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Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria

NCT04709692 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-12-04

Study results available
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Summary

This Phase 2a trial recruits adult patients with uncomplicated P. vivax or P. falciparum blood-stage malaria mono-infection. The study drug SJ733 will be administered to examine its antimalarial efficacy, safety, and tolerability. This study also evaluates whether or not a fixed dose of the pharmacoenhancer cobicistat when given in combination with SJ733 significantly improves drug efficacy.

Conditions

  • Malaria, Falciparum
  • Malaria, Vivax

Interventions

DRUG

(+)-SJ000557733 (SJ733)

Anti-Malarial

Sponsors & Collaborators

  • Global Health Innovative Technology Fund

    collaborator OTHER

  • Eisai Inc.

    collaborator INDUSTRY

  • Asociacion Civil Selva Amazonica

    collaborator OTHER

  • R. Kiplin Guy

    lead OTHER

Principal Investigators

  • Alejandro L Cuentas, MD, PhD · Asociación Civil Selva Amazónica (ACSA)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2022-04-15
Completion
2022-04-15
FDA Drug
Yes

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04709692 on ClinicalTrials.gov