- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02717208
Phase 1 Study for Safety and Tolerability of HL036
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Local Tolerability and Pharmacokinetic Characteristics After Administration of Eye-drop HL036 in Healthy Korean Male Volunteers (Phase I)
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who listened to the description about characteristics of this clinical trial and signed the IRB approved consent form before the whole screening tests
- Healthy Korean males volunteers who are 20 to 50 years old at screening procedure
Exclusion Criteria:
- Subjects who have a history of tuberculosis or have a positive Quantiferon Test
- Subjects who have treated live vaccine within 8 weeks prior to the first day of dosing or have a plan to treat it before the end of study
- Subjects who have presence or history of significant hepatic(including hepatitis B or C) , renal, neurological, immunological, respiratory , endocrine or hemato•oncology, cardiovascular, psychiatric disease
Subjects who have presence or history of ophthalmological examination by the following
① History of ocular disease including keratitis, uveitis, retinitis, dry eye, strabismus or had suspected symptoms or signs
② Subjects who are under 20/40 of corrected visual acuity at screening
③ Subjects with a history of ocular surgery ( including subjects who had laser surgery in the previous 6 month from screening)
④ Subjects who had contact lens wear within 1 month or had side effects after wearing, unwilling to discontinue wear during the study period
⑤ Abnormalities following other ophthalmological examination
- Subjects who have a history of allergy to anti-TNF drug(infliximab, adalimumab, etanercept) or any similar product
- Subjects who had a history of drug abuse or a positive of drug abuse at urine test
- Subjects who have taken any prescribed drugs, herbal agents within 2 weeks or who have taken any over-the-counter (OTC) drugs including artificial tears or vitamins within 1 week prior to the first day of dosing (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
- Subjects who have participated in another clinical trial or bioequivalence research with an IP within 3 months prior to the first day of dosing.
- Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month prior to the first day of dosing.
- Subjects who have currently drinks in excess of 21 units per week(1 unit = 10 g of pure alcohol) or would not be able to stop drinking alcohol during the study
- Subjects who have smoked in the 6 months or has used nicotine product or would not be able to stop smoking during the hospitalization Subjects who planned pregnancy or cannot use established contraceptions (e.g. infertility operation of the subject or partner, intrauterine contraceptive device of the partner, barrier contraception, diaphragm or condom use in combination during the test
- Subject who are judged as inappropriate for participating in the clinical trial by researcher because of causes including the test result of clinical laboratory
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: HL036 0.5mg/ml
Administration : 2 times per day for one day
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Active Comparator: HL036 5mg/ml
Administration : 2 times per day for one day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events
Time Frame: 1 week
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1 week
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak Plasma Concentration (Cmax)
Time Frame: 24 hours
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24 hours
|
Area under the plasma concentration versus time curve (AUC)
Time Frame: 24 hours
|
24 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTR15I_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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