A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of inhaled chf 6001.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Criteria

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