Safety and Activity of Oral HPBCD in Coronary Artery Disease

Exclusion Criteria29

• History of any significant cardiac event or procedure within 3 months prior to Screening, including:
• Acute coronary syndrome or myocardial infarction
• Coronary revascularization procedure
• Clinically significant electrocardiogram (ECG) abnormalities, including but not limited to conduction abnormalities or atrial fibrillation
• Insulin-dependent diabetes mellitus Type 1 or Type 2, or hemoglobin A1c lower than or equal to 9.5%
• Systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 100 mmHg despite antihypertensive medication
• Donation or loss of blood greater than or equal to 450 mL within 8 weeks prior to screening
• Clinically significant laboratory abnormalities, including:
• Aspartate transaminase (AST) or alanine transaminase (ALT) > 3 × upper limit of normal (ULN)
• Total bilirubin > 1.5 × ULN
• Fasting serum triglycerides greater than or equal to 500 mg/dL
• LDL cholesterol lower than or equal to 40 mg/dL
• HDL cholesterol > 80 mg/dL
• Hemoglobin < 11.0 g/dL
• Platelet count < 150,000/µL
• Thyroid-stimulating hormone (TSH) > 1.5 × ULN
• Any physical or psychiatric condition which at the Investigator’s discretion may put the
• participant at risk, may confound the trial results, or may interfere with participation in
• this clinical trial.
• The participant is pregnant or breastfeeding.
• History of any malignancy (other than basal cell carcinoma of the skin or in situ cervical
• cancer) within the past 5 years.
• Cognitive, psychological, or addictive conditions (including alcoholism or drug/ chemical abuse) that, in the opinion of the Investigator, may interfere with participant compliance,put the participant at risk, or preclude informed consent.
• Current use of bile acid sequestrants or cholesterol absorption inhibitors (for example, ezetimibe).
• Current enrollment or past participation in another investigational study in which an investigational intervention (for example, drug, vaccine, and invasive device) was administered within 30 days or 5 half-lives, whichever is longer, of screening in this clinical study.
• Positive blood screen for hepatitis B surface antigen or core antibody, hepatitis C antibody, or human immunodeficiency virus 1 or 2 antibodies.
• Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins (thyroid replacement therapy can be included if on stable dose for at least 12 weeks prior to screening and TSH level is within normal limits).
• Planned surgery or coronary angiography/intervention during the time of study participation; any major surgery within 6 weeks of screening, or surgical or medical condition which might jeopardize participant’s safety.
• Sensitivity to the study drug, or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study.