64
Participants
Start Date
December 31, 2016
Primary Completion Date
July 31, 2017
Study Completion Date
September 30, 2017
SPR741
"SAD: Double-blind dosing will occur in cohorts 1 through 8. Six participants will receive single doses of SPR741. The dose escalation steps may be altered following review of the safety data upon completion of each cohort.~MAD: The Safety Management Group will evaluate the safety and tolerability data obtained for the participants in Cohorts 1-5 to determine the appropriate dose level of intravenous q8h dosing of SPR741 to be utilized in the first cohort (Cohort 9) in the MAD. Dosing will commence on the morning of Day 1. Three doses will be administered per day at approximately 8 hours apart. Daily dosing will continue for a total of 14 consecutive days."
Placebo
0.9% sodium chloride for injection. SAD: Two participants in each cohort will receive matching placebo. MAD: Two participants in each cohort will receive matching placebo.
CMAX - A division of IDT Australia, Limited, Adelaide
Lead Sponsor
CPR Pharma Services Pty Ltd, Australia
INDUSTRY
Spero Therapeutics
INDUSTRY