The PK/PD Study of A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects

Exclusion Criteria

• •Any disease affecting bone metabolism;
• •Past medical history of cerebral infarction or cerebral arterial thrombosis;
• •Past medical history of myocardial infarction;
• •Administration of the following drugs within 6m: Hormone replacement therapy, Calcitonin Parathyroid hormone (or any derivative), Supplemental Vitamin D\>1,000 IU/day, Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed), Anabolic steroids, Calcitriol and available analogues, thiazide diuretics;
• •Administration of the following drugs within 12m: Bisphosphonates, Fluoride for osteoporosis;
• •A bone fracture within the previous 6 months;
• •A lumbar spine L1-L4 or femoral neck T-score ≤-2.5;
• •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT) or total bilirubin, more than 1.5 x ULN during screening;
• •3 months prior to screening involved in any drug clinical subjects;
• •Subjects determined by the researchers have any food, dietary supplement or drugs that affect SHR-1222 absorption, distribution, metabolism and excretion in 4 weeks prior to screening or within 5 half-lives;
• •Serious infection, trauma or major surgery in 4 weeks prior to screening;
• •A surgery plan during the study;
• •Blood donation and transfusion in 3 months prior to screening;
• •Unstable thyroid dysfunction in 6 months prior to screening;
• •Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
• •Intolerant to venous blood collection;
• •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
• •Subjects with any other situation should not be involved, which determined by the researchers.