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| Zhang,Tan; Zhang,Minjie; Zu,Li’an; Wang,Qian; Wang,Qi; Wang,Wei; Wang,Yitong; Zang,Yannan; Xie,Zhenwei; Chen,Shi; Wang,Mei; Zheng,Qingshan; Li,Zhanguo; Chen,Guihong; Fang,Yi. |
| T0001 is the first mutant of etanercept with a higher affinity to tumor necrosis factor α (TNF-α) than etanercept. In order to investigate the safety and tolerability of T0001, a study was carried out in healthy Chinese subjects. A first-in-human, dose escalation study was conducted in healthy Chinese subjects. Fifty-six subjects were divided into six dose cohorts (10 mg, 20 mg, 35 mg, 50 mg, 65 mg and 75 mg) to receive a single subcutaneous injection of T0001. Safety and tolerability assessment were based on the records of vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms and adverse events (AEs). All subjects were in good compliance and none withdraw due to AEs. No serious AEs occurred. A total of twenty-three AEs... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: T0001; TNF-α; Rheumatoid arthritis; Safety; Tolerability. |
| Ano: 2020 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502020000100598 |
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