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Article History

Received: 27 May 2025

Accepted: 8 September 2025

First Online: 30 September 2025

Declarations

:

: This work was produced by the PYRAPREG study which is part of the EDCTP2 program (grant number RIA2017MC-2025-PYRAPREG) and the Global Health EDCTP3 Joint Undertaking (Grant agreement ID: 101145638 PYRAPREG-extended), both programs supported by the European Union. The views and opinions of authors expressed herein do not necessarily state or reflect those of EDCTP. T.D. was supported by the Swedish Research Council (VR 2022-01251).

: J.S. is an employee of Shin Poong Pharm. Co. Ltd, which provided the study drug. Alwin Huitema is an Editorial Board member of Clinical Pharmacokinetics. Alwin Huitema was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. All other authors declare that they have no competing interests relevant to the content of this article.

: The raw data are available upon reasonable request by an email to the corresponding author.

: The model files are provided as supplementary material. Other codes are available upon reasonable request.

: The authors affirm that human research participants provided informed consent for publication of their data.

: U.D.A., K.K., T.D., H.M.M., J.K.T., D.Y., F.A.K., V.M., E.S., A.V., and J.S. contributed to protocol development, study conduct, study registration, recruitment, and data collection. W.S. performed the bioanalysis and measured the study samples. W.C., A.H., and T.D. conducted the PBPK modelling. The manuscript was drafted and reviewed by W.C., A.H., and T.D. All authors reviewed, commented on, and approved the final submitted version of the manuscript.

: The PYRAPREG trial (PACTR202011812241529) was conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval was obtained from the following committees: the Ethics Committee for Health Research in Burkina Faso, the National Health Ethics Committee in the Democratic Republic of Congo, the Ethics Committee of the Faculty of Medicine and Odontostomatology/Faculty of Pharmacy in Mali, the Gambia Government/MRCG Joint Ethics Committee, and the National Bioethics Committee for Health in Mozambique. Written informed consent was obtained from all participants prior to their inclusion in the study. A four-part phase I clinical trial (Protocol number SP-C-001-03) was conducted at the Clinical Trial Center of Seoul National University, Seoul, South Korea, in accordance with Good Clinical Practice (GCP) guidelines and the Declaration of Helsinki. Ethical approval was granted by the Institutional Review Board of Seoul National University. Written informed consent was obtained from each participant prior to study participation.