A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Inclusion Criteria:

1. Male or female subject between 18 to 65 years of age (inclusive) at the time ofconsent.

2. Subject must give written informed consent and privacy authorization prior toparticipation in the study; adolescents must also provide informed assent.

3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interviewat screeing.

4. Subject must have a CGI-S score ≥ 4

5. Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or moreof the following PANSS items: delusions, conceptual disorganization, hallucinations,and unusual thought content

6. Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2months prior to providing informed consent).

7. Subject has marked deterioration of functioning in one or more areas.

8. Subject is, in the opinion of the Investigator, generally healthy based on screeningmedical history, PE, neurological examination, vital signs, ECG and clinicallaboratory values.

Exclusion Criteria:

1. Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5diagnosis other than schizophrenia. Exclusionary disorders include but are notlimited to alcohol use disorder (within past 12 months), substance (other thannicotine or caffeine) use disorder within past 12 months, or lifetime history ofsignificant substance abuse that, in the opinion of the Investigator or Sponsor, mayhave had a significant and potentially permanent impact on the brain or other bodysystems, major depressive disorder, bipolar I or II disorder, schizoaffectivedisorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptomsof mild to moderate mood dysphoria or anxiety are allowed so long as these symptomsare not the primary focus of treatment.

2. Subject is at significant risk of harming self, others, or objects based onInvestigator's judgment.

3. Subject has any clinically significant unstable medical condition or any clinicallysignificant chronic disease that in the opinion of the Investigator, would limit thesubject's ability to complete and/or participate in the study

4. Female subject who is pregnant or lactating

5. Subject has any clinically significant abnormal laboratory value(s) at Screening asdetermined by investigator.