Actively Recruiting
Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and Removed in Healthy Subjects
Led by Chiesi Farmaceutici S.p.A. · Updated on 2025-09-23
68
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and Removed in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before any study procedures
- Willing and able to understand risks and comply with study procedures
- Healthy males and females aged 18 to 55 years at screening
- Weight between 50 kg and less than 85 kg with BMI between 18.0 and 30.0 kg/m2 at screening and Day -1
- Non-smoker or ex-smoker with less than 5 pack years smoking history and stopped smoking at least 1 year prior to screening
- In good physical and mental health as determined by medical history and clinical exam
- Vital signs within normal limits at screening and Day -1: diastolic blood pressure 60-89 mmHg, systolic blood pressure 90-139 mmHg, axillary body temperature 35.5-37.0°C
- Normal bedside 12-lead ECG at screening and Day -1 with heart rate 45-100 bpm and QTcF ≤450 ms (males) or ≤470 ms (females)
- Males must either use condoms if partner is a woman of childbearing potential or be non-fertile or have partner not of childbearing potential
- Females must be non-childbearing potential or use highly effective contraception if of childbearing potential
You will not qualify if you...
- Use of non-permitted medications before or during the study
- Participation in another investigational drug study within 30 days (60 days for biologics) before screening
- Significant nasal congestion, damage, bleeding, or abnormalities at screening or Day -1
- History of frequent nosebleeds
- Any acute or chronic nasal conditions that could interfere with drug administration or absorption
- Abnormal 24-hour Holter monitor findings at screening
- Uncontrolled or significant respiratory, cardiac, liver, kidney, endocrine, metabolic, neurologic, psychiatric disorders, malignancies, or conditions posing risk
- Clinically relevant abnormal laboratory values indicating undiagnosed conditions requiring further investigation
- Pregnant or lactating females confirmed by pregnancy tests at screening and Day -1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bulgaria MC Comac Medical Ltd.
Sofia, Bulgaria, 1618
Actively Recruiting
Research Team
C
Chiesi Clinical Trial Info
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here