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

A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF10073 After Single and Multiple Ascending Doses in Healthy Volunteers Via Inhalation and the Effect of Multiple Doses of Itraconazole on CHF10073 Exposure

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	CHF10073 (Part 1 - SAD)	Single doses of CHF10073 for each cohort
DRUG	Placebo (Part 1 - SAD)	Single doses of placebo matching CHF10073 for each cohort
DRUG	CHF10073 (Part 2 - MAD)	Multiple doses of CHF10073 for each cohort
DRUG	CHF10073 (Part 3)	Single dose of CHF10073
DRUG	Placebo (Part 2 - MAD)	Multiple doses of placebo matching CHF10073 for each cohort
DRUG	itraconazole (Part 4)	Multiple dose of itraconazole in treatment period 2
DRUG	CHF10073 (Part 4)	Single dose of CHF10073 in Treatment Period 1 and 2

Timeline

• Start date: 2025-01-13
• Primary completion: 2026-02-04
• Completion: 2026-02-04
• First posted: 2024-12-24
• Last updated: 2026-02-12

Locations

1 site across 1 country: Belgium