title: Pharmacokinetics of the phage endolysin-based candidate drug SAL200 in monkeys and its appropriate intravenous dosing period.
abstract: SAL200 is a new phage endolysin-based candidate drug for the treatment of staphylococcal infections. An intravenous administration study was conducted in monkeys to obtain pharmacokinetic information on SAL200 and to assess the safety of a short SAL200 dosing period (<1 week). Maximum serum drug concentrations and systemic SAL200 exposure were proportional to the dose and comparable in male and female monkeys. SAL200 was well tolerated, and no adverse events or laboratory abnormalities were detected after injection of a single dose of up to 80 mg/kg per day, or injection of multiple doses of up to 40 mg/kg per day.
authors.affiliation: iNtRON Biotechnology, Inc., Seongnam-si, Gyeonggi-do, Korea.
authors.forename: Soo Youn
authors.initials: SY
authors.lastname: Jun
authors.affiliation: iNtRON Biotechnology, Inc., Seongnam-si, Gyeonggi-do, Korea.
authors.forename: Gi Mo
authors.initials: GM
authors.lastname: Jung
authors.affiliation: iNtRON Biotechnology, Inc., Seongnam-si, Gyeonggi-do, Korea.
authors.forename: Seong Jun
authors.initials: SJ
authors.lastname: Yoon
authors.affiliation: Korea Institute of Toxicology, General and Applied Toxicology Center, Daejeon, Korea.
authors.forename: So Young
authors.initials: SY
authors.lastname: Youm
authors.affiliation: Korea Institute of Toxicology, General and Applied Toxicology Center, Daejeon, Korea.
authors.forename: Hyoung-Yun
authors.initials: HY
authors.lastname: Han
authors.affiliation: Korea Institute of Toxicology, General and Applied Toxicology Center, Daejeon, Korea.
authors.forename: Jong-Hwa
authors.initials: JH
authors.lastname: Lee
authors.affiliation: iNtRON Biotechnology, Inc., Seongnam-si, Gyeonggi-do, Korea.
authors.forename: Sang Hyeon
authors.initials: SH
authors.lastname: Kang
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D001435:Bacteriophages; D004305:Dose-Response Relationship, Drug; D010450:Endopeptidases / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D005260:Female; D000882:Haplorhini; D007262:Infusions, Intravenous; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects* / Q000502:physiology; D000071059:Phage Therapy / Q000379:methods*; D013203:Staphylococcal Infections / Q000188:drug therapy / Q000378:metabolism
chemical_list: D000900:Anti-Bacterial Agents; D010450:Endopeptidases; C001143:endolysin
keywords: antibiotic resistant; intravenous administration; monkey; phage endolysin; staphylococci