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
Overview
- Phase
- Phase 1
- Intervention
- Single Ascending Dose (SAD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Status
- Completed
- Last Updated
- 5 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Single Ascending Dose (SAD)
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.
Intervention: Multiple Ascending Dose (MAD)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 0-14 days