Abstract
KW-1070, a new aminoglycoside antibiotic, was administered intramuscularly to seven healthy adult volunteers to study its safety and pharmacokinetics.
In single dose studies, volunteers were administered 4mg/kg or 8mg/kg of KW-1070. In multiple dose studies, volunteers received 4mg/kg of KW-1070 every 12 hours for 5 days.
No side effect or abnormal laboratory findings were found in either the single or multiple dose studies.
The serum level of KW-1070 peaked at 10.08μg/ml after one hour in the 4mg/kg dose group, and at 15.90μg/ml after 30 minutes in the 8mg/kg dose group. The serum level decreased gradually, and the concentration after 8 hours was 1.07μg/ml for the 4mg/kg dose group and 2.34μg/ml for the 8mg/kg dose group.
The serum half-life of KW-1070 was 1.95 hours for the 4mg/kg dose group, and 2.35 hours for the 8mg/kg dose group, which indicates that dose response is dependent on the dose level. The urinary recovery rate 12 hours after administration was 53.0% for the 4mg/kg dose group and 62.5% for the 8mg/kg dose group. No significant differences were observed in absorption or excretion rates between single and multiple administrations of KW-1070 to healthy adult volunteers.