Safety and tolerability of a single dose T0001 in Chinese healthy adult volunteers: a first-in-human ascending dose study
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 Chine...
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| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Book |
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Universidade de São Paulo,
2020-12-01T00:00:00Z.
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|---|---|---|---|
| 001 | doaj_65c7f4c101314d34b9ed72e2da5438a8 | ||
| 042 | |a dc | ||
| 100 | 1 | 0 | |a Tan Zhang |e author |
| 700 | 1 | 0 | |a Minjie Zhang |e author |
| 700 | 1 | 0 | |a Li'an Zu |e author |
| 700 | 1 | 0 | |a Qian Wang |e author |
| 700 | 1 | 0 | |a Qi Wang |e author |
| 700 | 1 | 0 | |a Wei Wang |e author |
| 700 | 1 | 0 | |a Yitong Wang |e author |
| 700 | 1 | 0 | |a Yannan Zang |e author |
| 700 | 1 | 0 | |a Zhenwei Xie |e author |
| 700 | 1 | 0 | |a Shi Chen |e author |
| 700 | 1 | 0 | |a Mei Wang |e author |
| 700 | 1 | 0 | |a Qingshan Zheng |e author |
| 700 | 1 | 0 | |a Zhanguo Li |e author |
| 700 | 1 | 0 | |a Guihong Chen |e author |
| 700 | 1 | 0 | |a Yi Fang |e author |
| 245 | 0 | 0 | |a Safety and tolerability of a single dose T0001 in Chinese healthy adult volunteers: a first-in-human ascending dose study |
| 260 | |b Universidade de São Paulo, |c 2020-12-01T00:00:00Z. | ||
| 500 | |a 2175-9790 | ||
| 500 | |a 10.1590/s2175-97902019000418447 | ||
| 520 | |a 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 in sixteen subjects were recorded, and eighteen of these AEs were believed to be related to T0001. The most frequently reported AEs were injection site reactions and white blood cell count increase. All these AEs were of mild to moderate intensity and most of them recovered spontaneously within 14 days. In this study, no dose-limiting toxicity was observed, and the maximum tolerated dose was identified as 75 mg. T0001 was considered safe and generally well tolerated at doses up to 75 mg in healthy Chinese volunteers. | ||
| 546 | |a EN | ||
| 690 | |a T0001 | ||
| 690 | |a TNF-α | ||
| 690 | |a Rheumatoid arthritis | ||
| 690 | |a Safety | ||
| 690 | |a Tolerability | ||
| 690 | |a Pharmacy and materia medica | ||
| 690 | |a RS1-441 | ||
| 655 | 7 | |a article |2 local | |
| 786 | 0 | |n Brazilian Journal of Pharmaceutical Sciences, Vol 56 (2020) | |
| 787 | 0 | |n http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502020000100598&tlng=en | |
| 787 | 0 | |n https://doaj.org/toc/2175-9790 | |
| 856 | 4 | 1 | |u https://doaj.org/article/65c7f4c101314d34b9ed72e2da5438a8 |z Connect to this object online. |