NCT06746064View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

January 13, 2025

Primary Completion Date

January 29, 2026

Study Completion Date

January 29, 2026

Conditions
Pulmonary Fibrosis
Interventions
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

Trial Locations (1)

2650

RECRUITING

SGS Belgium NV Clinical Pharmacology Unit, Edegem

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY