Dry Eye
Conditions
Brief summary
To evaluate the safety, local tolerability and pharmacokinetic characteristics after administration of eye-drop HL036 in healthy Korean male volunteers
Detailed description
A total of 10 subjects will be dosed in each group with subjects randomized 8:2 to HL036 or placebo. Three of 10 subjects will be randomized to the sentinel dosing in each group. A safety data review as masking will be performed for 3days prior to the other subjects treatment. Treatment of high dose will proceed following a review of safety data from low dose.
Interventions
BIOLOGICALHL036
BIOLOGICALVehicle
Sponsors
HanAll BioPharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) | 24 hours |
| Area under the plasma concentration versus time curve (AUC) | 24 hours |
Countries
South Korea
Outcome results
None listed