Phase 1 Study for Safety and Tolerability of HL036

Dry Eye Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717208
• Other study ID #: HTR15I_1
• Status: Completed
• Phase: Phase 1
• First received: February 18, 2016
• Last updated: December 7, 2016
• Start date: February 2016
• Est. completion date: June 2016

Study information

• Verified date: February 2016
• Source: HanAll BioPharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety, local tolerability and pharmacokinetic characteristics after administration of eye-drop HL036 in healthy Korean male volunteers

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

? History of ocular disease including keratitis, uveitis, retinitis, dry eye, strabismus or had suspected symptoms or signs

? Subjects who are under 20/40 of corrected visual acuity at screening

? Subjects with a history of ocular surgery ( including subjects who had laser surgery in the previous 6 month from screening)

? Subjects who had contact lens wear within 1 month or had side effects after wearing, unwilling to discontinue wear during the study period

? 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye

Intervention

Biological:
• HL036

• Vehicle

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HanAll BioPharma Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		1 week	Yes
Secondary	Peak Plasma Concentration (Cmax)		24 hours	Yes
Secondary	Area under the plasma concentration versus time curve (AUC)		24 hours	Yes