5 results
The primary objective of the study is to demonstrate non-inferiority of an insulin regimen using insulin glargine as the basal insulin with Exubera as the mealtime insulin, compared to a regimen using insulin glargine as the basal insulin and…
Primary objectiveTo determine the efficacy of chronic treatment with arimoclomol 1200 mg/day (400 mg TID) compared to placebo over 76 weeks in subjects with ALS as assessed with Combined Assessment of Function and Survival (CAFS).Secondary…
Primary Objectives:* To evaluate the effects of therapeutic and supratherapeutic plasma levels of arimoclomol on the heart rate-corrected QT interval (QTc).Secondary Objectives:* To evaluate the effect of arimoclomol on other ECG parameters: heart…
Primary objective:To assess the long-term safety of arimoclomol treatment of ALS.Secondary objective:To evaluate the long-term efficacy of arimoclomol treatment of ALS.Exploratory objectives:Health-related quality of life* To evaluate the effect of…
Phase 1• To establish the RP2D regimen by evaluation of the safety and tolerability of intravenous (IV) administration of Lutetium (177Lu) rhPSMA-10.1 injection in subjects with mCRPC.Phase 2• To evaluate the efficacy of Lutetium (177Lu) rhPSMA-10.1…