Pharmacokinetics of the phage endolysin‐based candidate drug SAL200 in monkeys and its appropriate intravenous dosing period

Summary SAL 200 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 SAL 200 and to assess the safety of a short SAL 200 dosing period (<1 week). Maximum serum drug concentrations and systemic SAL 200 exposure were proportional to the dose and comparable in male and female monkeys. SAL 200 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.