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Pilot phase clinical trial of a wearable, electrochemical aptamer-based patch for continuous drug concentration measurement

Nature Biotechnology (2026)Cite this article

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Abstract

As some drugs have narrow therapeutic windows and high inter-patient exposure variability, they require concentration measurements to ensure their safe and effective dosing. To improve on the current practice of sparse blood sampling, we are developing wearable ‘patches’ bearing electrochemical aptamer-based sensors on small, solid needles. Here we describe a pilot phase trial testing their safety and performance in six healthy human participants. The patches were found to be safe and nearly pain free, and they captured concentrations of vancomycin in the dermal interstitial fluid with 5-minute resolution over 24 hours, although, due to sensor degradation, we primarily describe data from the first 12 hours after insertion. Fitting interstitial fluid and plasma concentrations to compartmental pharmacokinetic models revealed distribution and clearance dynamics that are not detected with current sparse sampling approaches. Patches placed at different bodily sites exhibited consistent trends both within and across participants. With further testing and optimization, including real-time wireless data transmission, such patches could aid precision dosing of vancomycin and other drugs with narrow therapeutic windows. Australian New Zealand Clinical Trials Registry registration: ACTRN12622000280707.

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Fig. 1: EAB sensors were deployed as wearable, minimally invasive ‘patches’.
Fig. 2: Continuous measurements of vancomycin in situ in the dermal ISF of humans.
Fig. 3: Within-patch reproducibility is quite good over the course of the first 12 hours but then degrades.
Fig. 4: ISF pharmacokinetics do not vary systematically between locations on the body.
Fig. 5: ISF vancomycin concentration measurements are well described by a simple, compartmental model that uses only two parameters to capture the ISF timecourses.

Data availability

The data supporting the findings of the study are included in the article and its Supplementary Information. The clinical study protocol is also included as supplementary information, as is a repository link to the custom code employed in this study76. The clinical study (ACTRN12622000280707) can be publicly searched on the Australian New Zealand Clinical Trials Registry. The deidentified individual participant concentration versus time data that underlie the results reported in this article are available in the supplementary information files. Limited further details are available upon request by researchers who provide a methodologically sound proposal. The data will be available beginning 3 months after publication with no end date. Proposals should be directed to info@nutromics.com. To gain access, data requestors will need to sign a data access agreement. Source data are provided with this paper.

Code availability

The custom analytical code used for pharmacokinetic modeling is available via Zenodo at https://doi.org/10.5281/zenodo.17931398 (ref. 76).

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Acknowledgements

The authors acknowledge both our volunteer participants and the many other colleagues, consultants and collaborators who contributed to this effort. This includes the clinical study team at Monash Health (S. Warner, I. De Jong, K. Cabral, D. Suarez-Borinaga and V. Vasquez-Ferriggi), A. Beshiri, Cardinal Bioresearch, G. Chiampas, L. Chiampas, C. Conway, R. Crowder, C. Dejrangsi, R. Day, R. Kirubakaran, H. Mehta, V. Seah, A. Schafer, M. Stojanovic, R. Wilkie, P. Vranes and T. Yahya. Nutromics was awarded a CRC-P grant (Round 6) by the Australian Federal Government, which helped support the studies presented here. J.J.G. also acknowledges the Australian Research Council for an Industry Laureate Fellowship (IL240100091). R.H.B. is an Australian National Industry PhD candidate (award no. 35006).

Author information

Author notes

  1. These authors contributed equally: Marsilea A. Booth, Murat K. Erdal.

Authors and Affiliations

  1. Nutromics Pty Ltd., Brunswick, Victoria, Australia

    Marsilea A. Booth, Murat K. Erdal, Mikel Larson, Emily Birthisel, Mark Friedel, Vinicius R. Gonçales, Ali Alinezhad, Franciele Morawski, Jiezhen Li, Nicholas Hogan, Stanley Teo, Johanna Wordsworth, Sahil Khanna, Jeremy Van Eps, Stuart Boyd, Lucy Dewhirst, Julian Gerson, Dheeraj D’Souza, Wang Yin, Priya Thaivalappil Padmanabhan, Robert H. Batchelor, Ashley Farnkopf, Alastair Hodges & Garry Chambers

