Dry Eye SyndromesPhase 1NCT04104997
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
A Phase 1 study testing 5% GLH8NDE in people with Dry Eye Syndromes, run by GL Pharm Tech Corporation at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- 5% GLH8NDE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Sep 2019to 17 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
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
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
- Being tested
- 5% GLH8NDE, Placebos
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% GLH8NDEDrug
5% GLH8NDE as eye drops
PlacebosDrug
Placebo as eye drops
| Study group | Role | What they receive |
|---|---|---|
| The A group in 5% GLH8NDE | Experimental | Three times administration both eyes, each 1 drop in Korean Receives: Drug: 5% GLH8NDE |
| The A group in placebo | Placebo comparator | Three times administration both eyes, each 1 drop in Korean Receives: Drug: Placebos |
| The B group in 5% GLH8NDE | Experimental | Six administration both eyes, each 1 drop in Korean Receives: Drug: 5% GLH8NDE |
| The B group in placebo | Placebo comparator | Six administration both eyes, each 1 drop in Korean Receives: Drug: Placebos |
| The C group in 5% GLH8NDE | Experimental | Six administration both eyes, each 2 drop in Korean Receives: Drug: 5% GLH8NDE |
| The C group in placebo | Placebo comparator | Six administration both eyes, each 2 drop in Korean Receives: Drug: Placebos |
| The D group in 5% GLH8NDE | Experimental | Six administration both eyes, each 2 drop in Caucasian Receives: Drug: 5% GLH8NDE |
| The D group in placebo | Placebo comparator | Six administration both eyes, each 2 drop in Caucasian Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
To 18 days after first IP administration
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Each point at Day 1, 2, 4, 6, 8, 10, and 11
Ophthalmic examination
Tear break-up time examination
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start26 Sep 2019
- Primary completion18 Feb 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- GL Pharm Tech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MinChang Kwon, Ph. D, Study director, GL PharmTech Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104997
- Sponsor's protocol ID
- GLH8NDE-101
- Status last verified
- Dec 2020
- First submitted
- 20 Sep 2019
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04104997
- Acronym / sponsor ID
- GLH8NDE-101
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- GL Pharm Tech CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| The A group in 5% GLH8NDE | Experimental | Drug: 5% GLH8NDEThree times administration both eyes, each 1 drop in Korean |
| The A group in placebo | Placebo comparator | Drug: PlacebosThree times administration both eyes, each 1 drop in Korean |
| The B group in 5% GLH8NDE | Experimental | Drug: 5% GLH8NDESix administration both eyes, each 1 drop in Korean |
| The B group in placebo | Placebo comparator | Drug: PlacebosSix administration both eyes, each 1 drop in Korean |
| The C group in 5% GLH8NDE | Experimental | Drug: 5% GLH8NDESix administration both eyes, each 2 drop in Korean |
| The C group in placebo | Placebo comparator | Drug: PlacebosSix administration both eyes, each 2 drop in Korean |
| The D group in 5% GLH8NDE | Experimental | Drug: 5% GLH8NDESix administration both eyes, each 2 drop in Caucasian |
| The D group in placebo | Placebo comparator | Drug: PlacebosSix administration both eyes, each 2 drop in Caucasian |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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 a history of drug abuse or a positive urine drug screening for drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% GLH8NDE5% GLH8NDE as eye drops | Drug | The A group in 5% GLH8NDE, The B group in 5% GLH8NDE, The C group in 5% GLH8NDE, The D group in 5% GLH8NDE |
| PlacebosPlacebo as eye drops | Drug | The A group in placebo, The B group in placebo, The C group in placebo, The D group in placebo |
Primary outcome
Adverse events
Time frame: Between 1 day before first IP administration and 18 days
To 18 days after first IP administration
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)
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
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
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
Clinical laboratories in blood sample
Time frame: Each point at day 1, 2, 4, 6, 8, 10, and 11
Whether abnormal blood chemistry
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
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
Ophthalmic symptom
Time frame: Each point at Day 1, 2, 4, 6, 8, 10, and 11
To 18 days after first IP administration
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MinChang Kwon, Ph. D study director
GL PharmTech Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5% GLH8NDE in people with Dry Eye Syndromes, run by GL Pharm Tech Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Between 1 day before first IP administration and 18 days). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.