Xu, H. T.
Zimmerman, J.
Bertoch, T.
Chen, L.
Chen, P. J.
Onel, E.
Article History
Received: 20 February 2024
Accepted: 13 April 2024
First Online: 7 May 2024
Declarations
:
: The authors declare no conflict of interest. PJ Chen, Erol Onel, Lee Chen and Hanghang Tommy Xu are employees of Cali Biosciences.
: The original protocol and amendment, informed consent form (ICF), and all other written documents provided to subjects were reviewed and approved by the Advarra Institutional Review Board (IRB) prior to initiation of the study.
: The study included human participants and has been performed in accordance with US and international standards of Good Clinical Practice (GCP) (FDA regulations 21 CFR 312 for IND studies and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [ICH] Guideline E6).
: All subjects were provided with an ICF describing this study with sufficient information for them to make an informed decision about their participation in this study. Written consent was obtained before any subject was submitted to any study procedure. Documentation of the informed consent process, including the date of the ICF signature, was recorded in the subject’s source documents.