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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

NCT06166056 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-05

No results posted yet for this study

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

Interventions

DRUG

CHF6333

CHF6333 Part I SAD; CHF6333 Part II MD.

DRUG

CHF6333 Placebo

Placebo Part I SAD; Placebo Part II MD.

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • James D. Chalmers · School of Medicine, University of Dundee, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06166056 on ClinicalTrials.gov