The Phase I double-blind, placebo-controlled trial has enrolled 30 healthy male and female subjects in sequential, dose-escalating cohorts. Subjects received once-daily subcutaneous injections of placebo or 40mg, 70mg or 100mg of tezampanel for four consecutive days, approximating exposure under steady-state pharmacokinetic conditions. Overall, tezampanel was well-tolerated. There were no dose-limiting adverse events or discontinuations from the study and reported adverse events were generally mild and transient.
Neil Kurtz, president and CEO of TorreyPines, said: “This study is an important step forward in the clinical development of tezampanel. Our ability to safely deliver multiple doses of tezampanel means that we can now pursue virtually any indication that requires chronic dosing.”