INFEX-PROTECT 1
Research type
Research Study
Full title
A Phase I, Double-Blind, Placebo-Controlled, Ascending Single Intravenous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Participants and Non-Cystic Fibrosis Bronchiectasis Patients colonized with Pseudomonas aeruginosa administered INFEX702
IRAS ID
1004503
Contact name
Derek Lindsey
Contact email
Sponsor organisation
Infex Therapeutics
Eudract number
2021-005018-32
ISRCTN Number
ISRCTN17978477
Research summary
We need to find better treatments for people who have lung damage that puts them at higher risk of lung infection, such as a condition called Non-Cystic Fibrosis Bronchiectasis (NCFB). People with NCFB are at risk of catching a bug (bacteria) called Pseudomonas (Pa). Infection with this bug can last a long time, cause repeated infections (called exacerbations) and further damage the lungs. This really affects the quality of life for people with NCFB and also puts them at risk of major health events such as ending up in hospital and even death. People with NCFB can have 8-12 infections a year. At the moment, we don't fully understand what things make NCFB happen. Having repeated lung infections can play a role.
This study aims to test a new medicine for the prevention of infections in people who have NCFB and also have the bug Pa present in their lungs. We will start by testing the drug in healthy people who have normal lungs to confirm a safe dose. Once we know what dose is safe in healthy people we will then check it is also safe in people with NCFB.
Each person that takes part in the study will stay on the unit for 4-5 days and will be looked after very closely by the doctors and nurses. They will receive one dose of the study drug as a drip through a vein. They will return for 9 further outpatient visits. Depending on the safety signals and what levels of the drug we find in the blood tests, we may need to add in additional visits (no more than 3). The current planned length of the study is 106 days until final follow-up.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0048
Date of REC Opinion
25 Mar 2022
REC opinion
Further Information Favourable Opinion