| Autor: |
Jing Xie, Xiaoyun Fan, Yue Su, Huan Zhou, Shugang Cao, Xingyu Zhu, Minhui Zhu, Cuixia He, Ying Wang, Ling Fan, Qin Ge, Juan Zhu, Bingyan Liu, Xiao Chen, Yunqiu Xie, Ling Ma, Yuanyuan Liu, Juan Chen, Huaxue Wang, Zhijun Li |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
Clinical pharmacology in drug development. 11(11) |
| ISSN: |
2160-7648 |
| Popis: |
Telitacicept, an injectable recombinant human B-lymphocyte stimulating factor receptor-antibody fusion protein, is a new dual B lymphocyte stimulator (BLyS)/APRIL (a proliferation-inducing ligand) inhibitor that effectively blocks proliferation of B lymphocytes. This study evaluates the pharmacokinetic characteristics, tolerability, and safety of a single subcutaneous injection of various doses (80, 160, and 240 mg) of telitacicept in healthy Chinese subjects. This trial is a single-center, randomized, open-label phase I clinical study that includes three dose groups (80, 160, and 240 mg) with 12 subjects in each dose group. The subjects were randomly assigned to different dose groups in a 1:1:1 ratio for a single subcutaneous administration trial. After a single dose, the maximum serum concentration (C |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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