124
Participants
Start Date
October 20, 2017
Primary Completion Date
August 2, 2018
Study Completion Date
August 2, 2018
SPR994
"SAD: Double-blind dosing will occur in all SAD Cohorts except for Cohort 12. In each cohort, six subjects will receive one of five different timed release formulations of SPR994 and 2 subjects will receive placebo. Subjects in SAD Cohorts 2, 3, 6, 16 and 17 will receive a single dose following a 10-h fast. Subjects in SAD Cohorts 1, 8-15 will receive one dose of SPR994 or placebo following a 10-h fast on Day 1 and a second dose following consumption of a standardized meal on Day 7. The dose escalation steps may be altered following review of the safety data of each cohort.~MAD: Double-blind dosing will occur in all MAD Cohorts. Subjects will receive multiple doses of an optimal timed release formulation of SPR994 in MAD Cohort 4 (300 mg) and Cohort 5 (600 mg) or placebo for 14 consecutive days at either BID or TID dosing beginning on Day 1."
Placebo Oral Tablet
Mannitol 200SD SAD: Two subjects in each cohort will receive matching placebo. MAD: Two participants in each cohort will receive matching placebo.
Orapenem®
Tebipenem pivoxil granules
Scientia Clinical Research Ltd, Randwick
Lead Sponsor
CPR Pharma Services Pty Ltd, Australia
INDUSTRY
Spero Therapeutics
INDUSTRY