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 | Completed Phase 1

• 1 other identifier: GLH8NDE-101
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (20)

• 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

Study Arms (8)

The A group in 5% GLH8NDE

EXPERIMENTAL

Three times administration both eyes, each 1 drop in Korean

Drug: 5% GLH8NDE

The A group in placebo

PLACEBO COMPARATOR

Three times administration both eyes, each 1 drop in Korean

Drug: Placebos

The B group in 5% GLH8NDE

EXPERIMENTAL

Six administration both eyes, each 1 drop in Korean

Drug: 5% GLH8NDE

The B group in placebo

PLACEBO COMPARATOR

Six administration both eyes, each 1 drop in Korean

Drug: Placebos

The C group in 5% GLH8NDE

EXPERIMENTAL

Six administration both eyes, each 2 drop in Korean

Drug: 5% GLH8NDE

The C group in placebo

PLACEBO COMPARATOR

Six administration both eyes, each 2 drop in Korean

Drug: Placebos

The D group in 5% GLH8NDE

EXPERIMENTAL

Six administration both eyes, each 2 drop in Caucasian

Drug: 5% GLH8NDE

The D group in placebo

PLACEBO COMPARATOR

Six administration both eyes, each 2 drop in Caucasian

Drug: Placebos

Interventions

5% GLH8NDE DRUG

5% GLH8NDE as eye drops

The A group in 5% GLH8NDE; The B group in 5% GLH8NDE; The C group in 5% GLH8NDE; The D group in 5% GLH8NDE

Placebos DRUG

Placebo as eye drops

The A group in placebo; The B group in placebo; The C group in placebo; The D group in placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• GL Pharm Tech Corporation: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• MinChang Kwon, Ph. D

  GL PharmTech Corp.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 26, 2019
• Study Start: September 26, 2019
• Primary Completion: February 18, 2020
• Study Completion: July 17, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

KR (1)