Phase 1Not yet recruitingAge-related condition
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis
A Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
- Sponsor
- Chiesi Farmaceutici S.p.A. (Industry)
- Enrolment
- 18 planned
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- CHF10073 low dose; CHF10073 high dose; Placebo
- Ages
- adults, older adults
- Registry
- NCT07876284, CTIS2026-526678-18-00
Full record on ClinicalTrials.gov
From the registry
The objective of the study is to assess the safety and tolerability of repeated doses of CHF10073 and to characterise cough-related safety outcomes associated with CHF10073 administration. In addition, the study will also characterise the PK (pharmacokinetics) profile in plasma after repeated administrations of study drug.
Primary outcomes
- Number and % of participants with treatment-emergent adverse events, adverse drug reactions, serious and non-serious events, related and non-related events, severe events, events leading to discontinuation and events leading to death
- Change from baseline in systolic and diastolic blood pressure
- Change from baseline in pulse rate, respiratory rate
- Change from baseline in body temperature
History
Primary completion expected
Expected to start
Registered