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Phase 1 Study for Safety and Tolerability of HL036

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717208
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
HanAll BioPharma Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 18, 2016
First Posted Date  ICMJE March 23, 2016
Last Update Posted Date December 9, 2016
Study Start Date  ICMJE February 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
Adverse Events [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
  • Peak Plasma Concentration (Cmax) [ Time Frame: 24 hours ]
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study for Safety and Tolerability of HL036
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • Biological: HL036
  • Biological: Vehicle
Study Arms  ICMJE
  • Active Comparator: HL036 0.5mg/ml
    Administration : 2 times per day for one day
    Interventions:
    • Biological: HL036
    • Biological: Vehicle
  • Active Comparator: HL036 5mg/ml
    Administration : 2 times per day for one day
    Interventions:
    • Biological: HL036
    • Biological: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 22, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02717208
Other Study ID Numbers  ICMJE HTR15I_1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party HanAll BioPharma Co., Ltd.
Study Sponsor  ICMJE HanAll BioPharma Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account HanAll BioPharma Co., Ltd.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP