NCT01703052

Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers (HV)

A Placebo-controlled Double-blind Single and Repeated Ascending Dose Study to Investigate the Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers.

Detailed description

The study will be conducted in a single centre and will consist of a single dose part and a multiple dose part. Seven single doses of CHF 6001 will be administered according to an escalation, alternate cross over scheme. Five multiple doses of CHF 6001 will be administered for 7 days according to a sequential escalation scheme.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	CHF 6001 SD or placebo	Dry Powder Inhaler
DRUG	CHF 6001 MD or placebo	Dry Powder Inhaler

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-10-10
• Last updated: 2020-07-31

Locations

1 site across 1 country: United Kingdom