  2. School of Chemistry, University of New South Wales, Sydney, New South Wales, Australia

    Marsilea A. Booth, Vinicius R. Gonçales, Ali Alinezhad, Robert H. Batchelor & J. Justin Gooding

  3. Department of Gastroenterology and Hepatology, Monash Health, Melbourne, Victoria, Australia

    Michael Braude & Stephen Pianko

  4. School of Clinical Sciences, Monash University, Clayton, Victoria, Australia

    Michael Braude & Stephen Pianko

  5. Department of Psychology and Brain Sciences, University of California, Santa Barbara, Santa Barbara, CA, USA

    Tod E. Kippin

  6. Monash Institute of Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia

    Carl M. J. Kirkpatrick

  7. Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia

    Sophie L. Stocker

  8. Department of Clinical Pharmacology and Toxicology, St. Vincent’s Hospital, Sydney, New South Wales, Australia

    Sophie L. Stocker

  9. St. Vincent’s Clinical Campus, UNSW Medicine, Sydney, New South Wales, Australia

    Sophie L. Stocker

  10. Sydney Institute for Infectious Diseases, University of Sydney, Sydney, New South Wales, Australia

    Sophie L. Stocker

  11. Departments of BioEngineering and of Chemistry and Biochemistry, University of California, Santa Barbara, Santa Barbara, CA, USA

    Kevin W. Plaxco

Authors
  1. Marsilea A. Booth
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Contributions

M.A.B., M.K.E., S.L.S. and K.W.P. were the primary authors of the manuscript. M.A.B. contributed to the sensor development and calibration. M.K.E. performed the pharmacokinetic modeling, with guidance from S.L.S., C.M.J.K. and K.W.P. G.C. led the engineering and sensor teams, which consisted of M.L., M.A.B., M.F., V.R.G., A.A., F.M., J.L., N.H., S.T., J.W., S.K., J.V.E., S.B., L.D., D.D., W.Y., P.T.P., R.H.B. and A.F. A.H., J.J.G., S.L.S. and K.W.P. contributed supervision and strategic scientific input. E.B., S.P., M.B., C.M.J.K. and S.L.S. performed or guided the design and conduct of the clinical trial. J.G. and T.E.K. performed the animal histology studies.

Corresponding authors

Correspondence to Sophie L. Stocker or Kevin W. Plaxco.

Ethics declarations

Competing interests

M.A.B., M.K.E., M.L., M.F., V.R.G., A.A., F.M., J.L., N.H., S.T., J.W., S.K., J.V.E., S.B., L.D., J.G., D.D., W.Y., P.T.P., R.H.B., A.F. and G.C. are employees of and own equity in Nutromics Pty Ltd., which is focused on the commercialization of EAB sensors for applications in biomedical research and clinical practice. E.B. was formerly an employee of Nutromics. A.H., V.R.G., C.M.J.K., J.J.G., S.L.S. and K.W.P. are paid consultants for and/or own equity in Nutromics Pty Ltd. The other authors declare no competing interests.

Peer review

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Nature Biotechnology thanks the anonymous reviewers for their contribution to the peer review of this work.

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Supplementary information

Supplementary Information

Supplementary Figs. 1−12 and Supplementary Tables 1−8.

Reporting Summary

Supplementary Data

Clinical study protocol.

Source data

Source Data Fig. 1

Applied and estimated concentration values in µg ml−1.

Source Data Fig. 2

Concentration timecourses in plasma and ISF in µg ml−1.

Source Data Fig. 3

Various representative concentration timecourses in plasma and ISF in µg ml−1.

Source Data Fig. 4

Mean concentration timecourses in ISF for various patch positions in µg ml−1.

Source Data Fig. 5

Plasma and mean ISF concentration timecourse for each patch position on each volunteer.

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Booth, M.A., Erdal, M.K., Larson, M. et al. Pilot phase clinical trial of a wearable, electrochemical aptamer-based patch for continuous drug concentration measurement. Nat Biotechnol (2026). https://doi.org/10.1038/s41587-026-03010-w

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