A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects (CHF6333 FIH)

Chiesi

Status and phase: Completed; Phase 1

Conditions: Non-Cystic Fibrosis Bronchiectasis; Cystic Fibrosis

Treatments: Drug: CHF6333 (Part 1 - SAD); Drug: CHF6333 (Part 2 - MAD); Drug: Placebo (Part 2 - MAD); Drug: Placebo (Part 1 - SAD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03056326

2015-005552-94 (EudraCT Number)

CCD-06333AA1-01

Details and patient eligibility

About

Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in healthy male subjects.

The study will comprise two parts:

Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.

Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333

Enrollment: 72 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male subjects aged 18-55 years
• BMI between 18-30 kg/m2
• Non smokers
• Lung function above 80% of predicted normal value
• Healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing

Exclusion criteria

• Any clinically relevant abnormalities and/or uncontrolled diseases
• Abnormal laboratory values
• Recent respiratory tract infection
• Hypersensitivity to the drug or excipients
• Positive serology results
• Positive cotinine, alcohol, drug of abuse tests
• Unsuitable veins for repeated venepuncture

Trial design

72 participants in 2 patient groups, including a placebo group

CHF6333 Active

Experimental group

Treatment:

Drug: CHF6333 (Part 1 - SAD)

Drug: CHF6333 (Part 2 - MAD)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo (Part 2 - MAD)

Drug: Placebo (Part 1 - SAD)