Safety and pharmacokinetics of GSK3494245, a highly selective Leishmaniasis kinetoplastid proteasome inhibitor for the treatment of visceral leishmaniasis: A Phase 1, randomized, single ascending dose escalation study in healthy participants

• Mischka Moodley ,

  Roles Formal analysis, Project administration, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing

  * E-mail: mischka.x.moodley@gsk.com

  Affiliation Global Health Medicines R&D, GSK, London, United Kingdom

  https://orcid.org/0000-0002-9494-5720

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• Michalis Kostapanos,

  Roles Formal analysis, Investigation, Project administration, Supervision, Writing – review & editing

  Affiliations GSK Clinical Unit Cambridge, GSK, Cambridge, United Kingdom, Department of Medicine, Addenbrooke’s Hospital, Cambridge University Hospitals and University of Cambridge, Cambridge, United Kingdom

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• Laura Iavarone,

  Roles Conceptualization, Data curation, Formal analysis, Methodology, Software, Validation, Visualization, Writing – review & editing

  Affiliation Clinical Pharmacology, Modeling and Simulation, Parexel, Milan, Italy

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• Marguerite Bracher,

  Roles Formal analysis, Project administration, Visualization, Writing – original draft, Writing – review & editing

  Affiliation Global Health, GSK, Stevenage, Hertfordshire, United Kingdom

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• Silvia M. Lavezzi,

  Roles Conceptualization, Data curation, Formal analysis, Methodology, Software, Validation, Visualization, Writing – review & editing

  Affiliation Clinical Pharmacology, Modeling and Simulation, Parexel, Dublin, Ireland

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• Maria Davy,

  Roles Conceptualization, Methodology, Project administration, Supervision, Writing – review & editing

  Affiliation Global Health, GSK, Stevenage, Hertfordshire, United Kingdom

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• Pooja Singh,

  Roles Formal analysis, Visualization, Writing – review & editing

  Affiliation Global Safety, GSK, Bangalore, Karnataka, India

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• Ramya Bhat,

  Roles Formal analysis, Methodology, Writing – review & editing

  Affiliation Biostatistics, GSK, Bangalore, Karnataka, India

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• Deborah Wong,

  Roles Project administration, Writing – review & editing

  Affiliation Global Clinical Delivery, R&D, GSK, Stevenage, Hertfordshire, United Kingdom

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• Hema Sharma,

  Roles Investigation, Project administration, Supervision, Writing – review & editing

  Affiliation Vaccines Clinical Sciences, GSK, London, United Kingdom

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• Lionel K. Tan,

  Roles Conceptualization, Investigation, Methodology, Supervision, Writing – review & editing

  Affiliation Clinical Development, ViiV Healthcare Ltd., London, United Kingdom

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• Timothy J. Miles

  Roles Conceptualization, Funding acquisition, Supervision, Writing – review & editing

  Affiliation Global Health Medicines R&D, GSK, Tres Cantos, Madrid, Spain

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