A Safety and PK Study of EC-18 in Healthy Subjects

Exclusion Criteria

• •Febrile (temperature ≥99.5°F/37.5°C) at the Screening Visit or at admission to the research clinic on Day -1.
• •Clinically significant laboratory findings at the Screening Visit defined as the following:
• •* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin \>1.5 x upper limit of normal (ULN)
• •* Blood urea nitrogen (BUN), creatinine \>1.25 x ULN
• •* White blood cell (WBC) count \<0.9 x lower limit of normal (LLN) or \>1.1 x ULN
• •* Hemoglobin or hematocrit \<0.9 x LLN or \>1.1 x ULN
• •* Platelet count \<0.9 x LLN or \>1.1 x ULN
• •* Glucose \<0.9 x LLN or \>1.25 x ULN
• •* Thyroid-stimulating hormone (TSH) \<0.75 x LLN or \>1.25 x ULN or any other laboratory, ECG, vital sign, or physical abnormality that, in the investigator's opinion, unfavorably increases the risk of study participation.
• •Positivity for human immunodeficiency virus (HIV) or receiving active antiretroviral therapy, hepatitis B surface antigen positivity, or hepatitis C positivity.
• •History of drug or alcohol abuse within the past 2 years.
• •Females who are pregnant or intend to get pregnant over the next month.
• •Positive urine pregnancy test at the Screening Visit or at admission to the research clinic on Day -1.
• •Positive urine drug or breath alcohol test at the Screening Visit or at admission to the research clinic on Day -1. Subjects should be instructed not to drink alcohol within 12 hours of the screening assessment.
• •Intake of alcohol within 72 hours prior to study drug administration or intake of grapefruit or Seville oranges within 7 days prior to the administration of study drug.
• •Strenuous physical exercise within 48 hours prior to study drug administration.
• •Administration of any over-the-counter medication, dietary supplements, or vitamins within 7 days prior to study drug administration. Excluded from this list is nondaily use of acetaminophen at doses of ≤2 grams over a 24-hour period.
• •Administration of prescription drugs or herbal supplements within 14 days prior to study drug administration.
• •-.Exposure to any investigational agent within 30 days prior to the Screening Visit.
• •Any current medical illness, signs, or symptoms that, in the investigator's opinion, could adversely affect subject safety or study integrity.