3 period study of activity and safety of SPR741 with 3 antibiotics
Research type
Research Study
Full title
A Single-center, Multi-arm, Open-label, Randomized, Three- period, Crossover, Phase 1 Study to Evaluate the Drug-drug Interaction, Pharmacokinetics, Safety, and Tolerability of Single Doses of SPR741 Co-administered with Three Different Antibiotics in Healthy Volunteers.
IRAS ID
236071
Contact name
Annelize Koch
Contact email
Sponsor organisation
Spero Therapeutics Inc.
Eudract number
2017-003944-19
Duration of Study in the UK
0 years, 3 months, 18 days
Research summary
In this trial, we are evaluating the safety and potential interactions of a new drug (SPR741) in combination with antibiotics and whether this interaction affects the levels of SPR741 and/or the partner antibiotics in the blood. The drug SPR741 is being developed to help treat bacterial infections, by a company called Spero Therapeutics Inc.
A total of 27 healthy volunteers will be enrolled in 3 treatment arms to receive a single dose of SPR741 alone, a single dose of SPR741 in combination with 1 of the 3 different partner antibiotics (ceftazidime or piperacillin/tazobactam or aztreonam), and a single dose of the partner antibiotic alone in a three-period crossover design. Each arm will enroll nine participants. Each participant will be assigned to only one treatment arm.
All participants will be confined to the clinical facility over 9 days (Day -1 to Day 8). Each of the 3 dosing periods in each arm will be separated by a 2-day washout period.
Some of the most important inclusion criteria are:
- Healthy subjects aged between 18 and 55
- Subjects not taking any medication
- Subjects who are non-smokers or ex-smokers who haven't smoked within 1 month prior to first dose.REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/1792
Date of REC Opinion
31 Oct 2017
REC opinion
Favourable Opinion