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MalariaPhase 2SJ733-2002NCT07430592

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

A Phase 2 study testing CQ/TQ, SJ733 (3-day)/TQ and SJ733 (2-day ) /TQ in people with Malaria and Malaria Vivax, run by R. Kiplin Guy at 1 site in Peru.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 76 years
Conditions the study is for
Malaria, Malaria Vivax, Radical Cure
What is being tested?
CQ/TQ, SJ733 (3-day)/TQ and SJ733 (2-day ) /TQ
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
1 sitePeru
Study dates
Dec 2026to 20 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 76 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body weight between 45 kg and 90 kg inclusive.
  • Presence of mono-infection of P. vivax confirmed by: Fever, as defined by axillary temperature ≥ 37.5°C or oral/rectal/tympanic temperature ≥ 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and, Microscopically confirmed parasite infection: 1,000 to 40,000 asexual parasite count/µL blood
  • Written informed consent provided by participant, in accordance with local practice. If the participant is unable to write, witnessed consent is permitted according to local ethical considerations.
  • Ability to swallow oral medication.
  • Ability and willingness to participate and to comply with the study requirements.
  • Agreement to hospitalization for at least 72 hours and/or until malarial parasites are not detected by microscopy on 2 consecutive occasions.
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  • Agreement to come back to the hospital on Days 4, 7, 14, 21, 28, 35, 42, 60, 120, and 180.
  • A female participant meets eligibility in this study if she is non-pregnant, non-lactating and if she is of: non-childbearing potential defined as: post-menopausal (12 months of spontaneous amenorrhea or <6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL), pre-menopausal and has had a hysterectomy, a bilateral oophorectomy (removal of the ovaries), or a bilateral tubal ligation with medical report verification, negative pregnancy test or, child-bearing potential, with a negative pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 75 days after stopping study treatment:
  • Use of oral, implantable, or injectable hormonal contraceptive, either combined or progestogen alone, used in conjunction with barrier method (condom or diaphragm).
  • Use of an intrauterine device with a documented failure rate of <1% per year.
  • Double barrier method consisting of condom and diaphragm. iv. Male partner who is sterile prior to the female participant's entry into the study and is the sole sexual partner for that female.
  • Complete abstinence from intercourse throughout the study and for a period of 75 days after stopping study treatment.
  • A male participant meets eligibility in this study if he meets one of the following conditions:
  • 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.

Who cannot join

  • Signs and symptoms of severe/complicated malaria according to the World Health Organization Criteria 2010.
  • Mixed Plasmodium infection or Plasmodium mono-infection with any Plasmodium species other than P. vivax.
  • Severe vomiting, defined as more than three times in the 24 hours prior to the planned first dose of drug, or severe diarrhea defined as 3 or more watery stools per day.
  • Severe malnutrition (defined as the weight-for-height being below -3 standard deviation or less than 70% of median of the NCHS/WHO normalized reference values).
  • The presence of a significant medical or psychiatric condition, or any other serious or chronic clinical condition requiring hospitalization, or any other condition that in the opinion of the investigator precludes participation in the study.
  • Female participants must not be lactating or pregnant as demonstrated by a negative serum point-of-care pregnancy test pre-dose (the result of the pre-dose assessment must be confirmed negative prior to dosing).
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  • Employment under the direct supervision of the investigators or study staff.
  • Clinically significant alterations to hematologic or clinical chemistry parameters that in the opinion of the investigator precludes participation in the study, including:
  • 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]
  • Potassium[hypokalemia] ii. Magnesium [hypomagnesemia] e. Hb level < 9 g/dL f. Platelet level < 50,000/mm3
  • Clinically significant alterations to cardiac function
  • 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)
  • Participation in a clinical study of another small investigational molecule within 30 days or investigational biologic within 90 days prior to study enrollment or planning to begin such participation during the study.
  • Received any antimalarial treatment (alone or in combination) in the past containing:
  • Tafenoquine within the previous 4 months
  • Piperaquine, mefloquine, naphthoquine or sulphadoxine / pyrimethamine within the previous 5 months
  • Amodiaquine or chloroquine within the previous 5 months
  • Any artemisinin (artesunate, artemether, arteether or dihydroartemisinin), quinine, halofantrine, lumefantrine and any other anti-malarial treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 3 months.
  • Known history of hypersensitivity, allergic, or adverse reactions to SJ733, tafenoquine or other 8-aminoquinolines, or chloroquine or other 4-aminoquinolines.
  • Current use of prohibited concomitant medications (Appendix III)
  • Known neuropsychiatric disorders.
  • G6PD deficiency <70% normal enzyme activity.
  • Prohibited use of metoclopramide, antibiotics including fluoroquinolones
  • Positive HIV and/or Hepatitis B, C test results

