Single Ascending Dose Safety, Tolerability, and Pharmacokinetics of KBP-7072, a Novel Third Generation Tetracycline

Abstract

Background. KBP-7072 is a novel aminomethylcycline exhibiting broad-spectrum activity against Gram+ and Gram-multidrug resistant bacterial isolates and strains. Methods. This was a randomized, double-blind, placebo-controlled, sequential parallel group, single ascending dose study in healthy adults to evaluate the safety, tol-erability, and pharmacokinetics (PK) of KBP-7072 following oral administration and with an open label food effect panel. Under fasting conditions, 5 fasting cohorts (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) were planned with 8 subjects (6 KBP-7072; 2 placebo) in each cohort. Dose escalation stopped following the 300 mg cohort. An additional 6 subjects received a single oral dose (100 mg) under fed conditions.