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.
To assess the safety and tolerability of single and repeated ascending doses of CHF 6001 in healthy volunteers and to investigate the pharmacokinetic (PK) profile of CHF 6001 and its metabolites CHF 5956 and CHF 6095.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Main Inclusion
Subject's written informed consent obtained prior to any study-related procedure
Male and female Caucasian healthy volunteers aged 18-55 years inclusive
Vital signs:Subjects aged 18-45: Diastolic BP 40-90, Systolic BP 90-140 Subjects aged 45-55: Diastolic BP 40-90, Systolic BP 90-150 (as mean of three measures performed after at least 5 minutes of resting); checked at screening visit and Day -1
12-lead digitised Electrocardiogram (12-lead ECG) considered as normal (40≤Heart rate≤110bpm,120 ms ≤ PR ≤ 210 ms, QRS ≤ 120 ms, QTcF ≤ 450 ms for males and ≤ 470ms for females) checked at screening visit and Day -1
Lung function measurements within normal limits: FEV1 \> 80% of predicted normal value (according to the Global Lung Function Initiative, ERS Task Force Lung Function Reference Values (1,2) ) and FEV1/FVC ratio \> 0.70
Main Exclusion:
Pregnant or lactating women
Clinically significant cardiac abnormalities
Any clinically relevant abnormal laboratory values
Clareo Health | A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001
