Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers

Inclusion criteria

• Male subjects between 18 and 65 years of age, inclusive.
• Low-density lipoprotein cholesterol (LDL-C) within the range of 1.8 mmol/L to 4.9 mmol/L, inclusive, at screening.
• Body weight within the range of 63.0 kilograms (kg) to 75.0 kg, inclusive.
• Subjects who are willing maintain current normal diet and physical activity.
• Subjects agree to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, injectable contraceptive medroxyprogesterone or subcutaneous implant contraception, etc.) during the study period and within 6 months after the study drug infusion.
• No history of serious diseases, including (but not limited to) cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurologic, endocrine, pulmonary, hematological, immune disease.
• Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol.

Exclusion criteria

• Subjects who have a history of allergy, or may be allergic to the investigational drug and the related compounds.
• Have used the inhibitors of proprotein convertase subtilisin type 9 (PCSK-9).
• Have clinically relevant abnormalities identified by Vital signs, physical examination, clinical laboratory tests, 12-lead ECG, or chest X-ray, at screening.
• Unwilling to stop any strenuous physical activity (such as weightlifting or long-distance running) within 72 hours before the planned follow-up visit.
• History of hospitalization within 1 month before screening, major surgery within 6 months before screening, or other unstable conditions judged by the investigator.
• The last dose of the previous investigational product which is chemical drug has been given in less than 1 month before administration.
• The last dose of the previous investigational product which is biological drug has been given in less than 3 months before administration.
• Have used any drugs (including over-the-counter drugs or prescription drugs), the last medication is less than 14 days or the last medication is less than 5 half-lives of the drug from the administration day (whichever is longer), or are using any drugs.
• Have used any traditional Chinese medicines, vitamins or drugs or supplements known to affect lipid metabolism within 30 days before administration.
• Have a positive test result of human immunodeficiency virus (Human Immunodeficiency Virus, HIV) antibody, hepatitis B virus surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or syphilis test at screening.
• History of alcohol or drug abuse results within 12 months before screening. Average daily alcohol intake is more than 3 units of alcohol (male) (1 unit≈360mL beer, or 45mL spirits with 40% alcohol content, or 150mL wine), or unwilling to stop drinking 72 hours before administration and throughout the study period, or a positive ethanol breath test at screening, or positive drug screening results by urine at screening.
• unable to abstain from smoking, alcohol and caffeinated beverages within 72 hours before administration and throughout the study period.
• lost blood, donated blood ≥200 ml within 2 months before screening.
• History of organ transplantation or malignant tumor.
• Not suitable for this study in the investigator's opinion.