A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)

Study Identifier:

CLI-05993AB7-03

ClinicalTrials.gov Identifier:

NCT05830071

EudraCT Identifier:

N/A

Study Contact Information:

N/A

Study Complete

Study Details

Medical Condition

Asthma
Chronic Obstructive Pulmonary Disease

Study Drug

Drug: CHF5993
Drug: CHF5259
Drug: Moxifloxacin 400mg
Drug: CHF5993 Placebo

Date

Mar 2023 - Oct 2023

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 18 - 55 Years

Requirements Information

Healthy Volunteers

Yes

Protocol Summary

The purpose of this study is to evaluate the potential for cardiac repolarization, according to electrocardiographic monitoring (including QT and QTc intervals), of two dose levels of CHF5993 pMDI (beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB)) and of one dose of CHF5259 (GB) in healthy subjects compared to moxifloxacin and placebo.

Study Locations

Location

Status

Location

PAREXEL Baltimore Early Phase Clinical Unit

Baltimore, Maryland, United States, 21225

Status

N/A