A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject

Inclusion criteria

• Able and willing to provide a written informed consent.
• Male or non-pregnant, non-lactating female ages 18 to 55 years old.
• Weight ≥ 45 kg, and body mass index (BMI) must range from 18 to 28 kg/m2 .
• Healthy subjects as determined by absence of clinically significant abnormalities on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests performed at screening or baseline period.
• Subjects must be willing to use a highly effective method of contraception as deemed appropriate by the investigator throughout the study and for at least 3 months after the last study drug administration.

Exclusion criteria

• Evidence or history of serious cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurological, haematological, or metabolic diseases within 5 years.
• Subjects with tuberculosis diagnosed by Interferon Gamma Release Assays (IGRA) or chest X-ray.
• Subjects had any surgery within the past 6 months before screening or planned to undergo surgery during the study period.
• Estimated Glomerular Filtration Rate（eGFR）<90 mL/min/1.73m2.
• Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening.
• Systolic blood pressure (SBP) > 140 mm Hg or < 90 mm Hg, or diastolic blood pressure (DBP) > 90 mm Hg or < 60 mm Hg and has been considered clinically significant.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) ≥2.0 x ULN, or total bilirubin ≥1.5 x ULN.
• Clinically significant abnormal 12-lead ECG at screening (male with QTcF > 450 ms or female with QTcF > 470 ms).
• Female subjects who had unprotected sexual behaviour within 14 days before screening.
• Positive for alcohol breath test at screening or baseline period.
• Positive urinary drug test at screening or baseline period.
• Blood collection is difficult or cannot tolerate venipuncture blood collection.
• Allergic to any ingredient or component in the study drug.
• Subjects who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicine within 14 days prior to using the study drug.
• Subjects who smoked more than 5 cigarettes daily in the 1 month before screening.
• History of regular alcohol consumption exceeding 3 units/day for women or 5 units/day for men, more than twice per week (1 unit = 150 ml of beer or 50 ml of wine or 17 ml of alcoholic spirits) within 3 months before screening.
• Participated in any other clinical trials of any drug or medical device within 3 months before screening.
• Donated blood or blood products or had substantial loss of blood (more than 400 mL) within 1 month before screening, or received any blood or blood products within 2 months prior to screening.
• Subjects who received live (attenuated) vaccine within 1 month prior to screening or consider getting a vaccination during the study.
• The employee of investigator or study centre, with direct involvement in the proposed study.
• The investigators determined that other conditions were inappropriate for participation in this clinical trial.