This study is a first-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.~64 healthy male and female subjects are selected according to the inclusion and exclusion criteria, i.e., 50 subjects in Part 1 (SAD: 2 cohorts of 22 [Cohort A], 28 [Cohort B], respectively) and 14 subjects in Part 2 (MAD). The total duration of the study is 10 months.~All FR104 doses are administered intravenously by a slow infusion of at least 30 minutes. A staggered approach is observed within all dose levels. An interval of at least 14 days (last to first administration) is observed between all dose levels. Individual subjects on a same day of dosing are dosed at least 60 minutes apart.
First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.