A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers
NCT ID: NCT01855048
Last Updated: 2021-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2013-08-06
2014-02-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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N-Rephasin® SAL200
N-Rephasin® SAL200, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg
N-Rephasin® SAL200
continuous intravenous infusion over 60 minutes
INT200-Placebo
Placebo
INT200-Placebo
Formulation buffer for continuous intravenous infusion over 60 minutes
Interventions
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N-Rephasin® SAL200
continuous intravenous infusion over 60 minutes
INT200-Placebo
Formulation buffer for continuous intravenous infusion over 60 minutes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
45 Years
MALE
Yes
Sponsors
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Intron Biotechnology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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In Jin Jang, M.D., Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Loessner MJ. Bacteriophage endolysins--current state of research and applications. Curr Opin Microbiol. 2005 Aug;8(4):480-7. doi: 10.1016/j.mib.2005.06.002.
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.
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. doi: 10.1126/science.1066869.
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. doi: 10.1128/AAC.47.11.3407-3414.2003.
Schellekens H. Immunogenicity of therapeutic proteins. Nephrol Dial Transplant. 2003 Jul;18(7):1257-9. doi: 10.1093/ndt/gfg164. No abstract available.
Jun SY, Jang IJ, Yoon S, Jang K, Yu KS, Cho JY, Seong MW, Jung GM, Yoon SJ, Kang SH. Pharmacokinetics and Tolerance of the Phage Endolysin-Based Candidate Drug SAL200 after a Single Intravenous Administration among Healthy Volunteers. Antimicrob Agents Chemother. 2017 May 24;61(6):e02629-16. doi: 10.1128/AAC.02629-16. Print 2017 Jun.
Related Links
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FDA, Guidance for Industry, Estimating the Maximum Safe Starting Dose inInitial Clinical Trials for Therapeutics in Adult Healthy Volunteers, 2005.
Other Identifiers
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SAL200-1A
Identifier Type: -
Identifier Source: org_study_id