DesignMedix has started patient enrolment in a Phase l clinical trial to evaluate the safety of its investigational drug DM1157 to treat malaria and its effect on the human body.
The randomised, double-blind, placebo-controlled trial intends to include up to 104 healthy subjects between the age group of 18 and 45 years.
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During the course of the trial, the subjects will be randomly assigned to one of the three groups, the first of which will have 56 participants who will receive either a single dose of DM1157 at one of seven dosage levels (9mg to 900mg) or a placebo.
The second group will include 40 subjects to be treated with either one dose containing 150mg, 300mg, 600mg, or 900mg of DM1157, or a placebo.
In the third group, eight participants will be included and will receive either a single 300mg dose of DM1157 or placebo.
Subjects in each of the groups will provide blood samples for at least five days after their last dose during the trial, which is scheduled to be concluded by June next year.
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By GlobalDataDesignMedix will monitor the subjects in each of the groups for adverse effects.
Sponsored by the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID), the trial is currently going on at the Duke University School of Medicine in Durham, North Carolina, US.
Duke Clinical Research Institute paediatrics professor Michael Cohen-Wolkowiez is the principal investigator of the Phase l trial.
NIAID director Anthony Fauci said: “The increasing problem of drug resistance demands that we continue to find new and effective treatment options for malaria infection.”
According to the World Health Organization (WHO), around 216 million new malaria cases were detected and 445,000 deaths occurred in 2016, primarily among children living in sub-Saharan Africa.
