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

GL Pharm Tech

Status and phase: Completed; Phase 1

Conditions: Dry Eye Syndromes

Treatments: Drug: 5% GLH8NDE; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT04104997

GLH8NDE-101

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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39 participants in 8 patient groups, including a placebo group

The A group in 5% GLH8NDE

Experimental group

Description:

Three times administration both eyes, each 1 drop in Korean

Treatment:

Drug: 5% GLH8NDE

The A group in placebo

Placebo Comparator group

Description:

Three times administration both eyes, each 1 drop in Korean

Treatment:

Drug: Placebos

The B group in 5% GLH8NDE

Experimental group

Description:

Six administration both eyes, each 1 drop in Korean

Treatment:

Drug: 5% GLH8NDE

The B group in placebo

Placebo Comparator group

Description:

Six administration both eyes, each 1 drop in Korean

Treatment:

Drug: Placebos

The C group in 5% GLH8NDE

Experimental group

Description:

Six administration both eyes, each 2 drop in Korean

Treatment:

Drug: 5% GLH8NDE

The C group in placebo

Placebo Comparator group

Description:

Six administration both eyes, each 2 drop in Korean

Treatment:

Drug: Placebos

The D group in 5% GLH8NDE

Experimental group

Description:

Six administration both eyes, each 2 drop in Caucasian

Treatment:

Drug: 5% GLH8NDE

The D group in placebo

Placebo Comparator group

Description:

Six administration both eyes, each 2 drop in Caucasian

Treatment:

Drug: Placebos