Safety and Tolerability of CFTX-1554 in Healthy Subjects

Exclusion Criteria

• •Previous participation in the current study
• •History of relevant drug and/or food allergies
• •Allergy or hypersensitivity to active ingredient or excipients of the study drug
• •Using nicotine-containing products within 60 days prior to the first study drug administration
• •History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year before screening
• •Positive drug and alcohol screen in urine (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, nicotine metabolites \[cotinine\], and alcohol) at screening or at one of the admissions to the clinical research center
• •Average intake of \>24 units of alcohol/week
• •Positive screen for hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus 1 and 2 antibodies
• •Participation in a drug study within 30 days prior to the first study drug administration in the current study (counting from the follow-up visit to the screening visit). Participation in ≥4 other drug studies in the 12 months before the first study drug administration in the current study
• •Donation or loss of \>450 mL of blood within 60 days pribefore the first study drug administration. Donation or loss of \>1.5 L of blood in male subjects) or \>1.0 L of blood in female subjects in the 10 months before the first study drug administration in the current study.
• •Significant and/or acute illness within 5 days before the first study drug administration that may impact safety assessments, in the opinion of the Investigator.
• •Unwillingness to consume the Food and Drug Administration (FDA) breakfast or intolerance to any of the ingredients of the FDA breakfast (Cohort A5 only)
• •Vaccination against SARS-CoV-2 planned between 2 weeks before first admission and follow-up.
• •Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1, or any known contact with a person who tested positive for SARS-CoV-2 or with a COVID 19 patient within 2 weeks before admission.