Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 10:06 PM
Study NCT ID:
NCT07430592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
R. Kiplin Guy
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SJ733-2002
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: