RecruitingPhase 1NCT07163182

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

A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF6467 After Single and Repeated Ascending Doses by Intranasal Route in Healthy Adult Subjects


Sponsor

Chiesi Farmaceutici S.p.A.

Enrollment

68 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CHF6467 Part 1 (SAD), a biological treatment called CHF6467 Part 2 (MAD), and others for people with healthy volunteers. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCHF6467 Part 1 (SAD)

Intranasal administration of single ascending doses of CHF6467 in 4 different cohorts

BIOLOGICALCHF6467 Part 2 (MAD)

Intranasal administration of multiple ascending doses of CHF6467 in 3 different cohorts

DRUGPlacebo

Intranasal administration of matched-placebo of CHF6467 in Part 1 and Part 2


Locations(1)

Bulgaria MC Comac Medical Ltd.

Sofia, Bulgaria

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NCT07163182


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