A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

Exclusion Criteria

• •Documented history of homozygous familial hypercholesterolemia (HoFH);
• •Estimated glomerular filtration rate (eGFR)\<30 mL/min/1.73m2;
• •Active liver disease or hepatic dysfunction, history of liver transplant, and/or ALT or AST \>2.5 × ULN at screening;
• •Poorly controlled thyroid disorder including hypothyroidism or hyperthyroidism;
• •Poorly controlled Type 1 or Type 2 diabetes mellitus defined as fasting blood glucose ≥11.0 mmol/L (200 mg/dL) and glycosylated hemoglobin (HbA1c) ≥ 9%;
• •Serious arrhythmia, MI, unstable angina pectoris, PCI, CABG, implantable cardioverter defibrillator, aortic valve surgery or stroke within 3 months prior to the first dose;
• •Planned cardiac surgery or revascularization during the study period;
• •New York Heart Association (NYHA) Class III-IV heart failure;
• •Pregnant or lactating women;
• •Poorly controlled hypertension (SBP≥160 mmHg or DBP≥100 mmHg in a sitting position)
• •Unexplained creatine kinase (CK) \> 5 x ULN (retested once is needed if suspected to be related to excessive exercise or abnormal activity);
• •LDL apheresis or plasma exchange within 2 months prior to the first dose;
• •HIV, Treponema pallidum, or HCV antibody test positive, or HBV-DNA \>ULN at screening;
• •History of prescription drug abuse, illicit drug use or alcohol abuse within 6 months prior to screening;
• •History of any major drug allergy, including allergy to protein biologics;
• •Participate another clinical trial within 30 days or less than 5 half-lifes (drug) before screening, whichever is longer