Nulibry: how was the first human dose set?

“A total of 24 subjects was randomized into three sequential cohorts (6 active: 2 placebo) and received a single IV infusion of fosdenopterin at doses of 0.075, 0.25, and 0.68 mg/kg.”

“These findings were without histopathological correlates and were considered non-adverse. NOAELs for fosdenopterin were 5 mg/kg/day (rats) and 10 mg/kg/day (dogs), the highest dose levels evaluated.”