Materials and Methods
This study was conducted in full accordance with the Declaration of Helsinki and Good Clinical Practice guidelines and applicable national and local laws and regulations. This study has been registered in Chinese Clinical Trial Registry (ChiCTR) as ChiCTR1800017978 and Drug Trial Registration and Information Publication Platform (chinaDrugtrials.org.cn) as CTR20181466.
This study was performed in Phase I Clinical Trial Center, Beijing Shijitan Hospital affiliated with Capital Medical University ,Beijing, China, approved by the Independent Ethics Committee of participating institutions. All study participants provided signed informed consent and had the right to withdraw their consent at any time, without giving reason and without detriment.