Phase I Trial of a Single Dose of CRS3123

Summary

Double-blind, randomized, placebo-controlled Phase I Trial to determine the safety and pharmokinetics of a single dose of CRS3123 in healthy adult volunteers. Forty healthy male and female subjects 18 to 45 years will be admitted in 5 dosing Cohorts, 8 subjects per Cohort. Up to two alternates may be used per dosing Cohorts for study subjects that drop out. The primary objective of the study is to determine the safety and tolerability of escalating doses of CRS3123 following oral administration to healthy subjects.

Timeline

Start

2012-05-22

Primary completion

2014-04-07

Completion

2014-04-21

Publications

• Nayak SU, Griffiss JM, Blumer J, O'Riordan MA, Gray W, McKenzie R, Jurao RA, An AT, Le M, Bell SJ, Ochsner UA, Jarvis TC, Janjic N, Zenilman JM. Safety, Tolerability, Systemic Exposure, and Metabolism of CRS3123, a Methionyl-tRNA Synthetase Inhibitor Developed for Treatment of Clostridium difficile, in a Phase 1 Study. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e02760-16. doi: 10.1128/AAC.02760-16. Print 2017 Aug.

Drugs

Indications