A Study to Compare How CHF10196 (Florensocatib) is Absorbed Into the Blood When Given Alone and With a Drug That Reduces Stomach Acid in Healthy Male Participants

An Open-label, Fixed-sequence, Non-randomised, Drug-drug Interaction Study to Evaluate the Effect of Pantoprazole (Proton Pump Inhibitor) on the Pharmacokinetics of CHF10196 in Healthy Male Participants.

This Phase 1 study evaluates the effect of pantoprazole (a proton pump inhibitor) on the pharmacokinetics (PK) of CHF10196 (Florensocatib) in healthy male participants. Participants receive CHF10196 alone and in combination with pantoprazole to assess potential drug-drug interaction (DDI) effects on systemic exposure.

Key Inclusion Criteria:

• BMI (body mass index) between 18.0 and 30.0 kg/m²
• Weight between 45 and 100 kg
• Non-smokers or ex-smokers (<5 pack-years)
• Clinically healthy based on medical history and examination
• Normal vital signs
• Normal ECG
• Willingness to comply with contraception requirements

Key Exclusion Criteria:

• Recent participation in another clinical study
• Significant medical conditions
• Abnormal laboratory values
• Positive HIV or hepatitis tests
• Recent infection or COVID-19
• Drug or alcohol abuse
• Use of prohibited medications
• Gastrointestinal surgery affecting absorption
• Hypersensitivity to study drugs