Clinical trial NCT04104997: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Syndromes
Lead sponsor: GL Pharm Tech Corporation
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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

  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

Primary outcomes:
measure: Adverse events
timeFrame: Between 1 day before first IP administration and 18 days
measure: Vital signs in blood pressure
timeFrame: 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)
measure: Vital signs in pulse
timeFrame: 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)
measure: Vital signs in temperature
timeFrame: 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)
measure: Physical examinations in weight change
timeFrame: 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)
measure: Clinical laboratories in blood sample
timeFrame: Each point at day 1, 2, 4, 6, 8, 10, and 11
measure: Clinical laboratories in blood sample
timeFrame: Each point at day 1, 2, 4, 6, 8, 10, and 11
measure: 12-lead ECG in clinical significance
timeFrame: 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)
measure: Ophthalmic symptom
timeFrame: Each point at Day 1, 2, 4, 6, 8, 10, and 11
measure: Ophthalmic examination
timeFrame: 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)
measure: AUClast in ng·h/mL
timeFrame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
measure: AUCinf in ng·h/mL
timeFrame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
measure: Cmax in ng/mL
timeFrame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
measure: Tmax in ng/mL
timeFrame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
measure: t1/2 in hour
timeFrame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
measure: AUCtau,ss in ng·h/mL
timeFrame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
measure: Cmax in ng/mL
timeFrame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
measure: Tmax in ng/mL
timeFrame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
measure: t1/2 in hour
timeFrame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
measure: R(Accumulation index)
timeFrame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: GL PharmTech Corp.
name: MinChang Kwon, Ph. D
role: STUDY_DIRECTOR
References: