A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HSG4112 in High Doses

Exclusion Criteria

• •1. Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular disease, or psychiatric disorder (e.g., mood disorder, obsessive-compulsive disorder).
• •2. History of stomach or intestinal disorders (e.g., Chrons disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the pharmacokinetic or pharmacodynamic evaluation of the investigational product.
• •3. Significant history or clinical manifestation of hypersensitivity to any drug compound (e.g., licorice-containing drugs, aspirin, antibiotics).
• •4. One or more of the following laboratory test results at screening:
• •* ALT (SGPT) \> 60 IU/L
• •* Glucose (fasting) \> 110 mg/dL or \< 70 mg/dL
• •5. Systolic blood pressure of \< 90 mmHg or \> 150 mmHg, or diastolic blood pressure of \< 60 mmHg or \> 100 mmHg as determined by vital signs monitored after resting in sitting position for at least 3 minutes.
• •6. History of drug/chemical abuse or tested positive in urine drug screen.
• •7. Use or intend to use any prescription medications/products or phytotherapeutic/herbal/plant-derived preparations within 14 days prior to dosing, or any nonprescription medications/products (i.e., over-the-counter (OTC) drugs), health products, or vitamins within 7 days prior to dosing, unless deemed acceptable by the Investigator.
• •8. Participation in any clinical study or bioequivalence study involving the administration of an investigational drug, including any study investigating HSG4112, within 6 months prior to dosing (i.e., within 6 months of the last dose from the previous study).
• •9. Whole blood donation within 2 months prior to dosing, plasma/platelet donation within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing.
• •10. Smoker. However, participation is acceptable if the subject has quit smoking at least 90 days prior to dosing.
• •11. Alcohol consumption of \> 21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period, starting from 3 days prior to dosing.
• •12. Ingestion of grapefruit-containing foods or beverages 24 hours prior to dosing until discharge, or unable to abstain from ingesting such foods or beverages during the same period.
• •13. Unable to abstain from caffeine-containing foods or beverages (e.g., coffee, tea (e.g., black tea, green tea), soft drinks, coffee milk, energy drinks, sports drinks) during the admission period.
• •14. Unable or unwilling to use acceptable contraceptive methods for themselves or their spouse/partner during the entire study period and up to 28 days after the last dosing and subjects who satisfy at least one of the pregnancy-related criteria below:
• •* females of childbearing potential who plan to use hormonal contraceptives or oral contraceptives during the study period
• •* females of childbearing potential confirmed "positive" in a pregnancy test
• •* "females of childbearing potential" refer to females who have experienced menarche and have not undergone a successful surgical sterilization procedure (i.e., hysterectomy, bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy) or is not menopause (i.e., 12 months without menstruation).
• •* Acceptable contraceptive methods include:
• •1. Use of an intrauterine device, which has been proven highly effective.
• •2. Physical contraception for subject or spouse/partner used with chemical sterilization (e.g., spermicide).
• •3. Surgical sterilization (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy).
• •15. Subjects who, in the opinion of the Investigator, should not participate in this study based on clinical laboratory test results or other reasons.