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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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 5, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Apr 2026 to Aug 2026 Eligibility criteria revised · Site details revised at 2 of 9 sitesv5 Show 2 more changesShow less
    • Eligibility criteria revised
    • Site details revised at 2 of 9 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Primary and study completion dates: Jun 2025 to Apr 2026 Study sites: 8 to 9 · Eligibility criteria expanded, about 136 words · Secondary endpoints: details revised at 4 of 11 entriesv4 Show 3 more changesShow less
    • Study sites: 8 to 9
    • Eligibility criteria expanded, about 136 words
    • Secondary endpoints: details revised at 4 of 11 entries

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 2 to 8v3
  4. Study title expanded, about 24 words Eligibility criteria expanded, about 2 wordsv2 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06166056
Lead Sponsor Chiesi Farmaceutici S.p.A.
Conditions Bronchiectasis
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov