NCT06166056

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Doses in Healthy Volunteers and After Single and Repeated Doses in Subjects With Bronchiectasis

A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Ascending Doses in Healthy Volunteers and One Single Dose in Adult Subjects With Bronchiectasis, Followed by a Placebo-controlled, Repeated Dose, 3-way Cross-over in Adult Subjects With Bronchiectasis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The aim of this clinical trial is to assess the safety of: * single doses of the study drug CHF6333 in Healthy Volunteers (HVs) and in subjects with Bronchiectasis (BE) - Part I * repeated doses of the study drug CHF6333 in subjects with BE - Part II

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	CHF6333	CHF6333 Part I SAD; CHF6333 Part II MD.
DRUG	CHF6333 Placebo	Placebo Part I SAD; Placebo Part II MD.

Timeline

• Start date: 2023-11-29
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-12-12
• Last updated: 2026-03-05

Locations

9 sites across 1 country: United Kingdom