Wang, Ping
Liu, Jinrong
Tan, Xiaojuan
Yang, Fred
McCabe, James
Zhang, Jay http://orcid.org/0009-0008-4389-4901
Funding for this research was provided by:
KBP Biosciences
Article History
Accepted: 30 May 2023
First Online: 25 June 2023
Declarations
:
: The authors would like to acknowledge the editorial assistance of Terri Levine, PhD, and Ishita Chatterjee, PhD, of ProPharma Group in the development of this manuscript that was funded by KBP Biosciences USA, Inc., Princeton, NJ in accordance with Good Publication Practice (GPP22) guidelines. The authors thank the volunteers who participated in the clinical studies.
: Participated in research design: Ping Wang, Jay Zhang, Fred Yang. Administrative support for study: Xiaojuan Tan, Jinrong Liu. Performed data analysis: Ping Wang, Jay Zhang. Wrote or contributed to the writing of the manuscript: Ping Wang, Jay Zhang. Medical oversight: James McCabe.
: The nonclinical and clinical DDI studies were supported by KBP Biosciences Co., Ltd., Jinan, China.
: Authors were employees of KBP Biosciences USA, Inc., Princeton, NJ (F. Yang, J. McCabe, J. Zhang) or KBP Biosciences Co., Ltd., Jinan, China. (P. Wang, J. Liu, X. Tan). There were no other competing interests to report.
: The clinical DDI study was conducted in accordance with the protocol and with the consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and applicable laws and regulations. The study was approved by WCG IRB (Study#: 8450126; Approval Date October 13, 2020).
: Informed consent was obtained from all individual participants included in the study.
: Not applicable.
: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
: Custom software or code used during the study are available from the corresponding author on reasonable request.