@article{0202e0c8f4e04f4eb62f49935ef0d8cd,
title = "Pharmacokinetics and Pharmacodynamics of Novel Long-Acting Ropeginterferon Alfa-2b in Healthy Chinese Subjects",
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.",
keywords = "Clinical trial, Healthy population, Pegylated interferon, Phase I",
author = "Huang, {Yi Wen} and Tsai, {Chan Yen} and Tsai, {Chung Wei} and William Wang and Jingjing Zhang and Albert Qin and Chingleou Teng and Bo Song and Wang, {Mei xia}",
note = "Funding Information: This study and the journal{\textquoteright}s Rapid Service Fee was funded by PharmaEssentia Corp. The interpretation and conclusions in this study are based on the authors{\textquoteright} view. Funding Information: This study and the journal?s Rapid Service Fee was funded by PharmaEssentia Corp. The interpretation and conclusions in this study are based on the authors? view. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. CLT proposed the concept for study and contributed to the design of the study. YWH acted as the medical monitor. YWH, CWT, WW, and JGZ participated in the design of the study, preparation of the protocol, CRF, review of data/analyses, internal and external presentation, as well as preparation of the CSR. YWH and CYT were major contributors in writing the manuscript. BS and MXW were investigators to conduct study and contributed to acquisition, analysis and interpretation of data. YWH, CYT, and AQ contributed to the interpretation of the results and reviewing the manuscript. Bo-Song and Mei-xia Wang were investigators in Beijing Youan Hospital, Capital Medical University, Beijing, China. Chan-Yen Tsai, Chung-Wei Tsai, Albert Qin, and Chingleou Teng work for PharmaEssentia Corporation headquarter in Taipei, Taiwan. William Wang and Jingjing Zhang work for PharmaEssentia Biotech Ltd, Beijing, China. Yi-Wen Huang was the Senior Director of Medical Research and Head of Pharmacovigilance at PharmaEssentia Corporation headquarter in Taipei, Taiwan from July 02, 2018 to May 31, 2021. Yi-Wen Huang moved to Taipei Medical University Hospital. Bo-Song and Mei-xia Wang have nothing to disclose. The study was conducted in accordance with the provisions of the Declaration of Helsinki and its amendments, US Food and Drug Administration (FDA) guidance, and principles of Good Clinical Practice (GCP) from the International Conference on Harmonization (ICH) guidelines. The protocol and informed consent form were reviewed and approved by IRB of Beijing Youan Hospital, Capital Medical University (Protocol Number: A17-101) prior to the screening or enrollment of the study participant. The purpose of the study was explained to the subjects before they provided their written informed consent. Subjects were provided with copies of their signed informed consent forms. At the study center, the clinical staff was available to subjects before they entered the study and throughout their participation in the study to answer questions about the study. Subjects were informed about any new development of the product during the study that might have influenced their continued participation in the study. The data that support the finding of this study are available on request to PharmaEssentia Corp. Publisher Copyright: {\textcopyright} 2021, The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.",
year = "2021",
month = sep,
doi = "10.1007/s12325-021-01863-y",
language = "English",
volume = "38",
pages = "4756--4770",
journal = "Advances in Therapy",
issn = "0741-238X",
publisher = "Health Communications Inc.",
number = "9",
}
