The study was a randomized, double-blind, placebo-controlled, cross-over, single-rising dose study conducted with healthy male volunteers. Objectives of the study included assessments of the safety, tolerability, and pharmacokinetics of CER-002 when administered as a single dose, as well as the effect of food on single dose pharmacokinetics. Twenty-four subjects received CER-002. The product was found to be well tolerated and safe at all doses tested, without any serious adverse effects.
Jean-Louis Dasseux, president and CEO of Cerenis, said: “CER-002 is a novel compound which has shown significant antiatherosclerotic properties in animal models even at low doses. As we move forward with the clinical development program for CER-002, we will also continue planning clinical stage development programs for the other promising product candidates in our portfolio.”