RBx11160 Phase II Dose Ranging Study RBx/MMV05-06
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial will identify the best dose of the synthetic peroxide RBx11160 to treat
      uncomplicated malaria. Patients will be treated over 7 days with daily doses of 50, 100 or
      200 mg RBx11160.

      The study is designed to assess the antimalarial activity and safety of 3 dose levels of RBx
      11160 administered once daily for 7 consecutive days. The primary endpoint will be the time
      to 90% parasite clearance. In future regulatory studies, RBx 11160 is likely to be
      administered in combination with another antimalarial agent since the development plan
      follows the current recommendation of WHO for the treatment of uncomplicated malaria.
      However, it is critical to gather data on RBx 11160 when used as monotherapy in adult
      patients suffering from acute uncomplicated P. falciparum malaria. In malaria-endemic
      regions, an adult population is defined on the basis of immune status rather than the legal
      age of consent. Thus, patients as young as 13 years of age can be enrolled provided consent
      has been obtained from a legal guardian in accordance with local practices and regulations.
      This study will be conducted in compliance with International Conference on Harmonization
      (ICH) Good Clinical Practice (GCP).
    

Detailed description: 
      This is a Phase II, double-blind, multicenter, randomized, parallel-group, dose-ranging study
      of the antimalarial activity and safety of 3 (50, 100, and 200 mg) RBx 11160 dose levels
      administered as a single dose orally for 7 consecutive days in patients with acute
      uncomplicated P. falciparum malaria (mono-infection).

      At least 255 patients will be randomized at 4 study sites in South East Asia, India and
      Africa. Each investigational site will enroll between 60 and 90 patients to yield
      approximately 65 "per protocol" patients in each treatment arm . Patients will be randomized
      to 1 of 3 dose groups. Patients will be administered RBx 11160 with matching placebo tablets
      as required to maintain the study blind.

      The study is divided into 3 main periods including the Pre-Treatment Period (Screening/Day
      0), the Treatment Period (Days 0 through 6; Day 0 is the first day of study medication
      dosing), and the Post-Treatment Period (Day 14 +/- 1 day; Day 21 +/- 1 day; and Day 28 +/- 2
      days).

      Patient participation will be for at least 28 (± 2) days following the first dose of study
      medication. Patients will be hospitalized for at least 4 days (Days 0, 1, 2, and 3), but may
      remain in the hospital or live in the vicinity of the study site for the study duration. If a
      patient is discharged from the hospital on Day 3, he/she will return to the study site or an
      authorized study staff member will visit the patient on Days 4 and 5 to administer study
      medication and perform indicated assessments. The patient will return to the study site for
      study visits on Days 6 (last dose of study medication administration), 14, 21, and 28.

      If adverse events reported during the study are unresolved by Day 28, patients will be
      followed for an additional 30 days or until resolution of the event or determination that no
      further medical management is deemed necessary. Similarly, the investigator will instruct the
      patient to return to the study site if any untoward event occurs within 30 days of completing
      study medication.
    

Intervention name(s): Treatment with 3 dose groups of RBx11160 over 7 days
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: malaria, falciparum; uncomplicated Plasmodium falciparum malaria