Wu, Xiaojie
Yu, Jicheng
Ge, Beikang
Wang, Jeffrey
Han, Xiaoran
Zhang, Chunye
Mao, Xiaomeng
Kalluru, Hindu
Bramson, Candace
Terra, Steven G.
Liu, Jing
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Randomized, Open-Label, Phase I, Single-Dose Study of Antisense Oligonucleotide, Vupanorsen, in Chinese Adults with Elevated Triglycerides
https://doi.org/10.1007/s40268-024-00467-5
Funding for this research was provided by:
Pfizer
Article History
Accepted: 12 May 2024
First Online: 1 July 2024
Declarations
:
: This study was sponsored by Pfizer.
: XW, JY, and XM are employees of Huashan Hospital, Fudan University, Shanghai, China. No honorarium was paid for this study. BG, XH, CZ, HK, CB, SGT, and JL are employees of Pfizer and may own stock or stock options. JW was a full-time employee of Pfizer at the time of the manuscript development and may own stock or options.
: The study was conducted in compliance with the ethical principles of the Declaration of Helsinki and in compliance with all International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed, in particular those affording greater protection to the safety of trial participants. The final protocol, any amendments, and informed consent documentation were reviewed and approved by the Independent Ethics Committee (IEC) at the investigational center (HIRB approval 2021-070). Investigators were required to inform their IEC of the study’s progress and occurrence of any serious and/or unexpected adverse events.
: All participants gave written informed consent prior to initiation of the study.
: Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See for more information.
: All authors contributed to the analysis, design, and implementation of the study. All authors contributed to the analysis of the results and critically reviewed and approved the manuscript for submission.