Healthy Volunteers Clinical Trial
Official title:
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
Verified date | September 2021 |
Source | Intron Biotechnology, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single dose of N-Rephasin® SAL200 in healthy male subjects.
Status | Completed |
Enrollment | 36 |
Est. completion date | February 7, 2014 |
Est. primary completion date | February 7, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Intron Biotechnology, Inc. |
Korea, Republic of,
Fischetti VA. Bacteriophage lysins as effective antibacterials. Curr Opin Microbiol. 2008 Oct;11(5):393-400. doi: 10.1016/j.mib.2008.09.012. Epub 2008 Oct 14. Review. — View Citation
Loeffler JM, Nelson D, Fischetti VA. Rapid killing of Streptococcus pneumoniae with a bacteriophage cell wall hydrolase. Science. 2001 Dec 7;294(5549):2170-2. — View Citation
Loessner MJ. Bacteriophage endolysins--current state of research and applications. Curr Opin Microbiol. 2005 Aug;8(4):480-7. Review. — View Citation
Schellekens H. Immunogenicity of therapeutic proteins. Nephrol Dial Transplant. 2003 Jul;18(7):1257-9. Review. — View Citation
Wu JA, Kusuma C, Mond JJ, Kokai-Kun JF. Lysostaphin disrupts Staphylococcus aureus and Staphylococcus epidermidis biofilms on artificial surfaces. Antimicrob Agents Chemother. 2003 Nov;47(11):3407-14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pharmacokinetic Parameters After Single IV Administration of N-Rephasin® SAL200 [Effective t1/2 (h)] | 0, 4, 8, 12, 16, 20, 24 hours post-dose | ||
Other | Pharmacodynamics Evaluation of N-Rephasin® SAL200 : Mean Concentration of Bactericidal Activity After Single Dose of N-Rephsin® SAL200 IV Administration | up to 2hours | ||
Other | Pharmacokinetic Evaluation of N-Rephasin® SAL200 at the Administered Doses by Analysis of Concentration of N-Rephasin® SAL200 in Serum [Cmax (µg/ml)] | Day 1 to 2 | ||
Other | Pharmacokinetic Evaluation of N-Rephasin® SAL200 at the Administered Doses by Analysis of Concentration of N-Rephasin® SAL200 in Serum [Cmax/D (µg/ml/mg)] | Day 1 to 2 | ||
Other | Pharmacokinetic Evaluation of N-Rephasin® SAL200 at the Administered Doses by Analysis of Concentration of N-Rephasin® SAL200 in Serum [AUC Last (µg*h/ml)] | Day 1 to 2 | ||
Primary | Evaluation of the Safety of N-Rephasin® SAL200 in Healthy Human Volunteers | Up to 50 days after administration |
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