Safety and blood levels of F901318, version 1
Research type
Research Study
Full title
F901318 - A phase I, double-blind, placebo controlled, single and multiple ascending intravenous dose, safety, tolerability and pharmacokinetic study in healthy male subjects
IRAS ID
171311
Contact name
Frans Van Den Berg
Contact email
Sponsor organisation
F2G Ltd
Eudract number
2014-004536-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
F901318 is an experimental new treatment for serious fungal infections, which occur when fungal moulds infect body organs, usually the lungs (invasive aspergillosis). Serious fungal infections are rare in healthy people, but patients who have a weakened immune system, such as AIDS or transplant patients, are more at risk of developing them.
Most medicines available to treat serious fungal infections have troublesome side effects or stop working before the infection is fully treated. F901318 works in a different way to existing medicines, so we hope it will work better, and have fewer side effects.
We need to test F901318 in healthy people before it’s tested in patients. We’ll test single and repeated doses of F901318, given by slow injection into a vein, to find out its side effects and blood levels.
The study will be in 3 parts. In each part we’ll include up to 3 groups of 8 healthy men, aged 18–45 years. In each group 2 volunteers will receive placebo instead of F901318.
• Part 1: we’ll test once-daily doses of F901318 for 8 days. We’ll give daily doses that were tested in a previous single-dose study of F901318.
• Optional Part 2A: we’ll test single doses of F901318 only if we plan to test daily doses in Part 2B that are higher than those previously tested.
• Part 2B: we’ll test once- or twice-daily doses of F901318 for 8 days. The daily doses tested will be no higher than doses found to be safe and well tolerated in this or the previous study.Participants will take up to 7 weeks to finish the study. They’ll make 3 outpatient visits, and stay on the ward for up to 13 nights.
A pharmaceutical company (F2G Ltd) is funding the study.
The study will take place at 1 centre in London.
REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0006
Date of REC Opinion
27 Jan 2015
REC opinion
Favourable Opinion