A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers

This is an interventional treatment trial for Healthy Volunteers focused on measuring N-Rephasin® SAL200, endolysin, Placebo Read More

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.