临床试验/NCT04104997

NCT04104997已完成1 期

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 个研究点分布在 1 个国家目标入组 39 人开始时间: 2019年9月26日最近更新: 2020年12月19日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 39
试验地点: 1
主要终点: Adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 20 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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
•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

研究组 & 干预措施

The A group in 5% GLH8NDE

Experimental

Three times administration both eyes, each 1 drop in Korean

干预措施: 5% GLH8NDE (Drug)

The A group in placebo

Placebo Comparator

Three times administration both eyes, each 1 drop in Korean

干预措施: Placebos (Drug)

The B group in 5% GLH8NDE

Experimental

Six administration both eyes, each 1 drop in Korean

干预措施: 5% GLH8NDE (Drug)

The B group in placebo

Placebo Comparator

Six administration both eyes, each 1 drop in Korean

干预措施: Placebos (Drug)

The C group in 5% GLH8NDE

Experimental

Six administration both eyes, each 2 drop in Korean

干预措施: 5% GLH8NDE (Drug)

The C group in placebo

Placebo Comparator

Six administration both eyes, each 2 drop in Korean

干预措施: Placebos (Drug)

The D group in 5% GLH8NDE

Experimental

Six administration both eyes, each 2 drop in Caucasian

干预措施: 5% GLH8NDE (Drug)

The D group in placebo

Placebo Comparator

Six administration both eyes, each 2 drop in Caucasian

干预措施: Placebos (Drug)

结局指标

主要结局

Adverse events

时间窗: Between 1 day before first IP administration and 18 days

To 18 days after first IP administration

Vital signs in blood pressure

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Each point at Day 1, 2, 4, 6, 8, 10, and 11

To 18 days after first IP administration

Ophthalmic examination

时间窗: 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