Investigating the safety and pharmacokinetics of inhaled CHF10073 in healthy volunteers

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

This study is testing a new inhaled medication called CHF10073 to see if it's safe and how it behaves in the bodies of healthy men aged 18-55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Male
• Sponsor: Chiesi Farmaceutici S.p.A. (Industry-sponsored)
• Locations: 1 site (Edegem)
• Trial ID: NCT06746064 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and tolerability of inhaled CHF10073 through single and multiple ascending doses in healthy male volunteers aged 18-55. It will assess the pharmacokinetics (PK) of the drug in plasma, urine, and the lungs after bronchoalveolar lavage. The study consists of three parts: single ascending doses, multiple ascending doses, and a PK profile analysis in the lungs. Participants will be monitored for vital signs and lung function to ensure they meet health criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males aged 18-55 with a BMI between 18.5 and 30.0 kg/m2 who are non-smokers or ex-smokers.

Not a fit: Patients with a history of respiratory diseases or significant medical disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of CHF10073's safety profile, paving the way for future treatments for pulmonary fibrosis.

How similar studies have performed: While this study focuses on a specific inhaled treatment, similar studies assessing the safety and pharmacokinetics of new drugs have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

* Subject's written informed consent;
* Healthy males aged 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 WOCBP partners must be 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

Where this trial is running

Edegem

• SGS Belgium NV Clinical Pharmacology Unit — Edegem, Belgium (Recruiting)

Study contacts

• Principal investigator: Frédéric Vanhoutte, MD — SGS Belgium
• Study coordinator: Chiesi Clinical Trial Info

Conditions Pulmonary Fibrosis