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Article History

Received: 15 December 2025

Accepted: 12 March 2026

First Online: 28 March 2026

Declarations

:

: G.F. is a former employee of Leadiant Biosciences. A.M.E. and S.E.R. received institutional research funding by Leadiant Biosciences for the conduct of the clinical trial and pharmacokinetic analysis associated with this work. T.R.M., K.L.F., J.C. and P.W. declare no conflicts of interest.

: The clinical trial and pharmacokinetic analysis were funded by Leadiant Biosciences, Inc. Leadiant Biosciences, Inc. provided input into the study design; however, they were not involved in data collection, analysis or interpretation. No funding was received for manuscript preparation.

: T.R.M., K.L.F., A.M.E., G.F. and S.E.R. conceived and designed the work; T.R.M., K.L.F., J.C., P.W. and S.E.R. acquired the data; T.R.M. analysed the data; T.R.M., A.M.E. and S.E.R. interpreted the data; T.R.M., A.M.E. and S.E.R. drafted the manuscript. All authors critically reviewed the manuscript for important intellectual content and approved the final version to be published. J.C. and P.W. were the clinical investigators for this study and had direct clinical responsibility for the participants.

: The data that support the findings of this study are available from the corresponding author upon reasonable request.

: The clinical trial was reviewed and approved by the University of South Australia Human Research Ethics Committee (Reference: 203235). The study was conducted in accordance with the Declaration of Helsinki and applicable local regulations.

: Study participants were fully informed of the study procedures and provided written informed consent prior to study initiation.

: Not applicable.