PF-Atlas › Clinical Trials › NCT06746064
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF10073 After Single and Multiple Doses in Healthy Volunteers and the Effect of Itraconazole on CHF10073 Exposure
CHF10073 · Phase 1
Registry ID
NCT06746064
Phase
Phase 1
Status
Completed
Drug / intervention
CHF10073 (Part 1 - SAD)
Sponsor
Chiesi Farmaceutici S.p.A.
Start
2025-01-13
Enrollment
155
Locations
1
About this trial
The objective of this study is to assess the safety and tolerability of single ascending doses of inhaled CHF10073 (Part 1 of the study) and multiple ascending doses of CHF10073 (Part 2 of the study). The study will also evaluate the PK profile of study drug in plasma and urine after single and repeated administrations of CHF10073. In addition, this study will also investigate the metabolites profile of CHF10073 in plasma, urine and faeces (Part 2 of the study) and the PK profile of CHF10073 in the lungs after bronchoalveolar lavage (BAL) (Part 3 of the study). In addition, the effect of multiple doses of itraconazole on the pharmacokinetic profile of CHF10073 will be investigated (Part 4 of the study).
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Medical disclaimer. This page summarizes public trial data for NCT06746064 for information only. It is not medical advice, an endorsement, or an offer to enroll. Confirm details on ClinicalTrials.gov and with a qualified physician.