The study objectives were to evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of NG2-73 in healthy male and female subjects. Each cohort of subjects in the study received a higher dose of the drug than the preceding cohort with the objective of exploring a wide range of doses to define a maximum tolerated dose.
NG2-73 demonstrated a dose proportional increase in concentration in subjects’ blood samples with each cohort.
“We’re very pleased with the solid results of our single rising dose study,” said William Koster, president and CEO. Though not an endpoint of the trial, an apparent effect of the drug was that NG2-73 induced sleep in treated subjects, consistent with the results of our preclinical animal studies.”