Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia

Inclusion Criteria:

A patient will be eligible for inclusion in the study if they meet all of the following criteria:

1. Patient who is able to provide written informed consent (as required byInstitutional Review Board [IRB]) prior to the initiation of any protocol-requiredprocedures.

2. Must be willing to be hospitalized for the duration of the inpatient period of thestudy.

3. Have stable living environment when not in a hospital.

4. Male and female patients 18 to 55 years of age inclusive at the time of informedconsent with a diagnosis of schizophrenia as defined by DSM-5 criteria and confirmedby the MINI 7.0.2 .

5. Body mass index (BMI) must be ≥18 and ≤40 kg/m2.

6. Patient who experiencing an acute exacerbation of psychotic symptoms, AND thepatient requires hospitalization OR if already an inpatient at Screening, has beenhospitalized for onset < 2 weeks for the current exacerbation.

7. Patients who are experiencing an acute exacerbation of psychotic symptoms and markeddeterioration of usual function as demonstrated by meeting ALL of the followingcriteria at the Screening and Baseline visits:

• Total PANSS score between 80 and 120, inclusive, and

• Score of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P)items: Item 1 (P1; delusions), Item 2 (P2; conceptual disorganization), Item 3 (P3; hallucinatory behavior), Item 6 (P6; suspiciousness/persecution), and

• CGI-S score ≥4 (moderately to severely ill).

8. Have received previous antipsychotic treatment (dose and duration as per the label)and who showed a previous good response to such antipsychotic treatment (other thanclozapine) in the last 12 months, according to the Investigator's opinion.

9. Have history of relapse and/or exacerbation of symptoms when they were not receivingantipsychotic treatment.

10. Patients willing to discontinue all prohibited psychotropic medications prior toScreening, if determined to be clinically appropriate by the Investigator, and notfor the sole purpose of inclusion in the trial.

Exclusion Criteria:

A patient will be excluded from the study if they meet any of the following criteria:

Sex and Reproductive Status

1. Sexually active females of childbearing potential and male patients who are notpracticing 2 different methods of birth control with their partner during the trialand for 30 days after the last dose of trial medication or who would not remainabstinent during the trial and for 30 days after the last dose.

2. Females who are breastfeeding or who have a positive pregnancy test result prior toreceiving trial medication.

3. Patients who presented with a first episode of schizophrenia.

4. Improvement of ≥20% in total PANSS score between the Screening and Baselineassessments.

5. History of treatment resistance to schizophrenia medications defined as failure torespond to 2 adequate courses of pharmacotherapy (dose and duration as per thelabel) or required clozapine within the last 12 months.

6. Current DSM-5 Axis I diagnosis other than schizophrenia.

7. Risk for suicidal behavior during the study.

8. Risk of violent or destructive behavior.

9. Patients with clinically significant tardive dyskinesia.

10. Patients with a score of 3 on the Barnes Akathisia Rating Scale (BARS) globalclinical assessment of akathisia.

11. Patients who met DSM-5 criteria for substance abuse or dependence within the past 1year.

12. Patients with hypothyroidism or hyperthyroidism or clinically significant abnormalthyroid function.

13. History or presence of clinically significant cardiovascular, pulmonary, hepatic,renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, or oncologic disease or any other condition that, in the opinion of theInvestigator, would jeopardize the safety of the subject or the validity of thestudy results.

14. Patients with insulin-dependent diabetes mellitus (i.e., any patient using insulin)are excluded. Patients with non-insulin-dependent diabetes mellitus may be eligiblefor the trial if their condition is stable as determined by satisfying ALL of thefollowing criteria:

• Glycosylated hemoglobin (HbA1c) <7.0%, and

• Screening glucose must have been ≤125 mg/dL or ≤6.94 mmol/L (fasting) or <200mg/dL or <11.1 mmol/L (nonfasting), and

• Patient had been maintained on a stable regimen of oral antidiabeticmedication(s) for at least 28 days prior to Screening or diabetes had been wellcontrolled by diet for at least 28 days prior to Screening, and

• Patient had no hospitalizations within the 12 months prior to Screening due todiabetes or complications related to diabetes, and

• Patient's diabetes should not be newly diagnosed during Screening for thetrial.

15. Patients with uncontrolled hypertension or symptomatic hypotension, or orthostatichypotension

16. Patients with known ischemic heart disease or any history of myocardial infarction,congestive heart failure.

17. Patients with epilepsy or a history of seizures.

18. Patients with a positive urine drug screen or a positive blood alcohol test.

19. Patients with a history of alcohol use or substance use disorder (by DSM-5 criteria)within 12 months of Screening or a positive screen for drugs of abuse at Screening.

20. The following laboratory test results are exclusionary:

• Platelets ≤75,000/µL or ≤75×109/L

• Hemoglobin ≤9 g/dL or ≤90 g/L

• Neutrophils, absolute ≤1000/µL or ≤1×109/L

• AST and ALT >2 × upper limit of normal (ULN)

• CPK >3 × ULN, unless discussed with and approved by the Medical Monitor

• Creatinine ≥2 mg/dL or ≥176.8 µmol/L

• Estimated creatinine clearance of <45 mL/min, calculated using theCockcroft-Gault equation, at Screening

• HbA1c ≥7.0%

• Abnormal free T4 (during Screening), unless discussed with and approved by theMedical Monitor.

21. Clinically significant abnormal finding on the triplicate set of electrocardiograms (ECGs) or evidence of any of the following cardiac conduction abnormalities atScreening.

22. Patients who are currently taking oral antipsychotic medications, monoamine oxidaseinhibitors (MAOIs), anticonvulsants (e.g., lamotrigine, Depakote), tricyclicantidepressants (e.g., imipramine, desipramine), selective serotonin reuptakeinhibitors, and any other antidepressants or any other psychoactive medications (except lorazepam, zolpidem, zaleplon, eszopiclone, or similar benzodiazepines,diphenhydramine, benztropine, and propranolol). The medications should not bediscontinued solely to make the patient eligible for enrollment in the study.

23. Patients who received electroconvulsive therapy, or Transcranial MagneticStimulation (TMS).

24. Patients with a history of neuroleptic malignant syndrome.

25. Patients with a history of allergic response

26. Prisoners or patients who were compulsorily detained (involuntarily hospitalized)for treatment of either a psychiatric or physical illness or have been in the last 6months prior to the Screening Visit

27. Patients who have participated in another clinical study in which they received anexperimental or investigational drug agent within 3 months of Screening.