Safety and tolerability of a single dose T0001 in Chinese healthy adult volunteers: a first-in-human ascending dose study

Authors

  • Tan Zhang Peking University People’s Hospital, Department of Pharmacy
  • Minjie Zhang Peking University People’s Hospital, Department of Pharmacy
  • Li’an Zu Peking University People’s Hospital, Department of Pharmacy
  • Qian Wang Peking University People’s Hospital, Department of Pharmacy
  • Qi Wang Peking University People’s Hospital, Department of Pharmacy
  • Wei Wang Shanghai Fudan-zhangjiang Bio-Pharmaceutical Co. Ltd, Department of Medicine
  • Yitong Wang Peking University People’s Hospital, Department of Pharmacy
  • Yannan Zang Capital Medical University, Beijing Anding Hospital, Department of Pharmacy
  • Zhenwei Xie Peking University People’s Hospital, Department of Scientific Research
  • Shi Chen Peking University People’s Hospital, Beijing, Department of Rheumatology and Immunology
  • Mei Wang Peking University People’s Hospital, Department of Pharmacy
  • Qingshan Zheng The Center for Drug Clinical Research of Shanghai University of TCM
  • Zhanguo Li Peking University People’s Hospital, Department of Rheumatology and Immunology
  • Guihong Chen Shenzhen Bao’an District Songgang People’s Hospital, Department of Pharmacy
  • Yi Fang Peking University People’s Hospital, Department of Pharmacy https://orcid.org/0000-0002-3547-5829

DOI:

https://doi.org/10.1590/s2175-97902019000418447

Keywords:

T0001, TNF-α, Rheumatoid arthritis, Safety, Tolerability

Abstract

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.

Downloads

Download data is not yet available.

Downloads

Published

2020-12-09

How to Cite

Zhang, T. ., Zhang, M. ., Zu, L. ., Wang, Q. ., Wang, Q. ., Wang, W. ., Wang, Y. ., Zang, Y. ., Xie, Z. ., Chen, S. ., Wang, M. ., Zheng, Q. ., Li, Z. ., Chen, G. ., & Fang, Y. . (2020). Safety and tolerability of a single dose T0001 in Chinese healthy adult volunteers: a first-in-human ascending dose study. Brazilian Journal of Pharmaceutical Sciences, 56, e18447. https://doi.org/10.1590/s2175-97902019000418447

Issue

Section

Article