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

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

Detailed Description
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The purposes of this study are to evaluate the pharmacokinetics, and pharmacodynamics and safety of an experimental intravenous medication, N-Rephasin® SAL200 in healthy male. Participants will include 36 male volunteers. Participants will be grouped according to dosage of N-Rephasin® SAL200 including placebo (0 mg/kg). Study procedures include: check of vital signs, reporting any experienced side effects, physical examination including assessment of the cardiovascular system, and blood sample collection for monitoring of pharmacokinetics, pharmacodynamics and antibody production etc. Participants will be involved in study related procedures for up to 50 days after injection.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Safety, Pharmacokinetics and Phyarmacodynamcs of a Single Intravenous Dose of N-Rephasin® SAL200, in Healthy Male Valunteers

Conditions
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Healthy Volunteers, Anti-Bacterial Agents, Methicillin-Resistant Staphylococcus Aureus

Intervention / Treatment
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* Biological: N-Rephasin® SAL200
* Other: INT200-Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-Rephasin® SAL200<br>N-Rephasin® SAL200, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg | Biological: N-Rephasin® SAL200<br>* continuous intravenous infusion over 60 minutes<br>|
| Placebo Comparator: INT200-Placebo<br>Placebo | Other: INT200-Placebo<br>* Formulation buffer for continuous intravenous infusion over 60 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Safety of N-Rephasin® SAL200 in Healthy Human Volunteers |  | Up to 50 days after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N-Rephasin® SAL200, endolysin, Placebo