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
NCT07430592 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2026-02-27
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.
Conditions
- Malaria
- Malaria Vivax
- Radical Cure
Interventions
- DRUG
-
SJ733/TQ placebo
SJ733 combined with Tafenoquine Placebo
- DRUG
-
CQ/TQ Placebo
Chloroquine combined with Tafenoquine Placebo
- DRUG
-
CQ/TQ
Chloroquine combined with Tafenoquine
- DRUG
-
SJ733 (3-day)/TQ
SJ733 (3-day schedule) combined with Tafenoquine
- DRUG
-
SJ733 (2-day ) /TQ
SJ733 (2-day schedule) combined with Tafenoquine
- DRUG
-
SJ733(1-day)/TQ
SJ733 (1 day schedule) combined with Tafenoquine
Sponsors & Collaborators
-
Global Health Innovative Technology Fund
collaborator OTHER -
Congressionally Directed Medical Research Programs
collaborator FED - collaborator OTHER
-
R. Kiplin Guy
lead OTHER
Principal Investigators
-
Alejandro L Cuentas,, MD, PhD · Asociación Civil Selva Amazónica (ACSA), Iquitos, Loreto - Perú
-
Rodney K Guy, PhD · University of Minnesota
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 76 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-20
- Primary Completion
- 2028-11-20
- Completion
- 2028-11-20
- FDA Drug
- Yes
Countries
- Peru
Study Locations
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