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Article History

Received: 4 June 2025

Accepted: 31 August 2025

First Online: 18 October 2025

Declarations

:

: The study was funded by the Austrian Research Promotion Agency (FFG); Project number #881646.

: The study sponsor was the company SCARLETRED Holding GmbH. H.S. is the founder of the company and the inventor of the Scarletred® technology and declares no conflicts of interest pertaining to this publication. R.P. provided financially compensated consulting services for SCARLETRED Holding GmbH. B.V. is employed at Polymun Scientific Immunbiologische Forschung and declares no conflicts of interest pertaining to this publication. D.K. is the CEO of Polymun Scientific Immunbiologische Forschung and declares no conflicts of interest pertaining to this publication. M.Z. is an Editorial Board member of Clinical Pharmacokinetics. M.Z. was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.

: The study was performed in accordance with the Declaration of Helsinki and the Good Clinical Practice Guidelines of the International Conference on Harmonization. The Ethics Committee of the Medical University of Vienna and the Austrian Agency for Health and Food Safety approved the study, and it was registered under the EudraCT number 2022-000173-11.

: After providing oral and written informed consent to participate in the study, the healthy volunteers were assessed for eligibility according to the inclusion and exclusion criteria.

: Data supporting the results reported in the article are not available publicly However, data can be provided on request from the authors.

: V.J., R.P., H.S., and M.Z. wrote the manuscript; M.B., R.P., B.V., D.K., R.B., H.S., and M.Z. designed the research; V.J., M.B., A.J., F.B., and M.WD. performed the research; V.J. analyzed the data; V.J., M.B., A.J., F.B., M.WD, R.P., B.V., D.K., R.B., H.S., and M.Z critically revised the manuscript.

: The noncompartmental analysis was performed using Phoenix WinNonlin (Certara, Princeton, NJ, USA; version X.X). This software is commercially licensed, and its source code is not publicly available. However, all analysis settings and parameters used in this study are available from the corresponding author upon reasonable request.

: Not applicable.