NCT01855048 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
Loessner MJ
Bacteriophage endolysins--current state of research and applications. Curr Opin Microbiol. 2005 Aug;8(4):480-7. Review.
Schellekens H
Immunogenicity of therapeutic proteins. Nephrol Dial Transplant. 2003 Jul;18(7):1257-9. Review.
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.

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

Details for clinical trial NCT01855048

Clinical trial NCT01855048 - References