AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects.

Exclusion Criteria

• •Women of child-bearing potential
• •Life-time substance use disorders (SUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
• •Recreational use of drugs of abuse within the last month prior to study drug administration.
• •Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration.
• •Life-time history of bipolar disorders, psychosis or suicidal attempts assessed by the Dual Diagnosis Screening Instrument (DDSI).
• •History of anxiety or depression not completely recovered within 12 months prior to study drug administration, as assessed by the DDSI.
• •Lifetime history of deliberate self-harm due to suicidal ideation or suicidal ideation prior to study drug administration, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
• •Clinically relevant cognitive impairment preventing the administration of the psychometric tests
• •Any other clinically relevant disease or condition that in the judgment of the investigator might interfere with the subject's ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject's safety.
• •Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption
• •Subjects with a clinically significant disease within one month prior to study drug administration.
• •Any clinically relevant findings in physical examination, vital signs, ECG and safety laboratory parameters.
• •Positive hepatitis or HIV test.
• •Positive Covid19 PCR test within 72h before admission (Day -1) to the research facility
• •Have abnormal screening values for the steroid hormones: cortisol, testosterone, estradiol and progesterone relative to their reproductive status.
• •Known hypersensitivity to any drug (in particular steroids) or drug excipients.
• •Use of drugs known to induce or inhibit hepatic drug metabolism within one month prior to study administration or during the study and use of citrus juice during the study.
• •Any prescription or over-the-counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements and in particular any parenteral or topical product containing steroids, within 2 weeks (or more considering the elimination half-life of the product) prior to study drug administration
• •Donation of blood or plasma within one month prior to study drug administration or transfusion of blood or plasma for medical/surgical reasons or intention to donate blood or plasma within one month after study drug administration.
• •History of inadequate venous access and/or experience of difficulty donating blood.
• •Not able/not willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items when out of CRU.
• •Subject included in a clinical study within 3 months prior to study drug administration.
• •Subject already included in other parts of this study