5 results
Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…
The primary objectives of this study are as follows:* To assess the safety and tolerability of escalating single and multiple doses of GS-5745 in subjects with moderate to severe ulcerativecolitis (UC) as assessed by adverse events (AEs), and…
Primary ObjectivePart1: To evaluate the safety and tolerability of intravenous (IV) administration of AL001 over up to 96 weeks in asymptomatic and symptomatic carriersof a granulin (GRN) mutation causative of frontotemporal dementia (FTD) and in…
The primary objective of this study is: Part 1: To evaluate the efficacy of AL001 compared with placebo as measured by CDR® plus NACC FTLD-SB.Part 2: To assess the long-term safety and tolerability of AL001 in participants who have completed 96…
The primary objective of this study is to determine the safety and feasibility of turbine-based insufflation, measured in terms of occurrence of adverse device effects and serious adverse device effects. The secondary objectives are to determine the…