The authors acknowledge the staff at Qilu Pharmaceutical Co., Ltd. (Jinan, China), for the administration of the study protocol and data collection. We thank the staff at Value Pharmaceutical Services Co., Ltd. (Nanjing, China), for the sample assay and PK analysis. We also acknowledge the staff at Guangzhou Jeeyor Medical Research Co., Ltd. (Guangzhou, China), for their support of the statistical analysis. We are grateful to the volunteers who participated in this study.
This study was funded by Qilu Pharmaceutical Co., Ltd., and by grants from the National Major Scientific and Technological Special Project for “Significant New Drugs Development” (2020ZX09201-018). The Rapid Service Fee was supported by a research grant from the Affiliated Hospital of Qingdao University. The authors retained full control of the content of the manuscript. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of data analysis.
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.
Ping-Ping Lin, Chen-Jing Wang, Yan-Ping Liu, Ting Li, Xiao-Meng Gao, Ya-Ping Ma, Ping Shi, Xin Li, Le-Xin Wang and Yu Cao declare no conflict of interest.
Compliance with Ethics Guidelines
This clinical study protocol was approved by the Medical Ethics Committee at the Affiliated Hospital of Qingdao University. All procedures were performed in compliance with the Declaration of Helsinki as well as the International Conference on Harmonization Guideline for Good Clinical Practice. Informed consent was obtained from all volunteers prior to enrollment in the study.
The datasets generated and analyzed during the current study are available in the figshare repository, https://doi.org/10.6084/m9.figshare.13103342.