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).
Phase:
Phase 2
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
Ranbaxy Laboratories Limited Swiss Tropical & Public Health Institute