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This is an open-label, multiple dose, PK and safety study in patients with chronic, stable schizophrenia or schizoaffective disorder.
Approximately 75 male and female patients with schizophrenia or schizoaffective disorder on antipsychotic maintenance medication will be enrolled into the study. There will be 4 planned cohorts of 14 patients per cohort.
In Cohorts 1-3, patients' planned participation in the study is for a total of approximately 22 weeks, including a Screening period of up to 35 days, and a study treatment period of 120 days (including follow-up).
In Cohort 4 planned participation in the study is for a total of approximately 18 weeks including a Screening period of up to 35 days and a study treatment of 92 days (including follow-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 60 mg of ZX003 administered 4 times (every 4 weeks) |
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| Cohort 2 | Experimental | 90 mg of ZX003 administered 4 times (every 4 weeks) |
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| Cohort 3 | Experimental | 120 mg of ZX003 administered 4 times (every 4 weeks) |
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| Cohort 4 | Active Comparator | Risperdal Consta administered 5 times (once every 2 weeks) NOTE: Oral risperidone 2 mg will be given with the first injection of Risperdal Consta and continued for 3 weeks (and then discontinued) to ensure adequate therapeutic plasma concentrations from Risperdal Consta. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZX003 (Risperidone-SABER®) | Drug | ZX003 administered as a SC injection |
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| Measure | Description | Time Frame |
|---|---|---|
| PK profile of ZX003 determined by C max, T max, C min, AUC (0-24h), AUC (0-tau), C avg | Day 1 through day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of ZX003 as measured by assessing adverse events. | Day 1 through day 120 | |
| Safety and tolerability of ZX003 as measured by assessing laboratory values. | Day 1 through day 120 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Walling, PhD | Collaborative Neuroscience Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network | Long Beach | California | 90806 | United States |
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| Risperdal Consta | Drug | Risperdal Consta administered as a IM injection |
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| Oral Risperidone | Drug | Oral Risperidone given to ensure adequate therapeutic plasma concentrations from Risperdal Consta |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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