The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects

32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two subjects in the lowest dose group, all of whom received the SHR-1209 without placebo control. The other three groups have 10 subjects in each group, 8 administered SHR-1209 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.

Inclusion criteria

• Age ≥18 and ≤45 years old;
• The body mass index (BMI) should be 19 or greater and < 28kg/m2, the male weigh ≥50.0kg and <90.0kg, and the female weigh ≥45.0kg and <90.0kg;
• Serum LDL-C concentration≥2.0mmol/L and < 4.1mmol/L;
• Fasting triglycerides < 2.3 mmol/L;
• The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication.
• Signed informed consent.

Exclusion criteria

• Subjects determined by the researchers have diseases that affect drug absorption, distribution, metabolism and excretion or low compliance;
• A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
• Serum creatinine exceeded the upper limit of normal value (ULN) during screening;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2 x ULN, or total bilirubin more than 1.5 x ULN during screening;
• Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
• Subjects with previous malignant tumor diseases;
• 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening. etc