Phase 2a Multiple Doses of Orally Administered ALS-008176 against RSV
Research type
Research Study
Full title
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered ALS-008176 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model
IRAS ID
140761
Contact name
Hosnieh Fathi
Contact email
Sponsor organisation
Alios Biopharma
Eudract number
2013-004036-30
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Respiratory syncytial virus, or RSV, infection is a respiratory illness caused by a virus. Anyone can become infected. Typical symptoms resemble the common cold.in adults and older children but can result in serious problems in young babies, including pneumonia and severe breathing problems.
There are no vaccines approved for the prevention of RSV infection and limited treatments to prevent RSV-related hospitalizations in high-risk infants. Furthermore, there are only a few agents in early stages of development for the treatment of RSV infection. Alios Biopharma is developing a novel treatment ALS-008176 that acts by halting the rapid growth of the RSV virus.
This study aims to investigate the effects of this new study drug on the growth of RSV following infection.
There are 3 parts: Screening, Quarantine and Follow Up phases.Volunteers will be assessed for their suitability for inclusion into clinical study.
At the screening visit, volunteers will be fully informed and their consent requested before undergoing any scheduled assessments such as blood test to check the presence of virus antibodies.If volunteers fulfil all eligibility criteria they will be invited to attend the Quarantine Phase which is two days before inoculation (Day -2). During this phase volunteers will be admitted to the purpose built facility in London. Further assessments will be undertaken to ensure subject suitability is maintained from initial visit. Once confirmed, volunteers will be inoculated with RSV and randomly selected for treatment with study drug or placebo for 10 doses.
Volunteers will be regularly monitored and remain in the quarantine unit for 12 days after inoculation or longer if deemed necessary by the study doctor. .
Following discharge (Day 12), volunteers would be asked to return for two follow up visits on Days 16±2 and 28±3 for well-being, ongoing symptoms and adverse events.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0402
Date of REC Opinion
29 Nov 2013
REC opinion
Favourable Opinion