean	Drug: 5% GLH8NDE; 5% GLH8NDE as eye drops
Placebo Comparator: The B group in placebo; Six administration both eyes, each 1 drop in Korean	Drug: Placebos; Placebo as eye drops
Experimental: The C group in 5% GLH8NDE; Six administration both eyes, each 2 drop in Korean	Drug: 5% GLH8NDE; 5% GLH8NDE as eye drops
Placebo Comparator: The C group in placebo; Six administration both eyes, each 2 drop in Korean	Drug: Placebos; Placebo as eye drops
Experimental: The D group in 5% GLH8NDE; Six administration both eyes, each 2 drop in Caucasian	Drug: 5% GLH8NDE; 5% GLH8NDE as eye drops
Placebo Comparator: The D group in placebo; Six administration both eyes, each 2 drop in Caucasian	Drug: Placebos; Placebo as eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	To 18 days after first IP administration	Between 1 day before first IP administration and 18 days
Vital signs in blood pressure	Whether out of normal range at Blood pressure (SBP, DBP)	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)
Vital signs in pulse	Whether out of normal range at Pulse rate	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)
Vital signs in temperature	Whether out of normal range in temperature at eardrum	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)
Physical examinations in weight change	Weight change in kilograms	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)
Clinical laboratories in blood sample	Whether abnormal blood chemistry	Each point at day 1, 2, 4, 6, 8, 10, and 11
Clinical laboratories in blood sample	Whether positive at Type B hepatitis, Type C hepatitis, HIV, and Syphilis	Each point at day 1, 2, 4, 6, 8, 10, and 11
12-lead ECG in clinical significance	Whether out of normal range QRS complex	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)
Ophthalmic symptom	To 18 days after first IP administration	Each point at Day 1, 2, 4, 6, 8, 10, and 11
Ophthalmic examination	Tear break-up time examination	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)
AUClast in ng·h/mL	One day administration as GLH8NDE	Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
AUCinf in ng·h/mL	One day administration as GLH8NDE	Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
Cmax in ng/mL	One day administration as GLH8NDE	Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
Tmax in ng/mL	One day administration as GLH8NDE	Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
t1/2 in hour	One day administration as GLH8NDE	Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
AUCtau,ss in ng·h/mL	Mutiple dose administration as GLH8NDE	Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
Cmax in ng/mL	Mutiple dose administration as GLH8NDE	Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
Tmax in ng/mL	Mutiple dose administration as GLH8NDE	Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
t1/2 in hour	Mutiple dose administration as GLH8NDE	Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
R(Accumulation index)	Accumulation in dex at mutiple dose administration as GLH8NDE	Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

Collaborators and Investigators

• Sponsor: GL Pharm Tech Corporation
• Investigators: Study Director: MinChang Kwon, Ph. D, GL PharmTech Corp.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): February 18, 2020
• Study Completion (Actual): July 17, 2020

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: GLH8NDE-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No