Systemic lupus erythematosus
Conditions
Interventions
Telitacicept for injection:The drug was administered subcutaneously to the front of the thigh. The eligible subjects were randomly assigned to receive a single subcutaneous injection of 80mg of Telita
Telitacicept injection:The drug was administered subcutaneously to the front of the thigh. The eligible subjects were randomly assigned to receive a single subcutaneous injection of 80mg of Telitacice
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-50 years old at the time of signing informed consent, male to female ratio is not limited; (2) Male weight 55-70 kg (including cut-off value), female weight 50-65 kg (including cut-off value), body mass index (BMI) is required to be within the range of 18.5-26 kg/m2 (including cut-off value); (3) Physical examination, vital signs, chest radiography, electrocardiogram, infectious disease examination, blood routine, blood biochemistry, blood lipids, urine routine, coagulation function important indicators were normal or the investigator judged that the abnormality had no clinical significance; (4) Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete all the trial processes according to the trial requirements.
Exclusion criteria
Exclusion criteria: (1) Site staff and their family members directly involved in the conduct of the study, or sponsor staff and their family members directly involved in the conduct of the study; (2) Previous or present serious nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood and lymphatic system, musculoskeletal system, immune system, metabolic disorders and other diseases that are not suitable for participating in clinical trials (such as mental illness, malignant tumors, etc.); (3) History of lymphoproliferative disease (such as Epstein-Barr virus-related lymphoproliferative disease), lymphoma, leukemia, myeloproliferative disease, multiple myeloma or signs and symptoms suggestive of current lymphoproliferative disease; (4) History of abnormal bleeding or coagulation disorders (such as easy bruising, easy gingival bleeding, prolonged bleeding after tooth extraction, hemarthrosis, menorrhagia leading to anemia within 1 year, postpartum hemorrhage, vitamin K deficiency, acquired coagulation factor antibodies caused by bleeding disorders, trauma or postoperative bleeding, etc.) or abnormal laboratory coagulation parameters, hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis or bleeding, or the need for long-term use of anticoagulants or antiplatelet aggregation drugs; (5) Screening 12-lead ECG showed QTcF = 450 ms in men or QTcF = 470 ms in women, or the presence of second-degree or third-degree atrioventricular block or other clinically significant ECG abnormalities, the investigator judged inappropriate to participate in the study; (6) The subject 's first degree relatives have hereditary immunodeficiency; (7) Current allergic diseases, history of allergy to protein products for treatment or diagnosis, history of allergy to alcohol (alcohol is used for injection site disinfection), and allergy to two or more drugs and/or non-drug factors; (8) Surgery within 6 months before screening, or planned surgery during the trial or within 2 weeks after the end of the trial (including cosmetic surgery, dental surgery and oral surgery, etc.); (9) Participated in other drug clinical trials within 3 months before screening; (10) Use of drugs that inhibit or induce hepatic metabolism of drugs (e.g., inducers — barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors — SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) within 4 weeks before randomization or are required during the trial; (11) Use of prescription drugs, over-the-counter drugs (herbal medicine, vitamins, dietary supplements, fitness steroids and health products), Chinese patent medicines, biological products 14 days or 5 half-lives (whichever is longer) before randomization; (12) Blood loss or blood donation of more than 100 mL within 3 months before screening (female subjects cannot be excluded due to menstrual blood loss), or plans to donate blood during the trial or within 1 month after the end of the trial; (13) Positive breath alcohol test results or alcohol abuse within 6 months before screening (drinking more than 14 standard units per week: 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine), unable to stop drinking during the test; (14) Smoking more than 5 cigarettes/day within 6 months before screening, unable to quit smoking during the t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;Clast;Tlast;?z;t1/2z;AUC0-t;AUC_%Extrap;Vz/F;CLz/F; | — |
Countries
China
Contacts
Public ContactQi Shen
West China Hospital of Sichuan University
Outcome results
None listed