Malaria, Falciparum Clinical Trial
Official title:
A Phase I/II, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study of Sevuparin/DF02, as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
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).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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