A safety study of AL-794
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of repeated dosing regimens of AL-794 in healthy volunteers (17-012)
IRAS ID
238502
Contact name
Adeep Puri
Contact email
Sponsor organisation
Alios BioPharma
Eudract number
2017-004193-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (AL-794) is an experimental medicine for treating influenza (‘flu’). We hope that the study medicine will work by blocking a substance that the flu virus uses to multiply itself. The study medicine works differently compared to existing flu treatments in that it could be combined with current flu medicines to make them more effective, so we hope it will treat more types of flu.\n\nWe’ll test repeated doses of AL-794, twice-daily, for 5 days, to find out its side effects and the blood levels of its breakdown products. We’ll also test whether food affects blood levels of AL-794 or its breakdown products in women.\n\nWe’ll enrol up to 236 healthy men and women, aged 18-60, in 3 groups of 12 volunteers each (2 groups of women and 1 of men) in Part 1 and up to 200 volunteers in Part 2. In Part 1, 1 group of 12 women will take AL-794 without food. All other volunteers in Parts 1 and 2 will take AL-794 with food.\n\nDepending on the results, we might ask the volunteers to take the study medicine for up to 10 days; or to take a lower dose for three or four times a day. \n\nParticipants will take up to 6 weeks to finish the study. They’ll make 2 outpatient visits and stay on the ward for up to 7 nights in total. \n\nA pharmaceutical company (Alios Biopharma) is funding the study.\n\nThe study will take place at 1 centre in London, but more centres may be added if required.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0657
Date of REC Opinion
2 Jan 2018
REC opinion
Favourable Opinion