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Completed

NCT Number: 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

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

5% GLH8NDE

Drug

5% GLH8NDE as eye drops

Placebos

Drug

Placebo as eye drops

Primary outcomes

  1. Adverse events

    Time frame: Between 1 day before first IP administration and 18 days

    To 18 days after first IP administration

  2. Vital signs in blood pressure

    Time frame: 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)

  3. Vital signs in pulse

    Time frame: 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

  4. Vital signs in temperature

    Time frame: 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

  5. Physical examinations in weight change

    Time frame: 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

  6. Clinical laboratories in blood sample

    Time frame: Each point at day 1, 2, 4, 6, 8, 10, and 11

    Whether abnormal blood chemistry

  7. Clinical laboratories in blood sample

    Time frame: Each point at day 1, 2, 4, 6, 8, 10, and 11

    Whether positive at Type B hepatitis, Type C hepatitis, HIV, and Syphilis

  8. 12-lead ECG in clinical significance

    Time frame: 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

  9. Ophthalmic symptom

    Time frame: Each point at Day 1, 2, 4, 6, 8, 10, and 11

    To 18 days after first IP administration

  10. Ophthalmic examination

    Time frame: 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

  11. AUClast in ng·h/mL

    Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

    One day administration as GLH8NDE

  12. AUCinf in ng·h/mL

    Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

    One day administration as GLH8NDE

  13. Cmax in ng/mL

    Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

    One day administration as GLH8NDE

  14. Tmax in ng/mL

    Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

    One day administration as GLH8NDE

  15. t1/2 in hour

    Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

    One day administration as GLH8NDE

  16. AUCtau,ss in ng·h/mL

    Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

    Mutiple dose administration as GLH8NDE

  17. Cmax in ng/mL

    Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

    Mutiple dose administration as GLH8NDE

  18. Tmax in ng/mL

    Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

    Mutiple dose administration as GLH8NDE

  19. t1/2 in hour

    Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

    Mutiple dose administration as GLH8NDE

  20. R(Accumulation index)

    Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration

    Accumulation in dex at mutiple dose administration as GLH8NDE

Sponsors and collaborators

Lead sponsor

GL Pharm Tech Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2019
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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