A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001 (CHF6001Ext)

Chiesi

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Multiple Ascending Dose (MAD); Drug: Single Ascending Dose (SAD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02386761

CCD-06001AA1-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

Single Ascending Dose (SAD)

Experimental group

Description:

* 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.

Treatment:

Drug: Single Ascending Dose (SAD)

Multiple Ascending Dose (MAD)

Experimental group

Description:

* 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.

Treatment:

Drug: Multiple Ascending Dose (MAD)