A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers
Condition: Healthy Volunteers; Anti-Bacterial Agents; Methicillin-Resistant Staphylococcus Aureus
MeSH terms: Staphylococcal Infections
Intervention: N-Rephasin® SAL200; INT200-Placebo
Intervention description: continuous intravenous infusion over 60 minutes; Formulation buffer 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: 36.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: N-Rephasin® SAL200; endolysin; Placebo

Summary:

      The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics
      of single dose of N-Rephasin® SAL200 in healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subject whose age is 20 ~ 45 at the time of screening visit.

          -  Body weight of ≥50kg and <90kg, while within ±20% of the ideal body weight. [ideal
             body weight(kg) = {height(cm)-100}x 0.9]

          -  Subject agreed to participate in the trial and to follow all of trial-related rules
             with a full understanding, after having a full account of the trial

        Exclusion Criteria:

          -  Present disease(s) or medical history(ies) which is(are) clinically significant on
             liver, heart, nervous system, respiratory system, haemato-oncology, cardiovascular or
             psychopathy.

          -  Diagnosed or suspected infectious disease within 30 days in prior to the
             administration.

          -  Clinically significantly allergic to drug(s) containing AI of N-Rephasin® SAL200 or to
             other drugs including aspirin and antibiotics, or has medical history(ies) on such
             allergy.

          -  Already has taken other drug(s) containing AI of N-Rephasin® SAL200.

          -  Positive for Antibody of N-Rephasin® SAL200.

          -  SBP≤90mmHg or DBP≤50mmHg, otherwise, SBP≥150mmHg or DBP≥100mmHg in Vital sign which
             was measured after taking 3 minutes of resting in sitting position.

          -  Has medical history of drug abuse or positive to drug abuse in urine drug screening.

          -  Has taken any prescription drug(s) or herbal medicine(s) within 14 days prior to the
             administration, otherwise, any OTC(Over the counter) (s) or vitamin(s) within 7 days
             prior to the administration(However, can participate in the study if investigator
             makes a decision that the subject can participate regardless the drug taken).

          -  Has taken any other study drugs within 2 months prior to the administration.

          -  Has donated blood(whole blood donation or component transfusion) within (2 months or 1
             month, respectively) in prior to the administration, otherwise, has received blood
             transfusion within 1 month in prior to the administration.

          -  Smoke at present or positive to metabolism of nicotine in urine test.

          -  Drink regularly(over 21 units/week, 1 unit= 10 g of pure alcohol), otherwise, is not
             able to interrupt drinking and smoking in study period.

          -  Investigator made a decision that the subject is not eligible based on results of
             laboratory test or other reason.

          -  Not agree with contraception for 60days after the administration, otherwise,
             notification of pregnancy in case of his partner is pregnant for 90 days after the
             administration.