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rodney K Guy, PhD contact

901- 481-7251

rguy@umn.edu

Gaurav Shoeran, PhD contact

gshoeran@umn.edu

Peru1 site

  • Asociación Civil Selva Amazónica (ACSA)

    Iquitos, Loreto

    Ana Rimachi, +51 65 236277, arimachi@acsaperu.org

Other trials in Peru

About this study

Official title: A Phase 2B Trial of the Combination of SJ733 and Tafenoquine for Radical Cure of P. Vivax Malaria in Comparison to Chloroquine-Tafenoquine

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.

Read the detailed description

SJ733-2002 study is a blinded, randomized, placebo- and active comparator-controlled study to examine the safety and efficacy of combining 1, 2, or 3 sequential daily doses of SJ733 with a single dose of TQ given on Day 1 for the radical cure of uncomplicated P. vivax malaria. This study will also establish the role of SJ733 in driving blood stage and liver stage parasite killing and any pharmacological interactions with Tafenoquine (TQ). Hence, this study includes placebo controlled SJ733 and Chloroquine (CQ) monotherapy arms. The six arms in this study will be run simultaneously and participants randomized with a 1:1:1:1:1:1 ratio until all arms are filled. All participants will be monitored for 180 days, with parasitemia endpoints measured on Days 7, 14, 21, 28, 35, 42, 60, 120, and 180 to provide maximum comparability to historical studies. At all times during these studies any participants that develop symptomatic disease or detectable parasitemia will be rescued with local standard-of-care (according to national guidelines). Any participant who does not relapse during the study will be treated following the last day of the study with the same rescue therapy.

Being tested
SJ733/TQ placebo, CQ/TQ Placebo, CQ/TQ, SJ733 (3-day)/TQ, SJ733 (2-day ) /TQ
Keywords
SJ733, SJ733 with Tafenoquine
Medical subject headings
Malaria, Malaria, Vivax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SJ733/TQ placeboDrug

    Also called SJ733, Tafenoquine Placebo

    SJ733 combined with Tafenoquine Placebo

  • CQ/TQ PlaceboDrug

    Also called Chloroquine, Tafenoquine Placebo

    Chloroquine combined with Tafenoquine Placebo

  • CQ/TQDrug

    Also called Chloroquine, Tafenoquine

    Chloroquine combined with Tafenoquine

  • SJ733 (3-day)/TQDrug

    Also called SJ733, Tafenoquine

    SJ733 (3-day schedule) combined with Tafenoquine

  • SJ733 (2-day ) /TQDrug

    Also called SJ733, Tafenoquine

    SJ733 (2-day schedule) combined with Tafenoquine

  • SJ733(1-day)/TQDrug

    Also called SJ733, Tafenoquine

    SJ733 (1 day schedule) combined with Tafenoquine

Study groups in NCT07430592
Study groupRoleWhat they receive
Arm1 - SJ733 600 mg for 3 days and Tafenoquine PlaceboExperimentalSJ733 (600 mg) once a day for 3 consecutive days combined with tafenoquine placebo on the first day
Receives: Drug: SJ733/TQ placebo
Arm 2- Chloroquine and Tafenoquine PlaceboExperimentalChloroquine (600 mg) for 2 consecutive days then Chloroquine (300 mg) for 1 day, combined with tafenoquine placebo on the first day
Receives: Drug: CQ/TQ Placebo
Arm 3 - Chloroquine and TafenoquineActive comparatorChloroquine (600 mg) for 2 consecutive days then Chloroquine (300 mg) for 1 day, combined with tafenoquine (300 mg) once on the first day
Receives: Drug: CQ/TQ
Arm 4a -SJ733 for three days and TafenoquineExperimentalSJ733 (600 mg) once a day for 3 consecutive days combined with tafenoquine (300 mg) once on the first day
Receives: Drug: SJ733 (3-day)/TQ
Arm 4b - SJ733 for 2 days and TafenoquineExperimentalSJ733 (600 mg) once a day for 2 consecutive days, followed by SJ733 placebo for 1 day, combined with tafenoquine (300 mg) once on the first day
Receives: Drug: SJ733 (2-day ) /TQ
Arm 4c - SJ733 for one day and TafenoquineExperimentalSJ733 (600 mg) once, followed by SJ733 placebo for 2 days, combined with tafenoquine (300 mg) once on the first day
Receives: Drug: SJ733(1-day)/TQ

