A Phase 2a study of multiple doses of BTA-C585 against RSV infection
Research type
Research Study
Full title
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity Against Respiratory Syncytial Virus Infection, and the Pharmacokinetics of Multiple Oral Doses of BTA-C585 in the Virus Challenge Model
IRAS ID
194226
Contact name
Ralph Campaneria
Contact email
Sponsor organisation
Biota Pharmaceuticals
Eudract number
2015-004296-77
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
This is a Phase 2a, double blind study in which healthy adults will be infected with Respiratory Syncytial Virus (RSV). The volunteers will then be administered with multiple doses of the study drug (orally administered BTA-C585) or a placebo (dummy drug). The study will evaluate the safety and antiviral activity of the study drug and look at how the human body deals with the study drug (this is called pharmacokinetics).
RSV is one of the viruses that causes the common cold, but it can result in serious problems in young babies, including pneumonia and severe breathing problems.
The Sponsor has developed the study drug, which is a selective inhibitor of RSV infection.
Up to 60 subjects across two groups will be examined.
The study consists of 3 parts: Screening, Quarantine Phase and Follow Up.
Screening will take place up to 90 days before quarantine where volunteers will be asked to complete an informed consent and undergo scheduled screening assessments to determine their eligibility.
The Quarantine (Challenge) Phase is where volunteers who are eligible will be admitted to the purpose built quarantine facility in London (Day-2 or Day-1). Further assessments will be undertaken to ensure subject suitability. Once confirmed, volunteers will be inoculated with RSV on Day 0. Once infection is confirmed, subjects will be randomly selected for treatment with study drug or placebo twice daily for 7 days in quarantine. Different doses of the study drug will be studied in cohort (group) 1 and cohort 2.
Following discharge (Day 13), volunteers will be asked to return for a follow up visit on Day 28(± 3 days) for well-being, ongoing symptoms and adverse events. Subjects who begin dosing in the evening of study day 5 will return for a study day 14’follow up’.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0394
Date of REC Opinion
8 Feb 2016
REC opinion
Further Information Favourable Opinion