Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection

Inclusion Criteria:

• Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
• The body mass index (BMI) is in the range of 19.0~28.0 kg•m-2 (including both ends),and the weight of men is generally not less than 50kg, while the women is generallynot less than 45kg
• Male participants and their partners or female participants must agree to take one ormore non-drug contraceptives (such as complete abstinence, contraceptive rings,partner ligation, etc.) , and there is no sperm donation or egg donation plan until 3months after finished the study
• Participants should fully understand the purpose, nature, methods and possible adversereactions of the trial, volunteer to participate in the trial and sign the informedconsent
• Participants could communicate well with the researchers and compliance with the trial

Exclusion Criteria:

• Those who are allergic to the study drug and any of its excipients. Subjects who havea history of allergy to monoclonal antibodies
• Subjects who have or are currently suffering from any serious clinical diseases 3-6months before screening, such as circulatory system, endocrine system, nervous system,digestive system, respiratory system, urogenital system, hematology, immunology,psychiatry and metabolic abnormalities or any other that can interfere with the studyresults
• Clinical laboratory examinations (blood routine, urine routine, blood biochemistry,coagulation function, etc.), auxiliary examinations (chest X-ray, abdominalultrasound) found to be abnormal and have clinical significance
• Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb),anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
• Alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), orthose who have a positive alcohol breath test (screening period or baseline period) orcouldn't prohibit alcohol during the trial
• Those who smoked more than 5 cigarettes per day during the 3 months before screening,or have a positive urine nicotine screening test (screening period or baseline period)
• Drug abusers or those who have used soft drugs (such as marijuana) within 3 months ortook hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial,or have positive drug abuse screening (morphine, Ketamine, tetrahydrocannabinol acid,methamphetamine , dimethyldioxyamphetamine, cocaine)
• Has taken any prescription medicine, non-prescription medicine, Chinese patentmedicine within 14 days before administration
• Has received any monoclonal antibody drugs within 3 months before administration
• Has a history of vaccination within 3 months before dosing, or intend to receivevaccines during the study
• Was previously enrolled in other clinical trials within 3 months before dosing
• Blood donors or subjects who lost a lot of blood (> 400 mL, except for women'sphysiological period) or those who received blood transfusion or used blood productswithin 3 months
• Can't tolerate venipuncture or has a history of halo needles and halo blood
• Has known or suspected pregnancy or lactation
• Abnormal vital signs (SBP <90 mmHg or ≥140 mmHg, DBP <55 mmHg or ≥90 mmHg; heart rate <50 bpm or> 100 bpm; body temperature <35.4℃ or > 37.3℃) or abnormal ECG (QTcF ≥450ms) or physical examination are clinically significant (according to the judgment ofclinical research doctors)
• Those who are infected and need to be treated for acute or chronic infections, asfollows:
• Suffering from herpes zoster within 12 months before screening;
• Currently in any inhibitory treatment for chronic infections (eg, tuberculosis,pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster virus, andatypical mycobacteria);
• A history of tuberculosis or contact with patients with open tuberculosis in thepast 6 months,or a T-spoT-positive results;
• Infected with parasites within 3 months before administration;
• Hospitalized for infectious diseases within 30 days before administration;
• Received anti-infective drugs (including antibacterial, antiviral, antifungal, orantiparasitic drugs) by parenteral administration (iv or im) 30 days beforeadministration
• Subjects who are unsuited to the study for any reason, judged by the investigators