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

NCT07163182 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-09-23

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

CHF6467 Part 1 (SAD)

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

BIOLOGICAL

CHF6467 Part 2 (MAD)

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Maya Dabcheva, MD · MC Comac Medical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-08-11
Completion
2026-08-11

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Drugs

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 NCT07163182 on ClinicalTrials.gov