This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Saf… (NCT07430592) | Clinical Trial Compass
Not Yet RecruitingPhase 2
This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria
Peru104 participantsStarted 2026-03-20
Plain-language summary
The goal of this Phase 2b study is to examine the safety and efficacy of the combination of SJ733, an investigational agent, and tafenoquine for the radical cure of uncomplicated P. vivax malaria monoinfection in adult participants and determine the contributions of SJ733 to the effect. SJ733 will be administered in a 1-, 2-, or 3-day treatment schedule in combination with a single dose of tafenoquine.
Who can participate
Age range18 Years – 76 Years
SexALL
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Inclusion criteria
✓. is sterile prior to participating in the study.
✓. agrees to the use of a contraceptive method (such as a condom) through the administration of study treatment and for a period of 75 days after stopping study treatment.
✓. agrees to complete abstinence from intercourse throughout the study and for a period of 75 days after stopping study treatment.
Exclusion criteria
✕. AST/ALT \> 3 x upper limit of normal range (ULN) and total bilirubin is normal.
✕. AST/ALT \> 2 x ULN and total bilirubin is \>1 and \<2 x ULN and conjugated bilirubin is \> 2x ULN.
✕. Serum creatinine levels \> 2 x ULN
✕. Uncorrected electrolyte abnormalities \[\> 3x ULN or LLN\]
✕. Unstable angina with elevated serum cardiac biomarkers, ECG changes, etc.; those with NSTE-ACS, NSTEMI, STEMI, or definite acute coronary syndrome.
✕. Congestive heart failure
✕. Recent history of Myocardial Infarction
✕. QT prolongation (\>450 milliseconds (ms) in men and 460 ms in women)
What they're measuring
1
Parasitological Recurrence Free survival (RFS)
Timeframe: 14 - 180 days for each arm
2
Clinical Recurrence Free Survival
Timeframe: 14 to 180 days for each arm
3
Percentage of patients with treatment related adverse events
Timeframe: 1 to 180 days for each arm
4
Percent of patients with clinically significant abnormal vital signs
Timeframe: 1 to 180 days for each arm
5
Percent of patients with a decrease in hemoglobin (HB) > 2 g/dL from baseline to an absolute value of <7 g/dL
Timeframe: 1 to 180 days for each arm
6
Percent of patients with an Absolute Neutrophil Count < 1000/μL after baseline
Timeframe: 1 to 180 days for each arm
7
Percent of patients with significant changes in ECG findings
Timeframe: 1 to 180 days for each arm
8
Percent of patients with clinically significant increases in venous methemoglobin levels