drugset / Trial / NCT01442168

Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria

NCT01442168

Phase 1/2 Terminated 53 enrolled Modus Therapeutics AB University of Oxford · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected erythrocyte sequestration and rosette formation. The study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone (part 2).

Timeline

Start
2011-09
Primary completion
2013-09
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sevuparin Other / unclassified Intravenous
Comparator Atovaquone Small molecule
Comparator Proguanil Small molecule