He, Handan
Wu, Jinzi J.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC42, a Novel Farnesoid X Receptor Agonist
https://doi.org/10.1007/s40268-023-00444-4
Funding for this research was provided by:
Gannex
Article History
Accepted: 19 September 2023
First Online: 2 November 2023
Declarations
:
: This study was sponsored by Gannex Pharma Co., Ltd. Gannex Pharma was involved with the study design, statistical analysis, interpretation of data, decision to publish, and preparation of the manuscript.
: H.H. and J.J.W. are employees and stock/shareholders of Gannex Pharma.
: This study was conducted in conformance with good clinical practice (GCP) standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
: Written informed consent was obtained from each subject at the screening visit prior to the initiation of any study-related procedures. The investigator or designee explained the study procedures, risks, and potential benefits if any. Subjects reviewed the study instructions and informed consent form (ICF), and were given the time and opportunity to have any questions concerning the conduct of the study, with all answered to their satisfaction.
: Not applicable.
: Any additional information required to reanalyze the data reported in this paper is available from the corresponding author upon request from the publication of the paper. Requests for data sharing will be responded to within 2–3 weeks.
: Jinzi J. Wu: design and conduct of the study including safety surveillance; interpretation of results; critical review and revision of the manuscript; and approval of the final manuscript for submission. Handan He: PK, PD, and biomarker statistical analyses; interpretation of results; and critical review and revision of the manuscript.