AtheroNova Inc. announced today a significant milestone in completing the active treatment portion of its Phase 1 clinical trial with its lead compound, AHRO-001. The objective of the Phase I study is to evaluate AHRO-001’s safety, tolerability, and pharmacokinetics in volunteers who are healthy. This clinical study is being conducted in Russia with AtheroNova's licensing partner, OOO CardioNova.
The design of the Phase 1 study is to characterize the safety of AHRO-001 through three dose ranges and possible pharmacokinetics, with a planned enrollment of 54 subjects. This multi-center, randomized, double-blind, placebo-controlled, single and multiple dose escalation, is the first-in-human study of AHRO-001 administered via oral tablet to healthy adult volunteers at sites in Moscow and St. Petersburg, Russia. All subjects have been dosed and received either placebo or AHRO-001 in doses ranging from 18.75 mg/kg to 37.5 mg/kg per day. Top line data is expected to be announced in the first quarter of 2014.