A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

December 18, 2018

Primary Completion Date

December 23, 2019

Study Completion Date

December 23, 2019

Conditions
Healthy Volunteers
Interventions
DRUG

SPR206

"SAD Cohorts: Double-blind dosing will occur in Cohorts 1 - 8. Six participants will receive single doses of SPR206. The dose escalation steps may be altered following review of the safety data upon completion of each cohort.~MAD Cohorts: Double blind dosing will occur in Cohorts 9 - 13. Six participants in each cohort will receive multiple doses of SPR206. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. 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 7 consecutive days for Cohorts 9 - 12 and for a total of 14 consecutive days for Cohort 13."

DRUG

Placebo

0.9% sodium chloride for injection. SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo.

Trial Locations (1)

2031

Scientia Clinical Research Ltd., Randwick

All Listed Sponsors
collaborator

Clinical Network Services (CNS) Pty Ltd

INDUSTRY

lead

Spero Therapeutics

INDUSTRY