The Phase I trial for AQX-1125 is a three-part, double-blinded, placebo-controlled, single ascending dose, multiple ascending dose and food effects study in healthy volunteers. The primary objectives of this Phase I are to evaluate the safety, tolerability and pharmacokinetics of AQX-1125 administered orally once-daily. A secondary objective includes investigating the pharmacodynamics of AQX-1125 through the utilization of biomarkers.
"The initiation of this study is an important milestone for the company," said David J. Main, Chairman, President and Chief Executive Officer of Aquinox Pharmaceuticals. "AQX-1125 has demonstrated promising efficacy in preclinical models of inflammatory disease and has desirable pharmaceutical properties making it a strong development candidate."
"The Phase I study will enroll 52 normal health volunteers at a single center in Europe," said David Chernoff, M.D., Chief Medical Officer of Aquinox. "We believe this study will provide us with the data necessary to progress our clinical programs forward into multiple proof-of-concept studies in different indications."