Safety, tolerability & PK of CHF 6523 in HV & COPD patients
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of CHF 6523 after single or multiple ascending doses in healthy subjects, followed by a placebo controlled repeated dose 2-way crossover in COPD subjects
IRAS ID
259145
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2018-004162-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Richmond Pharmacology are conducting a first-in-human clinical study with an experimental drug known as CHF 6523 in healthy volunteers. CHF 6523 is being developed by Chiesi Pharmaceuticals as a treatment for Chronic Obstructive Pulmonary Disease (COPD), a lung condition also known as emphysema. COPD is often caused by smoking and is a life-limiting condition that leads to hospital admissions and deaths. CHF 6523 is a dry powder for inhalation supplied in capsules delivered via an inhaler device (Plastiape RS-01), and this clinical trial will be the first time that CHF 6523 will be tested in humans. CHF 6523 has been studied in laboratory animals and shown to be safe and well tolerated.
This is a randomised, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of CHF 6523 after single or multiple ascending doses in healthy subjects. We aim to recruit at least 72 male healthy volunteers in Part 1 and Part 2. In Part 1 of the study we will recruit at least 24 male volunteers aged between 18 and 40 years inclusive, and these volunteers will attend for three in-house periods for single ascending doses of CHF 6523. In Part 2, four cohorts of 12 volunteers will attend for multiple ascending twice daily doses of CHF 6523. Part 3 will involve patients, will take place outside of the UK and will not be detailed in this submission.
The aim of the study is to assess the safety and tolerability of single ascending doses of CHF 6523 in healthy volunteers and how long CHF 6523 stays in the body of healthy volunteers after administration. Safety and tolerability will be assessed by physical examination, vital sign measurements, laboratory evaluations, lung function tests, electrocardiogram (ECG) and monitoring of adverse events (AEs). Pharmacokinetics will be evaluated using plasma and urine sampling.REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/0107
Date of REC Opinion
9 May 2019
REC opinion
Favourable Opinion