ALLECRA - AAI101 and Cefepime [ELF] in Healthy Volunteers
Research type
Research Study
Full title
A Phase I Open-Label, Single-Centre Study to Assess the Concentration of AAI101 and Cefepime in Epithelial Lining Fluid and Plasma in Healthy Volunteers
IRAS ID
221909
Contact name
William Hope
Contact email
Sponsor organisation
Allecra Therapeutics
Eudract number
2017-000097-11
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
There is an urgent need for new, well-tolerated antibiotics active against multidrug-resistant Gram-negative bacteria which are very serious causes of nosocomial infections and infections associated with long-term healthcare facilities (such as nursing homes). At present the options for the treatment of Gram-negative infections, especially multi-drug resistant strains including ESBL producers, are limited. Hence development and availability of new agents to treat these infections are seen as important additions to the existing treatment resources currently available.
This is an open-label, single-centre study designed to evaluate the relationship between the concentration of cefepime in combination with AAI101 (cefepime/AAI101) in bronchial epithelial lining fluid [ELF] (by bronchoalveolar lavage [BAL]) and plasma following a 3-day dosing regimen. AAI101 is active against a wide range of class A and class D β-lactamases [antibiotic resistant bacteria] including ESBLs. The investigational drug has the ability to substantially expand the coverage of existing β-lactams [broad spectrum antibiotics].
Study participants will be healthy male and female subjects aged 18 to 65 years with suitable veins for cannulation or repeated venepuncture; female subjects must be postmenopausal or surgically sterile or with a negative pregnancy test within 1 day prior to study entry. Women of child bearing potential must have a negative urine and/or serum pregnancy test and agree to use highly effective contraception methods during treatment and until after the follow up visit.
This study will be conducted within the Phase 1 accredited Clinical Research Unit based at The Royal Liverpool and Broadgreen University Hospital NHS Trust. The study is expected to start in the 2nd Quarter 2017 and end by 1st Quarter 2018. Participants will attend a Screening visit, have a 5 night residential stay on the Unit and attend 1 follow up visit.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0171
Date of REC Opinion
6 Jun 2017
REC opinion
Further Information Favourable Opinion