Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994

PHASE1CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

October 20, 2017

Primary Completion Date

August 2, 2018

Study Completion Date

August 2, 2018

Conditions
Healthy Volunteers
Interventions
DRUG

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."

DRUG

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.

DRUG

Orapenem®

Tebipenem pivoxil granules

Trial Locations (1)

2031

Scientia Clinical Research Ltd, Randwick

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

CPR Pharma Services Pty Ltd, Australia

INDUSTRY

lead

Spero Therapeutics

INDUSTRY

NCT03395249 - Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994 | Biotech Hunter | Biotech Hunter