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Article History

Accepted: 4 November 2024

First Online: 2 December 2024

Declarations

:

: This study was funded by NuNerve Pty Ltd, the manufacturer of NUN-004. NuNerve Pty Ltd was involved in the study design, data collection, data analysis and preparation of the manuscript.

: Perry F. Bartlett, Andrew W. Boyd, Michael Gerometta and Leanne T. Cooper are inventors of NUN-004 and are thus listed inventors on granted patents. As such, they have a direct interest in the current clinical trial and a potential pecuniary interest if this drug is commercialised. Robert D. Henderson, Richard Friend and Jing Zhao have no relevant financial or non-financial interests that are directly relevant to the content of this article.

: The study was carried out in compliance with the clinical protocol and approved by an independent ethics committee (The Alfred Human Research Ethics Committee, project 743/20 [HREC/71737/Alfred-2020], approved on 18 December, 2020). The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

: Each participant signed and dated an informed consent form according to the local regulatory and legal requirements and Good Clinical Practices.

: Not applicable.

: The data that support the findings of this study are not openly available because of reasons of commercial sensitivity but may be available from the corresponding author upon reasonable request under an appropriate agreement.

: Not applicable.

: PFB, AWB, MG and JZ contributed to the study concept and design and provided ongoing advice to the clinical trial team when requested. RF and RH were involved in the acquisition of study data. LTC contributed to the custom assay design and development. All authors contributed towards the preparation of the manuscript, and read and approved the final submitted version.