Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07163182 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and Removed in Healthy Subjects

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Aug 11, 2026 → Feb 28, 2027
See other at-risk trials from Chiesi Farmaceutici S.p.A.

Record History

  1. Primary and study completion pushed from Aug 11, 2026 to Feb 28, 2027 Primary endpoints: details revised at 1 of 18 entries · Eligibility criteria expanded, about 24 words · Secondary endpoints: details revised at 2 of 19 entries Show 3 more changesShow less
    • Primary endpoints: details revised at 1 of 18 entries
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 2 of 19 entries
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 10, 2025 to Sep 15, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Sep 10, 2025 to Sep 15, 2025
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A clinical trial to investigate the safety and tolerability of single and multiple intranasal (through the nose) dosing with the study drug CHF6467 in 68 healthy adult subjects. The study will investigate also how CHF6467 moves and behaves in the blood and in the fluid around the brain and spinal cord (cerebrospinal fluid) and if the drug CHF6467 causes an immune response by looking for specific molecules, called antibodies that may form against it. The study will be divided into two parts - Part 1 (testing single ascending doses of the study drug, SAD, lasting 4 days) and Part 2 (testing repeated or multiple ascending doses of the study drug, MAD, lasting 11 days). Each part of the study consists of a screening period, when eligible healthy volunteers will be selected, a treatment period, during which the study drug administration will take place and a follow-up period.
Trial Details
NCT Number NCT07163182
Lead Sponsor Chiesi Farmaceutici S.p.A.
Conditions Healthy Volunteers
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov