Pharmacokinetics and Pharmacodynamics of Novel Long-Acting Ropeginterferon Alfa-2b in Healthy Chinese Subjects

Yi Wen Huang, Chan Yen Tsai, Chung Wei Tsai, William Wang, Jingjing Zhang, Albert Qin, Chingleou Teng, Bo Song, Mei xia Wang

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Ropeginterferon alfa-2b is a novel mono-pegylated human recombinant interferon (IFN) with the addition of N-terminal proline covalently attached by a 40-kDa polyethylene (peg) moiety. The present study aimed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) profiles and safety of the product in healthy Chinese. Methods: Forty subjects were enrolled and treated with a single subcutaneous injection of either 180 mcg peg-IFN alfa-2a or 90, 180, and 270 mcg ropeginterferon alfa-2b. Results: The mean Tmax of ropeginterferon alfa-2b was 92–141 h and the elimination half-life was 78–129 h. Dose-related, non-proportional increase in ropeginterferon alfa-2b exposure was observed, which was higher than for peg-IFN alfa-2a. The PD parameters were similar between each dose level of ropeginterferon alfa-2b. The mean Tmax of β2-microglobulin ranged from 118 to 132 h after a single dose of ropeginterferon alfa-2b. The average Emax was 3 mcg/ml in all dose levels and the mean AUEC0–t ranged from 1608 to 1775 h/mcg/ml. The TEAEs were comparable among each treatment group and no death nor drug-related SAE was reported. Conclusion: Ropeginterferon alfa-2b is safe and well tolerated after a single subcutaneous injection up to 270 mcg in healthy Chinese. Clinical Trial Registration: www.chinadrugtrials.org.cn, CTR20190451.

Original languageEnglish
Pages (from-to)4756-4770
Number of pages15
JournalAdvances in Therapy
Volume38
Issue number9
DOIs
Publication statusPublished - Sep 2021

Keywords

  • Clinical trial
  • Healthy population
  • Pegylated interferon
  • Phase I

ASJC Scopus subject areas

  • Pharmacology (medical)

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