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Phase I, First-in-Human, Single and Multiple Ascending Dose- and Food-Effect Studies to Assess the Safety, Tolerability and Pharmacokinetics of a Novel Anti-hepatitis B Virus Drug, Bentysrepinine (Y101), in Healthy Chinese Subjects

Crossref DOI link: https://doi.org/10.1007/s40261-020-00909-3

Published Online: 2020-04-10

Published Print: 2020-06

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Liu, Xiaoxue https://orcid.org/0000-0003-1424-5853
Xue, Ling

Zhang, Hua

Xu, Qingqing

Zhang, Shichao

Ma, Sheng

Ding, Xiaoliang

Liu, Linsheng

Dong, Ji

Qian, Lifang

Xia, Wen

Jiang, Kun

Huang, Chenrong

Miao, Liyan
Funding

Funding for this research was provided by:

the National Natural Science Foundation of China (81703619)

the Ministry of Science and Technology of China (No. 2015ZX09101012, No. 2017ZX09304021)

the Science and Technology Cooperation Major Project of Guizhou Province (No. [2015]6002)

National Key New Drug Creation and Manufacturing Program, Ministry of Science and Technology (2017ZX09304-021)

Aosaikang Clinical Pharmacy Foundation (A201723)
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Article History

First Online: 10 April 2020

Compliance with Ethical Standards

:

: This work was supported by the Ministry of Science and Technology of China (No. 2015ZX09101012, No. 2017ZX09304021), the Science and Technology Cooperation Major Project of Guizhou Province (No.[2015] 6002), the National Key New Drug Creation Special Programs (2017ZX09304-021), the National Natural Science Foundation of China (81703619), the research project of Aosaikang Clinical Pharmacy Foundation of the Jiangsu Pharmaceutical Association (A201723) and Bailing Enterprise Group Pharmaceutical Co., Ltd (Guizhou, China).

: Wen Xia and Kun Jiang are employees of Bailing Enterprise Group Pharmaceutical Co., Ltd. All other authors have no conflicts of interest.

: All procedures performed in the study were in accordance with the ethical standards of the principles of Good Clinical Practice (GCP) and with the 1964 Helsinki Declaration and its later amendments. Study protocols and informed consent forms were approved by an independent ethics committee: the Ethics Committee for Clinical Research of the First Affiliated Hospital of Soochow University.

: Written informed consent was obtained from all individual participants included in the studies before commencing any study-related procedures.

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