In 2016, a staggering 216 million people developed malaria, and 445,000 died—primarily children in sub-Saharan Africa. But a new first-in-human study sponsored by the National Institute of Allergy and Infectious Disease may help reduce the numbers of future victims.
Enrollment has begun in a phase I trial to test the safety of DM1157, an investigational modified form of chloroquine. Many strains of Plasmodium falciparum are now resistant to chloroquine. In fact, the parasites can expel the drug before it can affect them. Like chloroquine, DM1157 interferes with the parasite’s metabolism, but it also inhibits the parasite’s ability to expel the drug.
The study will enroll up to 104 healthy volunteers aged 18-45 years. One group will fast overnight and then receive either a single dose of the experimental drug at 1 of 7 dosage levels or a placebo. A second group also will fast and receive 1 dose at 1 of 4 dosage levels and repeat the routine for 2 more consecutive days. A third group will be given either a single 300-mg dose or placebo after eating a high-fat meal.
The study is expected to be completed by June 2019.