Moderate to severe active rheumatoid arthritis
Conditions
Interventions
experimental group:The single-dose dose escalation study is divided into 7 dose groups: 3 mg, 6 mg, 12 mg, 20 mg, 30 mg, 40 mg, 55 mg. Two subjects in the 3 mg dose group (sentinel group) received the
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible to participate in this study must meet the following selection criteria: 1. Healthy volunteers aged 18 to 45 years old are enrolled in the group after menstruation; 2. Male subjects weigh >=50 kg, female subjects >=45 kg, and body mass index (BMI) is 19–26kg/m2 (including both ends); 3. Subjects (including partners) are willing to voluntarily take appropriate and effective contraceptive measures (non-contraceptives) from screening to 6 months after the administration of the test drug, and no sperm or egg donated within 6 months after the administration of the test drug plan; 4. Fully understand this study, volunteer to participate, and have signed a written informed consent form; The subject can communicate well with the researcher, and understand and comply with the requirements of this research.
Exclusion criteria
Exclusion criteria: Subjects can be excluded from any of the following items and not included in the study: 1. Known clinically significant drug allergy history or atopic allergic disease history (asthma, urticaria, eczema dermatitis) or known allergy to experimental drugs or drugs with similar active drugs; 2. Past clinically serious or current clinically significant or clinically significant diseases/abnormalities (including but not limited to nervous system, cardiovascular system, respiratory system, blood and lymphatic system, immune system, kidney, liver, stomach Those with a history of intestinal, metabolic and bone system diseases and malignant tumors, neurological or psychiatric diseases/abnormalities); 3. Frequent history of infections in the past year (number of attacks >=3 times), history of infections within 3 months before administration, such as recurrent oral herpes, genital herpes, herpes zoster and other recurrent viral infections; 4. The abnormal results of physical examination, vital signs, laboratory examinations, and chest radiographs have clinical significance; 5. The white blood cell count, neutrophil count and lymphocyte count in the routine blood examination during screening are below the lower limit of normal value or higher than the upper limit of normal value, and the reticulocyte count and hemoglobin are lower than the lower limit of normal value; 6. Those who tested positive for hepatitis B surface antigen or hepatitis C antibody or syphilis antibody during screening; or HIV antibody was not negative; 7. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) test results are higher than the upper limit of normal; 8. Subjects whose endogenous creatinine clearance rate estimated by serum creatinine level during the screening period is less than 80ml/min (the endogenous creatinine clearance rate formula is Ccr=(140-age) x weight (kg)/[72 x Scr(mg) /dl)] or Ccr=[(140-age) x weight (kg)]/[0.818 x Scr(umol/L)]. The unit of creatinine should be paid attention to during the calculation of endogenous creatinine clear rate. For women, follow the calculation result x 0.85); 9. Those with QTcB> 450 ms during screening (Fridericias formula: QTcB = QT/(RR)1/3), or other abnormal ECGs judged by the investigator as having clinical significance; 10. Those who have undergone any surgery within 6 months before screening; 11. Those who have lost blood or donated more than 400 mL of blood within 3 months before screening, or have received blood or blood component transfusion; 12. Those who have participated in and administered any drug or medical device clinical trial within 3 months before screening (including the placebo group); 13. Those who have received any vaccine within 6 months before screening; 14. Any medications, including prescription drugs, over-the-counter drugs, and herbal medicines, were taken within 1 month before taking the drugs in this study; 15. Those who have a history of drug abuse or have a positive urine drug screening; 16. People who smoked more than 5 cigarettes or equivalent amount of tobacco a day within 3 months before the first administration or who could not quit smoking during the trial period; 17. In the 28 days before the first administration, women drink more than 7 glasses per week or men drink more than 14 glasses per week (1 cup = 5 ounces (150 mL) wine = 12 ounces (360 mL) beer = 1.5 ounces (45 mL) of spirits), Or those who have taken any alcohol-containing products within 48 hou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Pharmacokinetic parameters;Urine concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed