Schizophrenia Clinical Trial
Official title:
A Phase I, Open Label, Single Center, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetic Profile of RBP-7000 at Low, Medium, and High Doses
The purpose of this study was to assess the safety and tolerability of injections of RBP-7000 in subjects with stable schizophrenia
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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