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Table 1 Studies of Eurartesim in patients

From: MMV in partnership: the Eurartesim® experience

Study Dose Test regimen Comparator Total no. of subjects Subject type Main efficacy endpoint Countries
ST3073+ST3074 DM09006 Phase I Dose range: 1.6-2.5 mg/kg/day DHA and 12.4-20.3 mg/kg/dayPQP 40 mg DHA/320 mg PQP tablet. 3 oral doses in 48 hrs. Placebo, Riamet,(AL), moxifloxacin 268 Adult healthy volunteers To evaluate the effect of multiple oral doses of DHA and PQPon the QT/QTc interval compared to AL, placebo andmoxifloxacin in healthy male and female volunteers France
ST3073+ST3074 DM09007 Phase I Dose range: 1.6-2.7 mg/kg/day DHA and 12.4-21.8 mg/kg/dayPQP 40 mg DHA/320 mg PQP tablet. 3 oral doses in 48 hrs. Not Applicable 72 Adult healthy volunteers DHA and PQP PK in healthy male and female Asian and Caucasianvolunteers after single and repeated dose of Eurartesim Australia
ST3073+ST3074 DM09008 Phase I Dose range: 1.7-2.1 mg/kg/day DHA and 13.9-17 mg/kg/dayPQP 40 mg DHA/320 mg PQP tablet. One single oral dose. Not Applicable 37 Adult healthy volunteers To assess the effect of food on the PK of DHA and PQP aftersingle oral administration of Eurartesim in healthy maleadult volunteers Australia
ST3073+ST3074 DM 04008 (Africa) Phase I/II Dose range: 1.67-3.08 mg/kg/day DHA and 13.3-24.64 mg/kg/dayPQP 20 mg DHA/160 mg PQP or 40 mg DHA/320 mg PQP tablet. 3 oraldoses in 48 hrs. Not Applicable 32 Paediatric P. falciparum malaria patients To assess the PK of DHA and PQP by analysing serial bloodsamples during and after a therapeutic course in childrenwith malaria Burkina Faso
ST3073+ST3074 DM04009 (Asia) Phase I/II Dose range: 1.6-3.64 mg/kg/day DHA and 12.8-29.12 mg/kg/dayPQP 40 mg DHA/320 mg PQP tablet. 3 oral doses in 48 hrs. Not Applicable 25 Adult P. falciparum malaria patients To assess the pharmacokinetics of DHA and PQP by analysingserial blood samples during and after a therapeutic coursein adults with malaria. Thailand
ST3073+ST3074 DM040010 (Asia) Phase III Dose range:1.67-3.33 mg/kg/day DHA and 13.3-26.7 mg/kg/dayPQP 20 mg DHA/160 mg PQP or 40 mg DHA/320 mg PQP tablet. 3 oraldoses in 48hrs. 50 mg AS + 250 mg MQ AS 4 mg/kg/day for 3 days + MQ 25 mg/kgdivided into two doses 1150 Adult and paediatric P. falciparum malariapatients (even in combination with other Plasmodia) To demonstrate that the PCR-corrected cure rate of DHA-PQP atDay 63 is non-inferior to that of AS+MQ (non-inferioritymargin=5%) Thailand, India, Laos
ST3073+ST3074 DM040011 (Africa) Phase III Dose range: 1.6-3.64 mg/kg/day DHA and 12.8-29.12 mg/kg/dayPQP 20mg DHA/160mg PQP or 40mg DHA/320 mg PQP tablet. 3 oraldoses in 48 hrs 20 mg A/120 mg L 2-6 tablets per day over 3 days dependant onbody weight 1553 Paediatric P. falciparum malaria patients To demonstrate that the PCR-corrected cure rate of DHA-PQP atDay 28 is non-inferior to that of AL (non-inferioritymargin=5%) Burkina faso, Kenya, Uganda, Mozambique, Zambia