A Phase I Study of HY209 Gel in Healthy Male Volunteers for Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: HY209
Intervention description: 6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double blind, placebo-controlled, single and multiple dosing, dose escalation study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: Male
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: atopic dermatitis

Summary:

      A randomized, double-blind, placebo-controlled single and multiple dosing, dose escalation
      phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209
      gel after transdermal administration in healthy male volunteers as a possible treatment
      option for atopic dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male aged from 20 to 50 at screening test

          -  Weight 45kg ~ 90kg with BMI 17kg/m2 ~ 27kg/m2

          -  No skin diseases, no skin damages(scars, tattoo, etc), no hairy skin

        Exclusion Criteria:

          -  Those who have a history of hypersensitivity or clinically significant
             hypersensitivity reactions to generic drugs (aspirin, antibiotics, etc.)

          -  Those who have clinically significant liver, kidney, respiratory, endocrine,
             neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic
             diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary
             artery disease, Congestive heart failure, arrhythmia, cerebrovascular disease, etc.)
             or who have a history of those diseases

          -  Those who had clinical symptoms suspected of acute infectious disease within 2 weeks
             before the scheduled date of the first administration, or whose temperature measured
             by the screening test (eardrum) was 38.0 ° C or higher

          -  Those who have taken any prescription drugs, herbal medicines, crude drugs within 2
             weeks before the scheduled date of administration of the medicines for clinical trials
             , or over-the-counter medicines or vitamin preparations within 1 week.

          -  Those who have a history of substance abuse, or positive urine screening tests
             (cannabinoid, opiates, amphetamine, cocaine, barbiturate, benzodiazepine)

          -  Those who have a history of smoking within 3 months (However, if they quit smoking
             three months before the first scheduled medication, they are eligible for selection)

          -  Those who have been found to be positive in serological tests (HBs antigen, hepatitis
             C virus antibody and HIV antibody)

          -  Those who drink continuously (above 21 units / week, 1 unit = 10 g of pure alcohol)

          -  Those who have been taking medicines by participating in other clinical trials or
             bioequivalence studies within 3 months prior to the date of first dosing

          -  Those who have been bleeding, blood drawings or blood donation of 400mL or more within
             8 weeks before the scheduled date of administration of the drug for clinical trials

          -  Those who have vital signs measured at sitting position after the break for more than
             3 minutes,

               -  Low blood pressure (systolic blood pressure <90 mmHg, diastolic blood pressure
                  <50 mmHg)

               -  High blood pressure (systolic blood pressure greater than 150 mmHg, diastolic
                  blood pressure greater than 100 mmHg)

          -  Test subjects who are deemed unsuitable for participating in clinical trials due to
             clinical laboratory tests, ECG results, or other reasons