PC786 – first doses in humans; version 1
Research type
Research Study
Full title
A randomised, single-blind, placebo-controlled, dose-escalation study to assess the safety and tolerability of single and repeat, inhaled doses of PC786 in healthy subjects combined with a randomised, single-blind, placebo-controlled, parallel group to assess the safety and tolerability of a single dose of inhaled PC786 in subjects with mild asthma (HMR code: 16-008)
IRAS ID
209163
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Pulmocide Ltd
Eudract number
2016-000934-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
PC786 (the study medicine) is an experimental new medicine for treating infections with a virus called Respiratory Syncytial Virus (RSV). In some people, like babies and the elderly, RSV can cause a serious illness, such as pneumonia. We hope that the study medicine will work by blocking a substance that the virus uses to multiply itself, and that it will work more effectively and against more types of RSV than existing treatments. We also hope that it will have fewer side effects than existing treatments. \n\nWe aim to find out the side effects, blood levels and levels in the nose after the study medicine is inhaled. We’ll test the study medicine in 38 people, aged 18 to 65, in 4 groups, as follows:\n\n* In Group 1, we’ll give 8 healthy volunteers 4 single doses of the study medicine. It’s never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. Participants will take up to 12 weeks to finish the study. They’ll make 6 outpatient visits, and stay on the ward for 8 nights in total.\n\n* In Groups 2 and 3, we’ll give 18 healthy volunteers twice daily doses of the study medicine for 7 days. Participants will take up to 7 weeks to finish the study. They’ll make 4 outpatient visits, and stay on the ward for 8 nights in a row.\n\n* In Group 4, we’ll give 12 people with mild asthma a single dose of the study medicine. Participants will take up to 6 weeks to finish the study. They’ll make 3 outpatient visits, and stay on the ward for 2 nights in a row.\n\nA pharmaceutical company (Pulmocide Ltd) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
London - Harrow Research Ethics Committee
REC reference
17/LO/0715
Date of REC Opinion
8 Jun 2017
REC opinion
Further Information Favourable Opinion