The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics of Brexpiprazole Long-acting Injection Following a Single Administration in Healthy Subjects/Patients With Schizophrenia.

Inclusion Criteria:

Healthy Volunteers:

1. Male and female subjects aged 18 to 65 years (including) at the time of signing theinformed consent (the number of single sex in each group is not less than 1/4);

2. Body mass index (BMI) in the range of 19.0-26.0 (including the critical value), andfemale weight ≥ 45 kg, male weight ≥ 50 kg;

3. Subjects of childbearing potential (including partners) have no pregnancy plan orsperm donation and egg donation plan since signing the informed consent form towithin 1 year after the last dose of the investigational drug, and voluntarily takeeffective contraceptive measures;

4. Sign informed consent before the trial, and fully understand the trial content,process and possible adverse reactions;

5. Subjects can communicate well with the investigator, and understand and comply withthe requirements of this study.

Patients with schizophrenia:

1. Male and female subjects aged 18 to 65 years (including) at the time of signing theinformed consent (the number of single sex in each group is not less than 1/4);

2. Patients diagnosed with schizophrenia according to ICD-10, and the positive andnegative symptom scale (PANSS) score ≤ 70 points, and the investigator judged stabledisease within 4 weeks before screening;

3. Body mass index (BMI) ≥ 18.5 kg/m2 and < 35.0 kg/m2, and female weight ≥ 45 kg, maleweight ≥ 50 kg;

4. Subjects need to complete the tolerance test according to the protocol requirements;

5. Subjects of childbearing potential (including partners) have no pregnancy plan orsperm donation and egg donation plan since signing the informed consent form towithin 1 year after the last dose of the investigational drug, and voluntarily takeeffective contraceptive measures;

6. Subjects and their guardians signed informed consent;

7. Subjects and their guardians agree to comply with the protocol and cooperate withthe investigator to complete the trial.

Exclusion Criteria:

Healthy Volunteers:

1. History of cardiovascular system (such as history of ischemic heart disease),endocrine system, urinary system, nervous system, hematology, immunology (includingpersonal or family history of hereditary immunodeficiency), metabolic abnormalities,and the researchers believe that there is still clinical significance;

2. Physical examination, vital signs, 12-lead electrocardiogram, clinical laboratorytests (including hematology, urinalysis, serum biochemistry, thyroid panel,coagulation panel, serum prolactin, virological examination, lipid panel, serumpregnancy test (only women of childbearing age) and glycosylated hemoglobin, etc.),chest X-ray or CT and B-ultrasound with Injection site results in injection site areabnormal and clinically significant;;

3. Those who have taken any brexpiprazole preparation within 28 days prior to oraltolerance test drugs (brexpiprazole tablets);

4. Those who have been enrolled in clinical trials of brepiprazole long-actinginjection and have received the test drug administration;

5. Participate in any drug or medical device clinical trial and receive the treatmentof the investigational drug or medical device within 28 days before dosing (otherthan the drug/equipment used in this study), except for subjects participating inthe research or observational study;

6. Those who have used any drugs that interact with brepiprazole within 30 days beforeadministration [including CYP3A4 inducers and inhibitors, CYP2D6 inducers andinhibitors] (except topical preparations with local effects);

7. Those who have used any drugs within 14 days before administration [includingprescription drugs, over-the-counter drugs, traditional Chinese medicine, etc.] (except topical preparations with local effects);

8. Consumption of foods or beverages rich in xanthine (such as sardines, animal liver,etc.), grapefruit (such as grapefruit, western grapefruit, lime, carambola, etc.),caffeine (such as coffee, strong tea, cola, milk tea, etc.) within 48 hours beforedosing, or other special diet that can affect drug absorption, distribution,metabolism and excretion;

9. Those who drink excessive amounts (more than 8 cups, 1 cup = 250 mL) of tea orcoffee or beverages rich in xanthine/caffeine/grapefruit (such as milk tea, cola,fruit juice, etc.) before administration;

10. Previous alcohol abuse (i.e., men drink more than 28 standard units per week, womendrink more than 21 standard units per week (1 standard unit contains 14 g alcohol,such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or frequentalcohol consumption within the first 6 months before screening (more than 14standard units per week) and determined by the investigator to affect the test, orunwilling to stop drinking or any alcohol-containing products from the date ofscreening to the last PK blood collection period;

11. Those who smoke more than 3 cigarettes per day within 3 months before dosing, or areunwilling to stop using any tobacco products from the date of screening to the lastPK blood collection in the trial;

12. Those with a history of drug dependence or a history of drug abuse;

13. Positive urine drug abuse screening;

14. Alcohol breath test positive;

15. Those who donate blood or transfuse blood products or use blood products within 1month before administration (> 200 mL);

16. Those who have undergone surgery within 1 month before administration, or who planto undergo surgery from the date of screening to the last PK blood collection periodof the trial;

17. Those who are allergic or allergic to any component of this product and excipients (allergic to two or more drugs or food);

18. History of needle sickness or blood sickness with clinical significance judged bythe investigator to;

19. Pregnant or lactating women;

20. Those who have unprotected sex within 2 weeks prior to administration;

21. The investigator judged that it was not suitable to participate in this trial.

Patients with schizophrenia:

1. Patients with other psychiatric diseases other than schizophrenia diagnosedaccording to ICD-10 (except the diagnosis of concomitant symptoms of schizophrenia);

