Journal article
Safety, tolerability, pharmacokinetics, and antimalarial efficacy of a novel Plasmodium falciparum ATP4 inhibitor SJ733: a first-in-human and induced blood-stage malaria phase 1a/b trial
Aditya H Gaur, James S McCarthy, John C Panetta, Ronald H Dallas, John Woodford, Li Tang, Amber M Smith, Tracy B Stewart, Kristen C Branum, Burgess B Freeman, Nehali D Patel, Elizabeth John, Stephan Chalon, Shelley Ost, Ryan N Heine, Julie L Richardson, Robbin Christensen, Patricia M Flynn, Yvonne Van Gessel, Branko Mitasev Show all
Lancet Infectious Diseases | Elsevier | Published : 2020
Abstract
Background: (+)-SJ000557733 (SJ733) is a novel, orally bioavailable inhibitor of Plasmodium falciparum ATP4. In this first-in-human and induced blood-stage malaria phase 1a/b trial, we investigated the safety, tolerability, pharmacokinetics, and antimalarial activity of SJ733 in humans. Methods: The phase 1a was a single-centre, dose-escalation, first-in-human study of SJ733 allowing modifications to dose increments and dose-cohort size on the basis of safety and pharmacokinetic results. The phase 1a took place at St Jude Children's Research Hospital and at the University of Tennessee Clinical Research Center (Memphis, TN, USA). Enrolment in more than one non-consecutive dose cohort was allo..
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Funding Acknowledgements
Global Health Innovative Technology Fund, Medicines for Malaria Venture, and the American Lebanese Syrian Associated Charities.