Trials / Completed
CompletedNCT02386761
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Single Ascending Dose (SAD) | |
| DRUG | Multiple Ascending Dose (MAD) |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2015-05-01
- Completion
- 2015-05-01
- First posted
- 2015-03-12
- Last updated
- 2020-07-31
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02386761. Inclusion in this directory is not an endorsement.