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NCT05830071 · ClinicalTrials.gov registry record · Phase 1
A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)
A Phase 1 study, sponsored by Chiesi Farmaceutici S.p.A..
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT05830071: Completed Phase 1 study, sponsored by Chiesi Farmaceutici S.p.A..
NCT05830071 is a Phase 1 study that has completed, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05830071, a Phase 1 study, has completed, sponsored by Chiesi Farmaceutici S.p.A..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study 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.
Primary Outcome
Placebo-adjusted change in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing CHF5993 pMDI (200/12/25 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Interventions
- DRUG Moxifloxacin 400mg
- DRUG CHF5993
- DRUG CHF5259
- DRUG CHF5993 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2023-03-29 |
| Est. Completion | 2023-10-13 |
| Phase | Phase 1 |
What the finished NCT05830071 record still lists
NCT05830071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 4 interventions - of which Moxifloxacin 400mg is the first listed.
NCT05830071 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05830071 about?
NCT05830071 is a clinical study titled "A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)". 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...
What is the current status of trial NCT05830071?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2023-03-29. Estimated completion is 2023-10-13.
What interventions are being tested in trial NCT05830071?
The interventions under investigation include: Moxifloxacin 400mg (DRUG), CHF5993 (DRUG), CHF5259 (DRUG), CHF5993 Placebo (DRUG).
Who is sponsoring clinical trial NCT05830071?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05830071's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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