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Phase 1a, First-In-Human, Dose-Escalation Study of (+)-SJ000557733 (SJ733), an Oral, Novel Inhibitor of Plasmodium Falciparum Plasma Membrane Protein PfATP4
Sponsor study identifier
interventional
44
1 country
1
Study Start
March 1, 2016
Actual (reported)Primary Completion
March 9, 2018
Actual (reported)Study Completion
March 9, 2018
Actual (reported)Malaria is an infectious disease caused by a parasite that is passed to humans when an infected mosquito bites a person. About 3.4 billion people live in areas of the world where malaria is regularly found. In many countries, malaria is one of the leading causes of illness and death. Despite this, there are a limited number of drugs, called antimalarials, that can be used to treat malaria and increasing reports of resistance to existing antimalarials. The purpose of this research study is to test a new experimental antimalarial drug called SJ733 to first assess its safety, tolerability and blood levels in healthy adult volunteers. Single-dose, multi-dose and boosted-dose cohorts (both single and multi-dose) will be studied. The pharmacoenhancer (booster), cobicistat, will be given in combination with SJ733 in the boosted dose-cohorts. PRIMARY OBJECTIVES:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 9, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 19, 2016
Actual (reported)January 22, 2016
Actual (reported)March 1, 2016
Actual (reported)March 9, 2018
Actual (reported)March 9, 2018
Actual (reported)Dose limiting toxicity (DLT)
Number of DLT events will be described at each study dose level. DLT is defined as possibly, probably, or definitely related Grade 4 event, possibly, probably or definitely related Grade 3 event, or possibly, probably, or definitely related Grade 2 methemoglobinemia or anemia (attributed to hemolysis) events.
From baseline up to minimum of 7 days post-dose
Maximum tolerated dose (MTD)
MTD is defined as the dose level prior to the dose cohort that 2 or more Grade 2 methemoglobinemia or anemia (attributed to hemolysis) OR any related Grade 3 OR any Grade 4, study drug adverse event (AE) occurred in.
7 days after the last dose administration
Drug absorption
Drug absorption of SJ733 and its metabolite will be reported.
From baseline through 7 days post-dose
Drug clearance
Drug clearance of SJ733 and its metabolite will be reported.
From baseline through 7 days post-dose
Drug volume of distribution
Drug volume of distribution of SJ733 and its metabolite will be reported.
Drug absorption in the fed cohort
From baseline through 7 days post-dose
Drug clearance in the fed cohort
From baseline through 7 days post-dose
Drug volume of distribution in the fed cohort
From baseline through 7 days post-dose
Area under the curve (AUC) in the fed cohort
From baseline through 7 days post-dose
Time above threshold concentration in the fed cohort
From baseline through 7 days post-dose
Participants will receive SJ733, an investigational drug developed at St. Jude Children's Research Hospital, and cobicistat.
SJ733 is an oral, novel inhibitor of Plasmodium Falciparum plasma membrane protein PFATP4. It will be administered as a single, multi, or boosted oral dose.
Commercially available cobicistat 150 mg tablets will be used. It will be administered as a single oral dose together with SJ733.
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Gaur AH, Panetta JC, Smith AM, Dallas RH, Freeman BB 3rd, Stewart TB, Tang L, John E, Branum KC, Patel ND, Ost S, Heine RN, Richardson JL, Hammill JT, Bebrevska L, Gusovsky F, Maki N, Yanagi T, Flynn PM, McCarthy JS, Chalon S, Guy RK. Combining SJ733, an oral ATP4 inhibitor of Plasmodium falciparum, with the pharmacokinetic enhancer cobicistat: An innovative approach in antimalarial drug development. EBioMedicine. 2022 Jun;80:104065. doi: 10.1016/j.ebiom.2022.104065. Epub 2022 May 19.
Gaur AH, McCarthy JS, Panetta JC, Dallas RH, Woodford J, Tang L, Smith AM, Stewart TB, Branum KC, Freeman BB 3rd, Patel ND, John E, Chalon S, Ost S, Heine RN, Richardson JL, Christensen R, Flynn PM, Van Gessel Y, Mitasev B, Mohrle JJ, Gusovsky F, Bebrevska L, Guy RK. 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. Lancet Infect Dis. 2020 Aug;20(8):964-975. doi: 10.1016/S1473-3099(19)30611-5. Epub 2020 Apr 8.
Aditya H. Gaur, MD
St. Jude Children's Research Hospital
44 participants (actual enrollment reported by the registry).
First Submitted
January 19, 2016
First Posted
January 22, 2016
Study Start
March 1, 2016
Actual (reported)Primary Completion
From baseline through 7 days post-dose
Area under the curve (AUC)
AUC of SJ733 and its metabolite will be reported.
From baseline through 7 days post-dose
Time above threshold concentration
Time above threshold concentration of SJ733 and its metabolite will be reported.
From baseline through 7 days post-dose
Maximum drug concentration (Cmax)
Cmax of SJ733 and its metabolite will be reported.
From baseline through 7 days post-dose
Dose level of SJ733
The dose chosen for the phase 1b trial will be no greater than the MTD and provide an exposure (AUC and time above threshold concentration) that equates (using applicable scaling) with those that provided maximum parasitological effect in the gold standard rodent model.
14 days after the last dose administration
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
March 9, 2018
Actual (reported)Study Completion
March 9, 2018
Actual (reported)Last Updated
January 2, 2019
Record last verified: 2018-12
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Source: ClinicalTrials.gov.
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