Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2016-02-29
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HL036 0.5mg/ml
Administration : 2 times per day for one day
HL036
Vehicle
HL036 5mg/ml
Administration : 2 times per day for one day
HL036
Vehicle
Interventions
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HL036
Vehicle
Eligibility Criteria
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Inclusion Criteria
* Healthy Korean males volunteers who are 20 to 50 years old at screening procedure
Exclusion Criteria
* 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 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
20 Years
50 Years
MALE
Yes
Sponsors
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HanAll BioPharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
Seoul, , South Korea
Countries
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Other Identifiers
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HTR15I_1
Identifier Type: -
Identifier Source: org_study_id