A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

July 31, 2017

Study Completion Date

September 30, 2017

Conditions
Healthy Volunteers
Interventions
DRUG

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."

DRUG

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.

Trial Locations (1)

5000

CMAX - A division of IDT Australia, Limited, Adelaide

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

CPR Pharma Services Pty Ltd, Australia

INDUSTRY

lead

Spero Therapeutics

INDUSTRY

NCT03022175 - A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy Volunteers | Biotech Hunter | Biotech Hunter