This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to evaluate the Pharmacokinetics and safety of Telitacicept Pre-filled Injection and Freeze-dried powder Injection.
18-50 years old at the time of signing the informed consent form，gender is unlimited；
Male Weight 55-70 kg, female Weight 50-65 kg, and BMI ranging from 18 to 28 kg/m2 (including critical values);
Physical examination, vital signs, chest radiographs, ECG, epidemiologic tests, routine blood tests, blood biochemistry, lipids, urinalysis, and coagulation are normal，or abnormal by the investigator as having no clinical significance；
Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and be able to complete all trial procedures according to the trial requirements.
Site staff and family members directly involved in the trial; or sponsor staff and family members directly involved in the implementation of the trial;
History of any of any nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood and lymphatic system, skeletal muscle system, immune system, metabolic system disease, or other diseases that are not suitable for clinical trials (such as mental history, malignant tumors, etc.);
History of lymphoproliferative disease (e.g., EB virus associated lymphoproliferative disease), lymphoma, leukemia, myeloproliferative disease, multiple myeloma, or signs and symptoms suggestive of lymphoproliferative disease;
History of abnormal bleeding or coagulation disorders (such as prone to bruising, gingival bleeding, prolonged bleeding after tooth extraction, joint hemorrhage, heavy menstruation leading to anemia within 1 year, postpartum hemorrhage, vitamin K deficiency, hemorrhagic disease caused by acquired coagulation factor antibodies, bleeding after trauma or surgery, etc.) , or abnormal laboratory coagulation parameters, or an inherited tendency to bleed or have coagulation dysfunction, or have a history of blood clots or bleeding, or require long-term use of anticoagulants or antiplatelet aggregation drugs;
Parallel
Telitacicept Pre-filled Injection 80mg
DrugThe patient received one treatment of Telitacicept 80mg in the test group
Telitacicept Freeze-dried powder Injection 80mg
DrugThe patient received one treatment of Telitacicept 80mg in the test group
C-max
Maximum observed plasma concentration
AUC0-∞
Area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
T-max
Time to reach maximum observed plasma concentration
Evaluation of AEs (adverse events)
Through observing number of total AEs and number of subjects with AEs and other factors of AEs #to evaluate the safety and tolerance of healthy subjects.
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