drugset / Trial / NCT01442168
Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sevuparin | Other / unclassified | — | Intravenous |
| Comparator | Atovaquone | Small molecule | — | — |
| Comparator | Proguanil | Small molecule | — | — |