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:

• Patient who is able to provide written informed consent (as required by Institutional Review Board [IRB]) prior to the initiation of any protocol-required procedures.
• Must be willing to be hospitalized for the duration of the inpatient period of the study.
• Have stable living environment when not in a hospital.
• Male and female patients 18 to 55 years of age inclusive at the time of informed consent with a diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by the MINI 7.0.2 .
• Body mass index (BMI) must be ≥18 and ≤40 kg/m2.
• Patient who experiencing an acute exacerbation of psychotic symptoms, AND the patient requires hospitalization OR if already an inpatient at Screening, has been hospitalized for onset 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 the Cockcroft-Gault equation, at Screening
• HbA1c ≥7.0%
• Abnormal free T4 (during Screening), unless discussed with and approved by the Medical Monitor.
• Clinically significant abnormal finding on the triplicate set of electrocardiograms (ECGs) or evidence of any of the following cardiac conduction abnormalities at Screening.
• Patients who are currently taking oral antipsychotic medications, monoamine oxidase inhibitors (MAOIs), anticonvulsants (e.g., lamotrigine, Depakote), tricyclic antidepressants (e.g., imipramine, desipramine), selective serotonin reuptake inhibitors, 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 be discontinued solely to make the patient eligible for enrollment in the study.
• Patients who received electroconvulsive therapy, or Transcranial Magnetic Stimulation (TMS).
• Patients with a history of neuroleptic malignant syndrome.
• Patients with a history of allergic response
• Prisoners or patients who were compulsorily detained (involuntarily hospitalized) for treatment of either a psychiatric or physical illness or have been in the last 6 months prior to the Screening Visit
• Patients who have participated in another clinical study in which they received an experimental or investigational drug agent within 3 months of Screening.

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