Micro: A Phase 0 Experimental Medicine Study of ADS032 v1
Research type
Research Study
Full title
Micro: A Phase 0 Experimental Medicine Study to Provide Early Mechanistic Data in Humans of NLRP3/1 Inflammasome Inhibition after direct intrapulmonary dosing of ADS032.
IRAS ID
318427
Contact name
Nik Hirani
Contact email
Sponsor organisation
Accord
ISRCTN Number
ISRCTN35867933
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 9 months, 10 days
Research summary
Laboratory and animal models are used by scientists to understand the progress of a disease and to identify new potential treatments. Generally, once a new candidate has been shown to work in these pre-clinical models, first-in-human Phase I clinical trials follow. Despite a great deal of assessment, a large number of these candidates fail at this stage which is incredibly costly, especially for the patient. \n\nPhase 0 studies are carried out between pre-clinical and phase I stages and have the potential to improve pre-clinical candidate selection by providing human in vivo data earlier in the development process. Phase 0 studies test new candidate drugs at very low levels (100 μg or less) for the first time in human patients and have the potential to deliver very important information for that new candidate. \nSarcoidosis is a form of interstitial lung disease (ILD) and is characterised by non-necrotising granuloma formation, inflammation and fibrosis. Lung disease is manifest in >90% of patients and an increased immune activity is seen in those with ILD. Current treatment of is mainly long term corticosteroids with additional immunosupressants which have a number of associated side-effects. Drugs or therapies directly targeting the cells involved in the lung is lacking.\n\nThis study seeks to test the hypotheses that a new Clinical Investigational Agent (CIA), ADS032 could prevent disease causing immune activity. Patients will be suspected or confirmed as having ILD or bronchiectasis and may be undergoing a surgical process to remove part of their lung. Up to 18 patients would receive a low dose of ADS032 directly into the lung during a bronchoscopy procedure in hospital to investigate how the CIA is absorbed and metabolised and if it does reduce immune activity where the disease occurs. Patients will be monitored and samples taken in the 24h after the procedure. \n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0077
Date of REC Opinion
27 Apr 2023
REC opinion
Further Information Favourable Opinion