Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers
Condition: Healthy
Intervention: hzVSF-v13; Placebo
Intervention description: Dosage form: 10mg / 20mg / 50mg / 100mg / 200mg / 400mg / 800mg / 1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Frequency: Dose at Day 1 (single administration); Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1 (single administration)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: Male
Minimum age: 19 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the safety/tolerability and pharmacokinetic characteristics after single
      intravenous (IV) administration of hzVSF-v13 (humanized Virus Suppressing Factor-variant 13)
      in healthy male volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males aged 19 to 45 years at the time of the screening visit

          -  Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55
             kg and less than 90 kg at the time of the screening visit

          -  Individuals deemed clinically healthy based on medical history, physical examination,
             vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests
             (provided that individuals outside the normal range may participate subject to
             investigator discretion)

          -  Individuals who have agreed to use a medically acceptable method of dual contraception
             and not to donate sperm from the first day until 30 days after the last day of
             investigational product administration

          -  Individuals who have voluntarily decided to participate in this clinical study and
             have given written consent to comply with the requirements of the study

        Exclusion Criteria:

          -  Individuals with a clinically significant hepatic, renal, digestive, respiratory,
             musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic,
             cardiovascular, or other disease or history

          -  Individuals with a clinically significant history of sensitivity to the components of
             hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin,
             non-steroidal anti-inflammatory drugs, antibiotics, etc.)

          -  Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during
             screening

          -  Individuals who have a history of drug abuse, or who turns out "positive" in test for
             abuse-likely drugs in the urine drug screening test

          -  Individuals with abnormal results for any of the following vital signs at the time of
             the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic
             blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm

          -  Individuals with abnormal results for any of the following ECG items at the time of
             the screening visit A. PR (Pulse rate): > 210 msec B. QRS complex : > 120 msec * QRS
             complex is the name for the combination of three of the graphical deflections seen on
             a typical electrocardiogram (EKG or ECG) C. QTc (Corrected QT interval): > 450 msec

          -  Individuals who have participated in another clinical study or bioequivalence study in
             the 3 months prior to the first day of administration

          -  Individuals who have donated whole blood within the 2 months prior to the first day of
             administration, or donated blood components or received blood within the 1 month prior
             to the first day of administration

          -  Individuals who have taken barbitals or other drug-metabolizing enzyme inducers or
             inhibitors within the 1 month prior to screening

          -  Individuals who have consumed grapefruit or caffeine-containing foods within 3 days of
             the first administration, and individuals who are unable to avoid consuming
             grapefruit-containing foods from 3 days prior to admission until the date of discharge

          -  Individuals who have taken prescription drugs or oriental medications within 2 weeks
             prior to the first day of administration, or who have taken over-the-counter (OTC)
             drugs within the 1 week prior to the first day of administration (provided that
             individuals who meet other requirements may participate in the clinical study subject
             to investigator discretion)

          -  Individuals who consume high amounts of caffeine or alcohol and individuals who are
             heavy smokers (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL of pure
             alcohol), smoking > 10 cigarettes/day)

          -  Individuals who are unable to eat meals provided by the institution

          -  Individuals who have participated in the present study

          -  Individuals who test positive (for hepatitis B, human immunodeficiency virus (HIV),
             hepatitis C) on serological testing

          -  Individuals with veins that are not suitable for intravenous catheter insertion or
             multiple venipunctures

          -  Individuals who do not agree to use a medically acceptable method of dual
             contraception from the first day until 30 days after the last day of investigational
             product administration

          -  Other individuals deemed unsuitable as a subject by an investigator