SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research

Inclusion criteria

• Any male or female aged between 18 and 80 on the date of signing the informed consent;
• Diagnosed as hypercholesterolemia ;
• Fasting triglyceride was less than 5.6 mmol/L during screening:
• Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Exclusion criteria

• A history of the following diseases or treatments during the screening period:

• Known allergies to PCSK9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past;
• Participated in clinical studies of other drug interventions within the last 1 month (except for patients who failed in screening), or those who are within 5 half-lives of the drug before screening (whichever is longer);
• Any of the laboratory test indicators meets the following criteria:

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was more than 3 times the upper limit of normal value (ULN), and total bilirubin was more than 2 times ULN during the screening period or at random;
• The creatine kinase (CK) was more than 3 times of ULN during the screening period or at random;
• Have used the following drugs:

• PCSK9 inhibitors had been used in the previous 6 months;
• Continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened.
• Other circumstances:

• Women of reproductive age who are fertile but did not use contraception within 4 weeks before the screening period;Women who are pregnant or breastfeeding;Not agreed during the trial or at 24 weeks after the last dose
• Subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.