ETD002 - first doses in humans
Research type
Research Study
Full title
A first in human randomised, double blind, placebo-controlled, three-part study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses (SAD & MAD) of inhaled ETD002 in healthy male and female subjects (HMR code: 20-004)
IRAS ID
283419
Contact name
Kathy Woodward
Contact email
Sponsor organisation
Enterprise Therapeutics Ltd,
Eudract number
2020-001080-92
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine is an experimental medicine for treating cystic fibrosis, an inherited condition that causes sticky mucus to build up in the lungs and digestive system.
There's no cure for cystic fibrosis. Current treatments help control the symptoms, but they don’t work for everyone, and some treatments are burdensome. We hope the study medicine will be more effective than existing treatments at thinning the sticky mucus that builds up in the lungs of cystic fibrosis patients. We also hope it will stay in the lungs longer than existing treatments, so that patients won’t have to take it as often.
This is a 2-part study (Part A and Part B) in healthy volunteers, aged 18–50 years. We aim to find out any side effects and measure blood levels of the study medicine, when inhaled as single and repeated doses. The study medicine has never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses.
In Part A, we’ll give single doses of the study medicine to up to 8 groups of 8 participants (up to 64 healthy volunteers). Participants will take up to 6 weeks to finish the study. They’ll make up to 4 outpatient visits and stay on the ward for 3 nights in a row.
In Part B, we’ll test repeated doses of the study medicine in up to 3 groups of 8 participants (up to 24 healthy volunteers). Participants will take the study medicine for 7–14 days. They’ll take up to 9 weeks to finish the study. They’ll make 2 outpatient visits, and stay on the ward for up to 15 nights in a row.
A pharmaceutical company (Enterprise Therapeutics Ltd) is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
20/NI/0060
Date of REC Opinion
29 May 2020
REC opinion
Favourable Opinion