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.
Subject's written informed consent obtained prior to any study-related procedures;
Willingness and ability to understand the risks involved and to understand and comply with the study procedures;
Healthy male and female subjects, aged 18-55 years inclusive at screening;
Weight ≥ 50 kg and <85 kg and Body Mass Index (BMI) between 18.0 and 30.0 kg/m² inclusive at screening and on Day -1;
The subject has taken non-permitted concomitant medications in the predefined period prior to screening or prior to randomisation or is expected to take non-permitted concomitant medications during the study;
Participation to investigational study: subjects who have received any investigational drug within the 30 days (60 days for biologics) or a more appropriate time as determined by the Investigator (e.g. approximately 5 half-lives of the investigational drug whatever is longer);
Significant nasal congestion or signs of nasal damage, bleeding, excoriation or ulceration at physical examination at screening or Day -1;
History of frequent nosebleeds;
Parallel
CHF6467 Part 1 (SAD)
Biological/VaccineIntranasal administration of single ascending doses of CHF6467 in 4 different cohorts
CHF6467 Part 2 (MAD)
Biological/VaccineIntranasal administration of multiple ascending doses of CHF6467 in 3 different cohorts
Placebo
DrugIntranasal administration of matched-placebo of CHF6467 in Part 1 and Part 2
Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Number of events and number and percentage of subjects experiencing treatment-emergent AEs (TEAEs), treatment-emergent ADRs, serious TEAEs, non-serious TEAEs, severe TEAEs, TEAEs leading to discontinuation of study treatment and TEAEs leading to death
Vital signs: heart rate (HR)
Mean absolute value
Vital signs: body temperature (BT)
Mean absolute value
Vital signs: systolic blood pressure (SBP), diastolic blood pressure (DBP)
* Mean absolute value * Mean change from baseline
CHF6467 AUC0-24h
Area under the concentration-time curve from time 0 to 24 h
CHF6467 AUC0-t
Area Under the Curve from time 0 to time t
CHF6467 AUC0-∞
Area Under the Curve from time 0 Extrapolated to Infinity
CHF6467 Cmax
Maximum Serum Concentration
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