Safety & Tolerability of PC945 in healthy & subjects with mild asthma
Research type
Research Study
Full title
A randomised, single-blind, placebo-controlled, study to assess the safety and tolerability of single escalating and repeat, inhaled doses of PC945 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 PC945 in subjects with mild asthma.
IRAS ID
197504
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Pulmocide Ltd
Eudract number
2015-003327-64
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 25 days
Research summary
The new medicine tested in this study is called PC945. The Sponsor is developing the study medicine for treating long term (chronic) infections in the lungs caused by fungi, particularly those caused by aspergillus, a particular type of fungus. This type of infection is called aspergillosis and it can leave patients with widespread lung damage that cannot be cured.\nThe main purpose of the study is to find out if the study medicine has any important side effects in both healthy participants and participants with mild asthma. The study also investigates how much of the study medicine gets into the bloodstream when given at different doses, how quickly the body gets rids of it and whether it has an effect on breathing or any naturally occurring fungi that lives in your airway.\nVital signs, safety electrocardiogram (ECG) measurements, safety laboratory assessments, lung function tests, pharyngeal (throat swabs) and sublingual (fluid from the mouth) sample collection, physical examinations, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic (PK) analysis will be collected.\n
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0027
Date of REC Opinion
16 Mar 2016
REC opinion
Further Information Favourable Opinion