NCT01592110

A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	risperidone-SABER	25 mg of risperidone-SABER administered as a subcutaneous (SC) injection of 0.25 mL
OTHER	ZX003:risperidone-SABER and the DosePro System	50 mg risperidone-SABER administered as 0.5 mL via the DosePro Needle-Free Injection System
DRUG	risperidone-SABER	50 mg of risperidone-SABER administered as a SC injection of 0.5 mL
DRUG	Risperidone-SABER	100 mg of risperidone-SABER administered as a SC injection of 1.0 mL

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-05-07
• Last updated: 2022-11-10

Locations

1 site across 1 country: United States