Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and Removed in Healthy Subjects
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: 1. Subject's written informed consent obtained prior to any study-related procedures; 2. Willingness and ability to understand the risks involved and to understand and comply with the study procedures; 3. Healthy male and female subjects, aged 18-55 years inclusive at screening; 4. 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; 5. Non-smoker or ex-smoker who smoked less than 5 pack years (Pack years = the number of cigarette packs per day times the number of years) and stopped smoking at least 1 year prior to screening; 6. Good physical condition and mental status determined by the Investigator, based on the subject's medical history and general clinical examination at screening and Day -1; 7. Vital signs within normal limits at screening and at Day-1: 60 mmHg ≤ diastolic blood pressure (DBP) ≤ 89 mmHg, 90 mmHg ≤ systolic blood pressure (SBP) ≤ 139 mmHg (three measures performed after at least 5