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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Sevuparin 4 times per day and malanil according to label
malanil according to label
Mae Ramat Hospital
Mae Ramat, Changwat Tak, Thailand
Maesot General hospital
Mae Sot, Changwat Tak, Thailand
Hospital for Tropical Diseases
Bangkok, Thailand
Dose limiting toxicities according to specified criteria
Time frame: During treatment and 14 days post treatment follow-up.
Area under the curve of late stage peripheral blood parasitemia over time (Part 2).
Time frame: 72 hours
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