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

Chiesi

Status and phase: Enrolling; Phase 1

Conditions: Pulmonary Fibrosis

Treatments: Drug: CHF10073 (Part 2 - MAD); Drug: CHF10073 (Part 3); Drug: itraconazole (Part 4); Drug: CHF10073 (Part 1 - SAD); Drug: Placebo (Part 2 - MAD); Drug: CHF10073 (Part 4); Drug: Placebo (Part 1 - SAD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06746064

2024-515442-17-00 (EU Trial (CTIS) Number)

CLI-010073AA1-01

Details and patient eligibility

About

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).

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 3 patient groups, including a placebo group

CHF10073 active

Experimental group

Treatment:

Drug: CHF10073 (Part 4)

Drug: CHF10073 (Part 1 - SAD)

Drug: CHF10073 (Part 3)

Drug: CHF10073 (Part 2 - MAD)

placebo

Placebo Comparator group

Treatment:

Drug: Placebo (Part 1 - SAD)

Drug: Placebo (Part 2 - MAD)

CHF10073 + itraconazole

Experimental group

Treatment:

Drug: CHF10073 (Part 4)

Drug: itraconazole (Part 4)