AL-794 - first doses in humans; ver 1
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, First-in-human, Study of Orally Administered AL-794 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses, and the Antiviral Activity of Multiple Doses in an Influenza Challenge Study in Healthy Subjects (HMR code 15-017).
IRAS ID
185658
Contact name
Malcolm Boyce
Contact email
Eudract number
2015-002648-15
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine, AL-794, is an experimental new medicine for treating infections with the influenza (‘flu’) virus. We hope that AL-794 will work by blocking a substance that the virus uses to multiply itself. AL-794 works in a different way to existing flu treatments, so we hope it’ll treat more flu types, and that it can be combined with current medicines, to make them more effective.
This is a 4-part study in healthy volunteers, aged 18–60 (Parts 1–3) and 18–55 (Part 4).
In Part 1, we’ll give up to 8 groups of 8 participants single doses of AL-794. It’s never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. We aim to find out its side effects and blood levels. In Group 3, we’ll also test whether food affects blood levels of AL-794 (Part 3).
In Part 2, we’ll test repeated doses of AL-794, in up to 5 groups of 10 participants, to find out its side effects and blood levels. We’ll increase the dose as the study progresses.
In Part 4, we’ll test repeated doses of AL-794 in up to 90 participants, after exposing them to a common strain of flu virus (influenza A, subtype H3N2). We’ll assess side effects and blood levels, and whether AL-794 protects participants from the flu virus.
Participants will take 2–12 weeks to finish the study, depending on the study part. They’ll stay on the ward for:
* 4 nights in Part 1, and 3 extra nights in Part 3
* up to 17 nights in Part 2
* up to 13 nights in Part 4
They’ll also make 3–9 outpatient visits.A pharmaceutical company (Alios BioPharma) is funding the study.
The study will take place at 2 centres in London.
REC name
Wales REC 2
REC reference
15/WA/0199
Date of REC Opinion
6 Aug 2015
REC opinion
Further Information Favourable Opinion