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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase 1, 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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Single Ascending Dose (SAD)
* Drug: Multiple Ascending Dose (MAD)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Ascending Dose (SAD)<br>Dose 1 (SAD1): 6 inhalations of CHF 6001 400 µg giving a total dose of 2400 µg Dose 2 (SAD2): 10 inhalations of CHF 6001 400 µg giving a total dose of 4000 µg Dose 3 (SAD3): 12 inhalations of CHF 6001 400 µg giving a total dose of 4800 µg Placebo (P): the number of placebo inhalations will match that of the active CHF 6001 pertaining to the same dose period. In case the actual doses are modified, the number of inhalations will be adapted accordingly. | Drug: Single Ascending Dose (SAD)<br> <br> * Other names: CHF6001;|
| Experimental: Multiple Ascending Dose (MAD)<br>Dose 1 (MAD1): Multiple doses of CHF 6001 - Total daily dose 2400 µg or placebo Dose 2 (MAD2): Multiple doses of CHF 6001 - Total daily dose 4000 µg or placebo Dose 3 (MAD3): Multiple doses of CHF 6001 - Total daily dose 4800 µg or placebo Duration 14 days b.i.d. | Drug: Multiple Ascending Dose (MAD)<br> <br> * Other names: CHF6001;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 0-14 days |