The primary objectives of this Phase Ia study were to characterize the safety, tolerability and pharmacokinetics of a single dose of IL-29 administered subcutaneously. A total of 20 subjects were treated with IL-29 at dose levels up to 7.5mcg/kg (n=17) or placebo (n=3). Administration of a single dose of IL-29 was associated with dose-related pharmacokinetic and pharmacodynamic effects and was well tolerated at biologically active doses.
Evidence of biological activity, including up-regulation of interferon response markers, was seen starting at doses of 1.5mcg/kg. These results suggest that antiviral activity against hepatitis C virus might also be seen at these dose levels.
Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, said: “Results from this single dose Phase Ia study in healthy volunteers support moving forward into a repeat dose Phase Ib study in patients with hepatitis C. The biologically active dose levels observed in the Phase Ia study have been used to design a Phase Ib study to evaluate the safety and antiviral effects of repeat dosing in patients with relapsed hepatitis C infection.”