Pharmacokinetic and Safety Study of LY03004 in Stable Patients With Schizophrenia or Schizoaffective Disorder

Inclusion Criteria:

1. Male or female patients aged 18 to 65 years old;

2. Patients must have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder
based on the Mini-International Neuropsychiatric Interview (MINI);

3. Patients must be clinically stable on antipsychotic medications other than
risperidone or paliperidone or clozapine for at least 4 weeks prior to screening,
based on clinical assessments and a Positive and Negative Syndrome Scale (PANSS)
total score less than or equal to 70 at screening visit;

4. Patients with a Body Mass Index in range of 18.0 to 35.0;

5. Patients with an Informed consent form signed by the patient or legally acceptable
representative

Exclusion Criteria:

1. Patients with a mental disorders other than schizophrenia or schizoaffective
disorder, according to the DSM-IV;

2. Patients who received oral risperidone or paliperidone or clozapine within 14 days
prior to screening, or Risperdal Consta within 100 days prior to screening or
paliperidone palmitate within 10 months prior to screening;

3. Patients with neuroleptic malignant syndrome or physical fatigue associated with
dehydration or malnutrition;

4. Patients who pose a significant risk of a suicide attempt based on history,
investigator's judgment or have answered "yes" on the questions 4 or 5 for current or
past 30 days on the screening form of the Columbia Suicide Severity Rating Scale
(C-SSRS).

5. Patients with a history of sensitivity to akathisia and other EPS, especially with
previous use of risperidone or paliperidone.

6. Patients with uncontrolled diabetes mellitus as indicated by a HbA1c level greater
than or equal to 7%;

7. Patients with a history of or currently having epilepsy or convulsion disorders;

8. Patients who have had electroconvulsive therapy within the past 2 months prior to
screening;

9. Patients who used medication known to be an inducer or inhibitor for CYP 2D6 less
than 2 weeks prior to screening;

10. Patients with a history of allergic reaction to risperidone or to the excipients of
LY03004;

11. Patients who have met DSM-IV-TR criteria for substance abuse or dependence with the
exception of caffeine or nicotine in the past 6 months prior to screening

12. Patients with a history of clinically relevant cardiac arrhythmia's, cardiovascular
disease, thyrotoxicosis, parkinsonism, or hemorrhagic diathesis;

13. Patients who are currently taking medications with primarily CNS activities such as
antidepressants, mood stabilizers or anticonvulsants;

14. Patients who have participated in a clinical trial of another investigational drug
within 30 days prior to screening;

15. Female patients who are pregnant or are breastfeeding or are of childbearing
potential without adequate contraception.

16. Patients who have any clinically relevant hepatic, renal and cardiac dysfunction, or
other medical condition or laboratory abnormality, which in the judgment of the
investigator would interfere with the subject's ability to participate in the study