This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of approximately 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of approximately 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for a total duration of approximately 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in fed and fasted states to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms (ECGs), blood and urine lab analyses and occurrence of adverse events (AEs).
This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in a fed or fasted state to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days.