2. Participate in any drug or medical device clinical trial and receive the treatmentof the investigational drug or medical device within 28 days before dosing (otherthan the drug/equipment used in this study), except for subjects participating inthe research or observational study;

3. Those who have taken any brexpiprazole tablets for tolerance testing within 28 daysprior to oral tolerance test drugs (brexpiprazole tablets);

4. Those who have been enrolled in the clinical trial of brexpiprazole long-actinginjection and received the test drug administration;

5. More than 1 other antipsychotic drug was used before administration (except for thebrexpiprazole tablets given for tolerance testing, which can be combined with ≤ 1other antipsychotic drug and the drug has been treated at a stable dose for ≥ 14days before administration);

6. Those who have received other antipsychotic long-acting injection treatment and theinterval from the first dose is shorter than that of the long-acting injection;

7. Patients with clinically significant cardiovascular and cerebrovascular diseases,including but not limited to: Concomitant cardiac insufficiency, Severe arrhythmiasrequiring treatment, Ischemic heart disease requiring treatment, Previous or currentcongenital heart disease, Previous or present severe organic heart disease, Historyof stroke or transient ischemic attack within 1 year prior to screening, QTcinterval ≥ 450 ms in men or ≥ 470 ms in women, Orthostatic hypotension (decrease insystolic blood pressure (SBP) ≥ 20 mmHg or diastolic blood pressure (DBP) ≥ 10 mmHgwithin 3 minutes after changing from supine to upright position), Heart rate < 50bpm or > 100 bpm at rest, Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100mmHg);

8. Patients with poorly controlled diabetes (HbA1c ≥ 7.0%);

9. Pre-dose hematopoiesis and major organ function indicators meet any of the followingcriteria: White blood cell count < 3.0 × 109/L, neutrophil count < 1.5 × 109/L,platelet count < 75 × 109/L, red blood cell count < 3.0 × 1012/L, hemoglobin < 100g/L;Total bilirubin > 2 times the upper limit of normal, alanine aminotransferase > 2 times the upper limit of normal, and aspartate aminotransferase > 2 times theupper limit of normal;Creatinine > 1.5 times the upper limit of normal;Creatinekinase > 3 times the upper limit of normal;

10. Previous alcohol abuse (i.e., men drink more than 28 standard units per week, womendrink more than 21 standard units per week (1 standard unit contains 14 g alcohol,such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or frequentalcohol consumption within the first 6 months before screening (more than 14standard units per week) and determined by the investigator to affect the test, orunwilling to stop drinking or any alcohol-containing products from the date ofscreening to the last PK blood collection period;

11. Those who drink excessive amounts (more than 8 cups, 1 cup = 250 mL) of tea orcoffee or beverages rich in xanthine/caffeine/grapefruit (such as milk tea, cola,fruit juice, etc.) before administration;

12. Those who smoke more than 3 cigarettes per day within 3 months before dosing, or areunwilling to stop using any tobacco products from the date of screening to the lastPK blood collection in the trial;

13. Alcohol breath test positive;

14. Those with a history of drug dependence or a history of drug abuse;

15. Positive urine drug abuse screening;

16. Those who donate blood or transfuse blood products or use blood products within 1month before administration (> 200 mL);

17. Those who have undergone surgery within 1 month before dosing, or who plan toundergo surgery from the date of screening to the last PK blood collection period ofthe trial;

18. Patients with Parkinson's disease, malignant syndrome or dementia-related psychosis;

19. Previous or current tardive dyskinesia (the 8th item score of the involuntarymovement scale (AIMS) ≥ 3) or severe akathisia (BARS) overall clinical assessmentscore of 5 points;

20. Patients with epilepsy or convulsive diseases (except febrile convulsions);

21. Subjects with severe suicidal tendency: the fourth and fifth items of "suicidalideation" in the Columbia Suicide Severity Rating Scale (C-SSRS) answered "Yes" andthe most recent episode within 6 months met the criteria;Or any one of the "suicidalbehavior" in the C-SSRS answered "yes" and the most recent episode within 2 yearsmet any of the 5 items;Or, in the opinion of the investigator, the subject is atserious risk of suicide;

22. Have a history of needle sickness or blood sickness, and judged by the investigatorto have clinical significance;

23. Those who are allergic or allergic to any component of this product and excipients (allergic to two or more drugs or food);

24. Those who have received electroconvulsive therapy within 14 days prior to screening;

25. Positive for HBsAg, HCV-Ab, Anti-HIV, syphilis antibody;

26. Pregnant or lactating women;

27. Those who have unprotected sex within 2 weeks prior to dosing;

28. Those who have used the following drugs or food before administration: Received anyprescription of traditional Chinese medicine preparations, including traditionalChinese medicine, Chinese herbal decoction pieces, Chinese patent medicine, etc.,within 14 days (except topical preparations with local effects), Treatment withCYP3A4 or CYP2D6 inhibitors or inducers within 7 days or 5 drug half-lives,whichever is longer (except topical preparations with local effects), Consumption offoods or beverages rich in xanthine (e.g., sardines, animal liver, etc.), grapefruit (e.g., grapefruit, grapefruit, lime, carambola, etc.), caffeine (e.g. coffee, strongtea, cola, milk tea, etc.), or other special diet that can affect drug absorption,distribution, metabolism and excretion within 48 hours;

29. The investigator judged that it was not suitable to participate in this trial.