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

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.

Timeline

Start

2013-08-06

Primary completion

2014-02-07

Completion

2014-02-07

Publications

• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.

Drugs

Indications