A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers
Condition: Healthy Volunteers; Anti-Bacterial Agents; Methicillin-Resistant Staphylococcus Aureus; Methicillin-Sensitive Staphylococcus Aureus Infection
MeSH terms: Staphylococcal Infections; Hypersensitivity
Intervention: N-Rephasin® SAL200; INT200-Placebo
Intervention description: continuous intravenous infusion over 60 minutes; Formulation buffer except active ingredient for continuous intravenous infusion over 60 minutes
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Methicillin-Resistant Staphylococcus Aureus; Methicillin-Sensitive Staphylococcus Aureus; N-Rephasin SAL200

Summary:

      To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of N-Rephasin®
      SAL200 following single and multiple ascending doses in healthy male volunteers after
      continuous intravenous infusion over 60 minutes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects aged between 20 and 45 years at screening

          -  Those whose body weight is between 50kg and 90kg, and BMI is between 18.0 and 27.0

          -  Subjects who have fully understood this clinical trial via detailed explanation, are
             willing to voluntarily participate in this study, and agree to give written informed
             consent and to follow all of trial-related rules.

        Exclusion Criteria:

          -  Those who have clinically significant liver, kidney, nervous system, endocrine system,
             respiratory system, hemato-oncology, cardiovascular system, mental diseases or past
             history.

          -  Those who have been diagnosed or suspected infectious disease within 30 days prior to
             the first dose of study medication

          -  Those who have history of hypersensitivity to drugs containing N-Rephasin® SAL200 or
             other drugs (aspirin and antibiotics)

          -  Those who have taken other drugs containing N-Rephasin® SAL200.

          -  Those who are antibody-positive to N-Rephasin® SAL200

          -  Those who have SBP <90mmHg or DBP <50mmHg (otherwise SBP > 150mmHg or DBP > 100mmHg)
             in vital signs, when measured after a 3-minute rest in sitting position.

          -  Those who have medical history of drug abuse or positive to urine drug screening

          -  Has taken any prescription drugs or herbal medicines within 14 days prior to first
             dose of study medication; otherwise, has taken over-the-counter drugs or vitamins
             within 7 days prior to the first dose of study medication (However, if other
             conditions are appropriate upon judgment of the investigator, the subject may
             participate in this study.)

          -  Those who has taken other study medications within 3 months prior to the study
             medication

          -  Those who have donated whole blood within 2 months prior to the first dose of study
             medication or apheresis within 1 month, or received blood transfusion within 1 months
             prior to the first dose of study medication

          -  Those who smoke cigarettes or are found to be nicotine metabolite-positive in
             urinalysis

          -  Those who cannot continuously abstain from drinking alcohol (exceeding 21 units/week,
             1 unit = 10g of pure alcohol) or smoking cigarettes during hospitalization

          -  Those who are judged ineligible for the clinical study by the investigator due to
             other reasons, including the results of clinical laboratory tests

          -  Those who do not agree to use medically accepted contraceptive measures for 60 days
             after the first dose of study medication, or those who are unwilling to report the
             partner's pregnancy until 90 days after the first dose of study medication