A Phase 1 Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers

This study consists of Part 1 followed Part 2.

Part 1 (Dose escalation study, SA001 60mg~300mg dose group) The part 1 is a dose escalation study. The starting dose is SA001 60mg, and the maximum dose is 300mg. Each dose group is assigned to SA001 or Placebo in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a single oral administration on the fasting state.

Part 2 (Single dose and food effect study, SA001 120mg and 300mg dose group) The purpose of this part 2 is to evaluate the food effect of a high-fat diets(HFDs) on the single oral dose pharmacokinetics of SA001 and its metabolite.

Inclusion criteria

• 19 years to 45 years (Healthy male Korean)
• Body weight of 55 to 90kg; and BMI of 18.0 to 27.0 kg/m^2
• Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study

Exclusion criteria

• Subject with a disease history of any clinically significant condition as below.

• Liver, Kidney, nervous system, immune system, respiratory system, endocrine system, tumor, cardiovascular disease or mental illness (mood disorder or obsessive-compulsive disorder etc.) etc.
• Subject with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the study drug
• Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)
• Serum ALT(SGPT)/AST(SGOT) >1.5×institutional upper limit normal (ULN)
• eGFR< 90mL/min/1.73m^2
• Systolic blood pressure <100 mmHg or >160 mmHg
• Diastolic blood pressure <60 mmHg or >100 mmHg
• Inadequate cardiac function confirmed by 12-lead ECG findings at screening as followings:

• QTcF > 430msec (males)
• PR interval > 200msec or < 110msec
• QRS complex > 120msec
• Evidence of 2nd- or 3rd-degree atrioventricular (AV) block
• Pathologic Q waves (defined as Q-wave > 40msec or depth > 0.5mV)
• Evidence of ventricular preexicitation, left bundle branch block (LBBB), right bundle branch block (RBBB, Incomplete RBBB)
• Subject with risk factors for Torsade de pointes such as long QT syndrome, family history of sudden death, heart failure, hypokalemia, and arrhythmias
• Subject with a history of drug abuse within 60 days prior to screening or who is positive for drugs of abuse in urine tests at screening
• Subject who received any prescription drug or herbal medicine within 14 days prior to the first administration of the Investigational product
• Subject who received any drugs such as

• Prescription drug or herbal medicine within 14 days prior to the first administration of the investigational products
• Over the counter (OTC) or vitamin within 7 days prior to the first administration of the investigational products
• Subject who received other investigational products within 90 days prior to the first administration of the investigational products
• Subject who continuously drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol during the study period
• Subject with history of smoking within 90 days prior to the first administration of the investigational products
• Subject who cannot prohibit grapefruit/ caffeine-containing foods during the study period from 3 days before the first administration of the investigational products
• Man of reproductive potential not willing to use contraceptive measures during the study period
• Subject not eligible for study participation in the opinion of the investigator