New malaria combo aims to stop relapses for good
NCT ID NCT07430592
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This Phase 2b trial tests whether a new drug, SJ733, combined with tafenoquine can cure P. vivax malaria and prevent it from returning. About 104 adults with uncomplicated malaria will receive different schedules of SJ733 plus tafenoquine, or standard chloroquine plus tafenoquine. The study will check if the combination clears the parasite and keeps it away for 180 days, while monitoring for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SJ733 and tafenoquine
- What this could lead to
- If successful, this could provide a shorter, more effective treatment to cure P. vivax malaria and prevent it from coming back.
- What could go wrong
- This is an early Phase 2b trial with only 104 participants. The combination may not work better than existing treatments, and side effects like anemia or low white blood cell counts are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 76 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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: i. Use of oral, implantable, or injectable hormonal contraceptive, either combined or progestogen alone, used in conjunction with barrier method (condom or diaphragm). ii. Use of an intrauterine device with a documented failure rate of \<1% per year. iii. 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. v. 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: 1. is sterile prior to participating in the study. 2. 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. 3. agrees to complete abstinence from intercourse throughout the study and for a period of 75 days after stopping study treatment. Exclusion Criteria: * 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). * 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: 1. AST/ALT \> 3 x upper limit of normal range (ULN) and total bilirubin is normal. 2. AST/ALT \> 2 x ULN and total bilirubin is \>1 and \<2 x ULN and conjugated bilirubin is \> 2x ULN. 3. Serum creatinine levels \> 2 x ULN 4. Uncorrected electrolyte abnormalities \[\> 3x ULN or LLN\] i. Potassium\[hypokalemia\] ii. Magnesium \[hypomagnesemia\] e. Hb level \< 9 g/dL f. Platelet level \< 50,000/mm3 * Clinically significant alterations to cardiac function 1. Unstable angina with elevated serum cardiac biomarkers, ECG changes, etc.; those with NSTE-ACS, NSTEMI, STEMI, or definite acute coronary syndrome. 2. Congestive heart failure 3. Recent history of Myocardial Infarction 4. 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: 1. Tafenoquine within the previous 4 months 2. Piperaquine, mefloquine, naphthoquine or sulphadoxine / pyrimethamine within the previous 5 months 3. Amodiaquine or chloroquine within the previous 5 months 4. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asociación Civil Selva Amazónica (ACSA)
Iquitos, Loreto, Peru
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