Single Ascending Dose Study of RBP-7000

This was an open-label, single-center, Phase 1, single ascending dose study, designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of a single SC injection of low, medium and high doses of RBP-7000 in subjects with clinically stable schizophrenia who were not taking risperidone. The design was a sequential cohort with treatment initiated in 3 cohorts after safety and tolerability at a lower dose were confirmed. Eligible subjects received a single oral test dose of 0.25mg risperidone under medical supervision. Subjects who continued to be eligible were admitted to a residential unit for approximately 14 days, and received a single dose of RBP-7000. Subjects were discharged on Day 15 and returned to the clinical site weekly for approximately 10 weeks.