Rheumatoid Arthritis
Conditions
Interventions
1mg group:Single intravenous infusion
5mg group:Single intravenous infusion
10mg group:Single intravenous infusion
20mg group:Single intravenous infusion
60mg group:Single intravenous infusion
80mg group:Single intravenous infusion
100mg group:Single intravenous infusion
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female subjects aged 18 to 45 years; 2) Weight: female body weight = 45 kg, male body weight = 50 kg, subject body mass index (BMI) between 19 and 24 kg / m2 (including the boundary value); 3) Pre-test physical examination, blood routine, urine routine, stool routine, liver and kidney function and related laboratory tests are normal or the test indicators are mildly abnormal, but the researchers believe that there is no clinical significance; 4) Subjects must give informed consent to the study prior to the trial and voluntarily sign a written informed consent form; 5) Subjects are able to communicate well with the investigator and are able to complete the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to this product or any of its excipients (disodium hydrogen phosphate, sodium dihydrogen phosphate and mannitol), and those with a history of drug, food, and pollen allergy; 2. Those who have had clinically significant diseases or have undergone surgery within 4 weeks before the test; 3. Have any clinically serious disease history or have circulatory, endocrine, neurological or hematologic (especially any hemolytic disease such as glucose-6-phosphate dehydrogenase (G6PD) deficiency or paroxysmal sleep A history of hemoglobinuria , immunology, psychiatric diseases, and metabolic abnormalities; 4. Those who have suffered from gastrointestinal and liver and kidney diseases (for example, those who have undergone partial liver, kidney or gastrointestinal resection); 5. There is a fever in the first three days of screening; 6. The laboratory examination (blood routine, urine routine, blood biochemical examination, etc.) in the screening period within 2 weeks before the test is judged by the clinician as having abnormal clinical significance, including: (1) elevated serum immunoglobulin (IgE), ie >100.00; (2) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times N (N is equal to the upper limit of normal), ie ALT > 75U/L (male) or ALT > 60U/L (female), AST > 60U/L (male) or AST>52.5 U/L (female), or creatinine above the upper limit of normal, or total bilirubin or direct bilirubin to be more than 1.2 times the upper limit of normal; (3) Blood routine examination: white blood cells (WBC) 9.5×10^9/L; Neutrophil (ANC) 175g/L (male) or >150g/L (female); (4) Tumor markers (CEA, AFP, tPSA , CA125, CA153 ) are abnormal and are clinically significant as judged by the investigator; (5) abnormal blood coagulation, which is clinically meaningful by the investigator; 7. Before the test, the electrocardiogram and vital signs were diagnosed as abnormal by the clinician (systolic blood pressure 100bpm), history of orthostatic hypotension By; 8. Hepatitis B surface antigen, hepatitis C antibody, HIV antibody, anti- Treponema pallidum antibody, tuberculin test positive test; 9. Alcoholics or those who regularly drink alcohol within 6 months before the test, that is, drinking more than 28 units of alcohol per week (1 unit = 285ml beer or 25ml spirits or 1 glass of wine), or alcohol within 24 hours before receiving the test drug Those who test positive for breath test; 10. smokers who smoked more than 5 cigarettes per day or equivalent in the first 3 months of the trial, or who used any tobacco products during the trial period; 11. Upon inquiry, those who have a history of drug abuse or drug abuse; or those who are positive for drug abuse urine screening; 12. Those who are allergic to any medicine, food or have special dietary requirements and cannot follow the unified diet; 13. Drinking excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more) per day; 14. Those who have taken prescription or over-the-counter drugs within the first two weeks of screening; 15. Those who took any clinical trial drugs or participated in any drug clinical trial within 3 months prior to enrollment; 16. Blood donation of 360ml or more in the first three months of screenin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicator;Safety indicator; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic index;Pharmacokinetic index; | — |
Countries
China
Contacts
Public ContactYi Fang
Peking University People's Hospital
Outcome results
None listed