Phase 1 human clinical trials begin on antimalarial drug

The National Institute of Allergy and Infectious Diseases (NIAID), in conjunction with the Duke University School of Medicine, has begun enrolling for a Phase 1 clinical trial of a new antimalarial drug and its efficacy in humans.

This early stage trial is being led by Dr. Michael Cohen-Wolkowiez, professor of pediatrics at the Duke Clinical Research Institute. It utilizes a modified version of the drug chloroquine, an antimalarial drug that kills malaria parasites which have infected human red blood cells. Unfortunately, many strains of the most deadly form of malaria have grown resistant to chloroquine, so the new version interferes with the parasite’s metabolism and inhibits its ability to expel the drug. The drug is currently called DM1157.

Millions of malaria cases break out each year, especially in Africa, and increasing drug resistance is not helping. Thus, positive results of DM1157’s efficacy during animal testing have given hope for its usefulness among human cases. To test this, up to 104 healthy enrollees between the ages of 18 and 45 will be included in the study.

Volunteers will be split into three groups, who will be tested until approximately June 2019. One group will fast overnight and be given either a single dose of the experimental drug at one of seven dosage levels or a placebo. The second group will fast overnight and receive either a single dose at four specific dosage levels or a placebo. They will repeat that routine for two more days. The third and smallest group will either take a placebo or a single 300 mg dose of the drug, after eating a high-fat meal. That group will help scientists determine if food intake affects the drug. Volunteers will then be monitored and their blood sampled.