Investigators: Camille Gibson, Chris Blyth, Heidi Hutton, Jan Jones, Jane Jones, Jennifer Kent, Lisa Montgomery, Peter Richmond, Rachel West, Tanya Stoney
Project description
Respiratory Syncytial Virus (RSV) is one of the viruses that cause the ‘common cold’, leading to coughing, fever, sore throat, and a runny nose that usually lasts for about 1-2 weeks. Most babies who get RSV recover fully to normal health after 1-2 weeks, but RSV infection can sometimes worsen and lead to severe cases of chest infection in children.
There are no vaccines approved for the prevention of RSV infection in healthy children. There are no routinely used medications available for the treatment of RSV. Pharmaceutical companies are trying to find new medicines to help these children get better quickly when they are sick with RSV infection.
This is a two part study. The first part of the study requires administration of a Single Ascending dose (SAD) of the medication to the participant and the second part of the study administers multiple ascending doses (MAD) of the medication 12 hourly over 5 days to the participant. The purpose of this research is to look at the effects of the new drug called ALS-008176, which Alios BioPharma Inc. (the Study Sponsor) is developing for use in children infected with RSV.
This study drug is considered an experimental medication as it is still being developed and has not yet been approved for sale by the Regulatory Authorities in the countries where this study is being conducted, including the Therapeutic Good Administration.
ALS-008176 is an antiviral medication (it attacks the RSV virus that causes the infection). It is given by mouth as a liquid. The study drug prevents the virus from dividing and making more copies of itself. In this way, it is hoped that the study drug may control the RSV infection and speed up recovery.
The study drug has been tested in adults who have been infected with RSV. In that study, the drug significantly reduced the amount of virus and also reduced the duration, signs and symptoms of RSV infection.
Partners
- Alios BioPharma Inc.