NCT03378648View on ClinicalTrials.gov

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366

PHASE1/PHASE2CompletedINTERVENTIONAL

Enrollment

118

Participants

Timeline

Start Date

December 28, 2017

Primary Completion Date

April 16, 2019

Study Completion Date

April 16, 2019

Conditions

AsthmaChronic Obstructive Pulmonary Disease

Interventions

DRUG

CHF6366

"Drug: CHF6366 (Part 1 - SAD) Single doses of CHF6366 at each period (for up to 3 periods per subject)~Drug: CHF6366 (Part 2 - MAD) Once daily doses of CHF6366 for 7 days~Drug: CHF6366 (Part 3) Single dose of CHF6366"

DRUG

Placebo CHF6366

"Drug: Placebo (Part 1 - SAD) Single doses of placebo matching CHF6366 at each period (for up to 3 periods per subjects)~Drug: Placebo (Part 2 - MAD) Once daily dose of placebo matching CHF6366 for 7 days~Drug: Placebo (Part 3) Single dose of placebo matching CHF6366"

DRUG

umeclidinium bromide and vilanterol trifenatate

Part 3 Single dose

Trial Locations (1)

Unknown

Medicines Evaluation Unit, Manchester

All Listed Sponsors

lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

NCT03378648 - A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366 | Biotech Hunter | Biotech Hunter