NCT02717208

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 9, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

February 18, 2016

Last Update Submit

December 7, 2016

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    1 week

Secondary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    24 hours

  • Area under the plasma concentration versus time curve (AUC)

    24 hours

Study Arms (2)

HL036 0.5mg/ml

ACTIVE COMPARATOR

Administration : 2 times per day for one day

Biological: HL036Biological: Vehicle

HL036 5mg/ml

ACTIVE COMPARATOR

Administration : 2 times per day for one day

Biological: HL036Biological: Vehicle

Interventions

HL036BIOLOGICAL
HL036 0.5mg/mlHL036 5mg/ml
VehicleBIOLOGICAL
HL036 0.5mg/mlHL036 5mg/ml

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 23, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

December 9, 2016

Record last verified: 2016-02

Locations

KR(1)