Phase 2a single blind study of multiple PC786 doses against RSV
Research type
Research Study
Full title
A single-blind, placebo controlled, randomised study to evaluate antiviral activity and safety and pharmacokinetics of inhaled PC786 against respiratory syncytial virus (RSV) in healthy adult subjects in a virus challenge model.
IRAS ID
230527
Contact name
Bryan Murray
Contact email
Sponsor organisation
Pulmocide Limited
Eudract number
2017-002563-18
Duration of Study in the UK
0 years, 4 months, days
Research summary
Respiratory Syncytial Virus (RSV) is one of the viruses that causes the common cold, but it can result in serious respiratory problems in infants, the elderly and anyone with a low resistance to infection. PC786, the study drug, has been developed for the treatment of RSV infection by interfering with the way the virus multiplies.
This study is a phase 2a randomised, single-blind, repeat dose study to evaluate the antiviral effect, safety and tolerability of PC786 and assess how the human body deals with the study drug (this is called Pharmacokinetics). Healthy adults will be infected with RSV in an established experimental quarantine unit, then administered the study drug PC786 or a placebo (dummy drug) as an inhaled formulation using facemask delivery.
The study will be conducted in a single centre and will include multiple quarantine sessions where 56 Volunteers will be admitted in groups.
The study consists of 3 parts:
1) Screening will take place up to 90 days before quarantine where volunteers will be asked to complete an informed consent and undergo scheduled assessments to determine their eligibility.
2) The Quarantine (Challenge) Phase is where volunteers who are eligible will be admitted on Day-2. Further assessments will be undertaken to ensure subject suitability. Once confirmed, volunteers will be inoculated with RSV on Day 0 and will be randomly selected to receive twice daily doses of PC786 10mg or a placebo for 5 days (10 doses in total will be given).
3) Following discharge (Day 12), volunteers will be asked to return for a follow up visit on Day 28(± 3 days) to assess their wellbeing, and any ongoing symptoms.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0488
Date of REC Opinion
9 Oct 2017
REC opinion
Further Information Favourable Opinion