Li, Xian
Xu, Mengxin
Yang, Jingyi
Zhou, Li
Liu, Lin
Li, Min
Wang, Shasha
Liu, Mei-Qin
Huang, Zhixiang
Zhang, Zhen
Liu, Shuning
Hu, Yunqi
Lin, Haofeng
Liu, Bowen
Sun, Ying
Wu, Qingguo
Shi, Zheng-Li http://orcid.org/0000-0001-8089-163X
Lan, Ke http://orcid.org/0000-0002-0384-8598
Chen, Yu http://orcid.org/0000-0003-1300-4652
Yan, Huimin http://orcid.org/0000-0002-7243-8429
Chen, Yao-Qing http://orcid.org/0000-0002-4659-1550
Funding for this research was provided by:
National Natural Science Foundation of China (92169104, 82341041)
Article History
Received: 11 December 2023
Revised: 6 March 2024
Accepted: 7 April 2024
First Online: 27 April 2024
Competing interests
: The authors declare no competing interests.
: Animal studies were conducted according to the Regulations for Administration of Affairs Concerning Experimental Animals in China, and approved by the Animal Welfare and Ethical Review Committee of Wuhan Institute of Virology (WIV), Chinese Academy of Sciences (CAS) (study numbers WIVA09202101). The infection experiments on BALB/c mice were performed in the Animal Biosafety Level 3 (ABSL-3) Laboratory of Wuhan University, which were approved by the Institutional Animal Care and Use Committee (AUP #WP2022-0044) and the Institutional Biosafety Committee (IBC, Protocol #S0132240E). Human experiment was an open-label, non-controlled pilot study of the investigator-initiated trial, which was reviewed and approved by Shanghai Public Health Clinical Center (approval number 2022-S090-03, registration number ChiCTR2400081625), and conducted from 23 December 2022 to 30 April 2023. Written informed consent was obtained from all SARS-CoV-2 uninfected volunteers. All adverse events were identified according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Any adverse events from the beginning of each dose to 7 days post treatment were taken as the adverse events.