SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects

Inclusion Criteria

Subjects must satisfy all of the following criteria at the screening visit (and/or at check-in, where noted):

• Males or females, of any race, between 18 and 65 years of age, inclusive.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive.
• In good health, determined by no clinically significant findings from medical history, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
• Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

Exclusion Criteria

Subjects will be excluded from the study if they satisfy any of the following criteria at the screening visit (or at check-in, where noted):

Medical conditions

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
• History of any surgical (eg, stomach or intestinal surgery or resection) or medical condition that would potentially alter absorption, distribution, metabolism, and/or excretion of orally administered drugs. Uncomplicated appendectomy and hernia repair will be allowed. Cholecystectomy will not be allowed.
• History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose of IMP.
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) values >1.2 × upper limit of normal (ULN).
• Congenital nonhemolytic hyperbilirubinemia (including suspicion of Gilbert's syndrome).
• Hemoglobin value, neutrophil count, and/or lymphocyte count 21 units per week for males and >14 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
• Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in.
• History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
• Smoking >5 cigarettes per day, on average, or use the equivalent tobacco- or nicotine containing products per day.
• Ingestion of poppy seed , Seville orange , star fruit-, or grapefruit containing foods or beverages within 7 days prior to check-in.

Other exclusions

• Receipt of blood products within 2 months prior to check-in.
• Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
• Poor peripheral venous access.
• Subjects who, in the opinion of the investigator (or designee), should not participate in this study.