Schizophrenia Clinical Trial
Official title:
A Pilot, Open-Label, Non-Randomized, Single Ascending Dose, Safety and Pharmacokinetic Trial With Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Chronic, Stable Schizophrenia or Schizoaffective Disorder
This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.
This is an open-label, single ascending dose (SAD), safety and PK study in patients with chronic, stable schizophrenia or schizoaffective disorder. Patients will participate in the study for a total of up to 10 weeks for Cohorts 1-3, including a Screening period of up to 35 days and a study treatment period of 35 days, and up to 14 weeks for Cohort 4, including a Screening period of up to 35 days and a study treatment period of 63 days. Patients will be assigned to one of four cohorts, and will receive a single dose of 25 mg, 50 mg or 100 mg (100 mg/mL concentration) administered as a single subcutaneous (SC) injection or via the DosePro Needle-Free Delivery System. ;
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