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

NCT ID: NCT06746064

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2026-01-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

CHF10073 active

Group Type: EXPERIMENTAL

CHF10073 (Part 1 - SAD)

Intervention Type: DRUG

Single doses of CHF10073 for each cohort

CHF10073 (Part 2 - MAD)

Intervention Type: DRUG

Multiple doses of CHF10073 for each cohort

CHF10073 (Part 3)

Intervention Type: DRUG

Single dose of CHF10073

CHF10073 (Part 4)

Intervention Type: DRUG

Single dose of CHF10073 in Treatment Period 1 and 2

placebo

Group Type: PLACEBO_COMPARATOR

Placebo (Part 1 - SAD)

Intervention Type: DRUG

Single doses of placebo matching CHF10073 for each cohort

Placebo (Part 2 - MAD)

Intervention Type: DRUG

Multiple doses of placebo matching CHF10073 for each cohort

CHF10073 + itraconazole

Group Type: EXPERIMENTAL

itraconazole (Part 4)

Intervention Type: DRUG

Multiple dose of itraconazole in treatment period 2

CHF10073 (Part 4)

Intervention Type: DRUG

Single dose of CHF10073 in Treatment Period 1 and 2

Interventions

CHF10073 (Part 1 - SAD)

Single doses of CHF10073 for each cohort

Intervention Type: DRUG

Placebo (Part 1 - SAD)

Single doses of placebo matching CHF10073 for each cohort

Intervention Type: DRUG

CHF10073 (Part 2 - MAD)

Multiple doses of CHF10073 for each cohort

Intervention Type: DRUG

CHF10073 (Part 3)

Single dose of CHF10073

Intervention Type: DRUG

Placebo (Part 2 - MAD)

Multiple doses of placebo matching CHF10073 for each cohort

Intervention Type: DRUG

itraconazole (Part 4)

Multiple dose of itraconazole in treatment period 2

Intervention Type: DRUG

CHF10073 (Part 4)

Single dose of CHF10073 in Treatment Period 1 and 2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject's written informed consent;
• Healthy male (Part 1 to 4) or female (Part 4) 18-55 years;
• Understanding of the study procedures and the correct use of the inhalers;
• BMI between 18.5 and 30.0 kg/m2;
• Non- or ex-smokers (<5 pack-years and stopped smoking >1 year prior to screening);
• Good physical and mental status;
• Vital signs within normal limits; body temperature <37.5°C;
• 12-lead digitised ECG in triplicate considered as normal;
• Lung function measurements within normal limits;
• Males with pregnant or non-pregnant women of childbearing potential (WOCBP) partners must be willing to use contraception
• Part 4 only: women of non-childbearing potential (WONCBP) or WOCBP with fertile male parters willing to use contraception

Exclusion Criteria

• Recent participation in another clinical trial;
• Clinically significant abnormal 24h Holter ECG (Part 1 and 2);
• Clinically relevant and uncontrolled medical disorders ;
• Subjects with history of respiratory diseases ;
• Presence of any current or recent infection;
• Clinically relevant abnormal laboratory values;
• Abnormal liver enzymes;
• Positive results from the Hepatitis serology results;
• Positive HIV-1 or HIV-2 serology results ;
• Recent blood donation or blood loss (≥450 mL) ;
• Heavy caffeine drinker ;
• Recent use of any kind of electronic smoking devices;
• Documented history of alcohol abuse within 12 months prior to screening ;
• Documented history of drug abuse within 12 months prior to screening ;
• Intake of non-permitted concomitant medications ;
• Known intolerance and/or hypersensitivity to any of the study excipients ;
• Unsuitable veins for repeated venipuncture;
• Part 3 only: contraindication to the BAL procedure;
• Part 3 only: recent lower respiratory tract infections
• Part 4 only: known allergy to antifungal medicines;
• Part 4 and females only: pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jelle Klein, MD

Role: PRINCIPAL_INVESTIGATOR

SGS Belgium

Locations

SGS Belgium NV Clinical Pharmacology Unit

Edegem, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Chiesi Clinical Trial Info

Role: CONTACT

clinicaltrials_info@chiesi.com

+39 0521 2791

Other Identifiers

2024-515442-17-00

Identifier Type: CTIS

Identifier Source: secondary_id

CLI-010073AA1-01

Identifier Type: -

Identifier Source: org_study_id