A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of CHF6297 in Healthy Subjects and Patients With COPD
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Part 1, Part 2, Part 4 (Healthy subjects):
Male subjects aged 18-55 years;
Non smokers
Lung function above 80% of predicted normal value
Healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing
ability to produce an adequate induced sputum sample (study part 4 only)
Part 3 (COPD patients):
Males and females aged 40-75 years
Current or past smokers
stable patients with a post-bronchodilator FEV1 between 40 and 80% of predicted normal value and FEV1/FVC ratio \<0.7
Ability to produce a spontaneous and an adequate induced sputum sample
You may not be if
Parts 1,2, 4 (Healthy subjects):
Any clinically relevant abnormalities and/or uncontrolled diseases
Abnormal laboratory values
Recent respiratory tract infection
Hypersensitivity to the drug or excipients
Positive serology results
Positive cotinine, alcohol, drug of abuse tests
Part 3 (COPD patients):
Females of childbearing potential
History of asthma
Unstable concomitant diseases
Abnormal relevant Holter ECG parameters
Recent acute exacerbations of COPD or respiratory tract infection
Hypersensitivity to the drug or excipients
Positive serology results
Clareo Health | A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of CHF6297 in Healthy Subjects and Patients With COPD
