SAD and MAD Study of FTX-101 in Healthy Male Subjects

Eligibility Criteria

• * Willingness to comply with all study procedures and availability for the duration of the study
• * Healthy adult male
• * Aged at least 18 years but not older than 59 years
• * Body mass index (BMI) within 18.5 kg/m\^2 to 32.0 kg/m\^2, inclusively
• * Non- or ex-smoker
• * Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG.
• * Supine or semi-supine pulse rate less than 45 beats per minute (bpm) or more than 100 bpm
• * Supine or semi-supine blood pressure below 90/50 mmHg
• * Supine or semi-supine blood pressure higher than 150/95 mmHg
• * History of significant hypersensitivity to FTX-101 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• * Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
• * History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
• * Showing suicidal tendency from 6 months prior to screening
• * Presence of out-of-range cardiac intervals at screening defined as:
• * PR \< 110 msec, PR \> 200 msec
• * QRS \< 60 msec, QRS \>110 msec)
• * QT Interval Corrected for Heart Rate using Fridericia's Correction Formula (QTcF): • \> 450 msec
• * History of additional risk factors for torsade's de pointes
• * Use of concomitant medications that prolong the QT/ corrected QT (QTc) interval
• * Current use (in the last 6 months) of alcohol (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
• * Any history of substance or alcohol use disorder within the past 2 years and/or current maintenance therapy (within the past 2 years) for treatment of substance use disorder
• * Use of any prescription drugs in the 28 days or 5 half-lives, whichever is longer, prior to the first study treatment administration, that in the opinion of an investigator would put into question the status of the participant as healthy
• * Use of St. John's wort in the 28 days prior to the first study treatment administration
• * Positive screening results to HIV Ag/Ab combo, hepatitis B surface Ag or hepatitis C virus tests
• * Intake of an investigational product (IP) in the 28 days prior to the first study treatment administration or within 5 times the elimination half-life of the IP, whichever is longer
• * Donation of plasma in the 7 days prior to the first study treatment administration
• * Donation of 1 unit of blood to American Red Cross or equivalent organization or donation of over 500 mL of blood in the 56 days prior to the first study treatment administration