A study to compare SPR206 levels in the blood and lungs
Research type
Research Study
Full title
A Phase 1, Single-Centre, Open-Label Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 by comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations following the Intravenous Administration of SPR206 in Healthy Volunteers
IRAS ID
294111
Contact name
Dave Singh
Contact email
Sponsor organisation
Spero Therapeutics, Inc.
Eudract number
2020-006019-52
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Summary of Research
SPR206 is a new experimental antibiotic, for the purpose of treating infections of the urinary tract, lungs and blood stream caused by drug-resistant bacteria.
The purpose of this study is to compare the levels of SPR206 in the lungs and blood. To do this blood samples will be taken to measure levels of SPR206 in participants blood and a bronchoscopy using a flexible fibreoptic scope, is performed to measure levels of SPR206 in participants lungs. SPR206 is hoped to help patients who have acquired an infection that is resistant to multiple antibiotics used to treat such infections.
There will be 5 groups (cohorts) of the study, each containing 6 participants. The difference between these groups is the time of the bronchoscopy on Day 2. Subjects will participate in only 1 cohort.
SPR206 will be given by intravenous infusion (into a vein in the arm) over approximately 60 minutes. Participants will receive a total of three doses each given 8 hours apart.
Summary of Results
Administration of 3 doses of SPR206 100 mg IV was well tolerated and generally safe with no SAEs or deaths and no clinically significant abnormalities observed in laboratory parameters, vital signs, ECG assessments, or physical examination.
The results of this study provided important information on intrapulmonary PK of SPR206 in healthy subjects. SPR206 achieved lung exposures consistent with predicted therapeutic levels, when administered three times daily at 100 mg. Results showed that SPR206 had a mean lung epithelial lining fluid (ELF) to plasma concentration ratio of 0.264, with area under the curve (AUC) from 0-8 hours used to estimate the total uptake of SPR206. Importantly, the mean concentration of SPR206 in the lung ELF exceeds the SPR206 MIC (minimum inhibitory concentration) for targeted gram-negative pathogens for the entirety of the 8-hour dosing period.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0023
Date of REC Opinion
19 Feb 2021
REC opinion
Favourable Opinion