SODIUM N-[2-[4-(2, 2-DIMETHYLPROPIONYLOXY)PHENYLSULFONYLAMINO]BENZOYL]AMINOACETATE TETRAHYDRATE(ONO-5046·Na)(2)4-WEEK REPEATED DOSE INTRAVENOUS TOXICITY STUDY IN RATS WITH 4-WEEK RECOVERY TEST

Abstract

A 4-week repeated dose toxicity study with 4-week recovery test of sodium N-[2-[4-(2, 2-dimethylpropionyloxy)phenylsulfonylamino]benzoyl]aminoacetate tetrahydrate(ONO-5046·Na), a novel neutriphil elastase inhibitor, was conducted in Sprague-Dawley(SD)rats.The rats of both sexes were administered ONO-5046·Na intravenously at a daily dose of 0(vehiclr control and saline control), 18.75, 37.5, 75 or 150 mg/kg. ONO-5046·Na did not affect clinical signs, body weight, food consumption, ophthalmology, urinalysis, hematology, blood chemistry, organ weights, necropsy or histopathology at any dose. These results indicate that the NOAEL of ONO-5046·Na in rats is 150 mg/kg/day for both sexes in this study.