Abstract

A first-in-human randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of novel spiroindolone KAE609, to assess the safety, tolerability and pharmacokinetics in healthy adult volunteers

Highlights

  • New antimalarials are needed to address the threat of emerging artemisinin resistance

  • Systemic exposure in terms of AUCinf increased in a dose-proportional manner over the dose range of 1300 mg

  • KAE609 is a new antimalarial with potential to address artemisinin resistance, and demonstrates a half-life of around 24 hours and dose-proportional increase in systemic exposure

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Summary

Open Access

A first-in-human randomized, double-blind, placebo-controlled, single- and multipleascending oral dose study of novel spiroindolone KAE609, to assess the safety, tolerability and pharmacokinetics in healthy adult volunteers. Joel Leong1*, Ruobing Li2, Jay Prakash Jain, Gilbert Lefèvre, Baldur Magnusson, Thierry Diagana, Peter Pertel. From Challanges in malaria research: Core science and innovation Oxford, UK. From Challanges in malaria research: Core science and innovation Oxford, UK. 22-24 September 2014

Materials and methods
Results
Conclusions
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