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

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Multiple Ascending Dose (MAD); Drug: Single Ascending Dose (SAD)

• Registration Number: NCT02386761
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-22
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Ascending Dose (MAD)	Multiple Ascending Dose (MAD)	* 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.
Single Ascending Dose (SAD)	Single Ascending Dose (SAD)	* 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	0-14 days

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, UK, United Kingdom