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parasitological Recurrence Free survival (RFS)

    Recurrence free survival (RFS), defined as non-relapses of P. vivax at 180 days given parasitemia clearance at 14 days.

    Measured: 14 - 180 days for each arm

  2. Clinical Recurrence Free Survival

    Absence of malaria-related clinical signs or symptoms over 180 days following confirmed parasitemia clearance at Day 14.

    Measured: 14 to 180 days for each arm

  3. Percentage of patients with treatment related adverse events

    Incidence, severity, drug-relatedness, and seriousness of adverse events

    Measured: 1 to 180 days for each arm

  4. Percent of patients with clinically significant abnormal vital signs

    Number of and seriousness of with clinically significant abnormal vital signs including changes from baseline

    Measured: 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

    Proportion of participants with a decrease in hemoglobin (Hb): > 2 g/dL from baseline to an absolute value of < 7 g/dL

    Measured: 1 to 180 days for each arm

  6. Percent of patients with an Absolute Neutrophil Count < 1000/μL after baseline

    Proportion of participants with an absolute neutrophil count < 1,000/μL after baseline

    Measured: 1 to 180 days for each arm

  7. Percent of patients with significant changes in ECG findings

    Proportion of participants with significant changes in ECG findings, including heart rate, ECG intervals (PR, QTcB, QTcF), conduction changes or abnormalities

    Measured: 1 to 180 days for each arm

  8. Percent of patients with clinically significant increases in venous methemoglobin levels

    Proportion of participants with clinically significant increases in venous methemoglobin levels

    Measured: 1 to 180 days for each arm

Secondary outcomes (4)

  1. Number of participants with signs and symptoms of uncomplicated P. vivax malaria infection

    Proportion of participants with symptoms or physical examination signs related to uncomplicated P. vivax malaria (e.g., headache, nausea, fatigue, fever auxiliary temperature, >/= 37.5 C, chills/shivering/rigors, prostration, conjunctival jaundice, and respiratory distress)

    Measured: 180 days for each arm

  2. Parasite clearance Time

    Parasite Clearance Kinetics in participants with P. vivax malaria infection as measured by Microscopy

    Measured: 72 hours for each arm

  3. Area Under the Plasma Concentration Time Curve (AUC)

    AUC of SJ733, its primary metabolite, SJ506, and tafenoquine

    Measured: 180 days

  4. Maximum Plasma Concentration (Cmax)

    Cmax of SJ733, its primary metabolite, SJ506, and tafenoquine

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2026
  2. Study startDec 2026 (estimated)
  3. Primary completion20 Nov 2028 (estimated)
  4. Study completion20 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A blinded, randomized, placebo- and active comparator-controlled Phase 2b Trial of the Combination of SJ733 and Tafenoquine for Radical Cure of P. vivax Malaria. The study is organized with six arms of participants, randomized across all six arms with 1:1:1:1:1:1 ratio.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07430592
Sponsor's protocol ID
108683
Other IDs
PR241297, G2022-218
Acronym
SJ733-2002
Status last verified
Oct 2026
First submitted
18 Feb 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • uy, R. K. 2023. "NCT04709692: Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria." In. https://clinicaltrials.gov/ct2/show/NCT04709692?term=SJ733&draw=2&rank=2.

  • 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.

    PubMed 35598441

  • 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.

    PubMed 32275867

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CQ/TQ, SJ733 (3-day)/TQ and SJ733 (2-day ) /TQ in people with Malaria and Malaria Vivax, run by R. Kiplin Guy at 1 site in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rodney K Guy, PhD (901- 481-7251, rguy@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parasitological Recurrence Free survival (RFS) (time frame: 14 - 180 days for each arm). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07430592, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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