A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia

Inclusion Criteria

• 1. Subject has capacity; is willing and able to provide written consent for use and disclosure of protected health information per requirements of 45CFR164.508 (Health Insurance Portability and Accountability Act; HIPAA) prior to initiating any study procedure after being informed of the nature of the study, in the opinion of the study staff and PI.
• Subject is male or female 18 to 65 years of age, inclusive. 3. Subject has a diagnosis of schizophrenia as per DSM-IV-TR criteria, which in the opinion of the Investigator has been clinically stable for the past 6 months.
• Subject has a Body Mass Index (BMI) greater than or equal to 19.5 and less than or equal to 38 kg/m2.
• Subject does not have clinically relevant abnormal laboratory values per Investigator discretion.
• Subject does not have clinically relevant findings from vital signs measurements per Investigator discretion.
• Female subject is eligible to enter and participate in the study if she is of:

a. Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal);

• Postmenopausal females defined as being amenorrheic for greater than 2 years (or confirmed by FSH level) with an appropriate clinical profile.
• Women who have not been confirmed as postmenopausal should be advised to use contraception as outlined below.
• Women who have had a hysterectomy, bilateral oophorectomy or bilateral salpingectomy (as determined by subject's medical history).

b. Child-bearing potential (all females ≤ 65 years of age), has a negative pregnancy test at screening and agrees to satisfy one of the following requirements:

• Complete abstinence from intercourse (as part of an abstinent lifestyle) a minimum of 2 months prior to administration of the first dose of study drug, throughout the Treatment Period, and for a minimum of 3 months after completion or premature discontinuation from the study drug; or,
• Established use of highly effective methods of contraception from 1 month prior to administration of the first dose of study drug, during the Treatment Period, and 60 days after completion or premature discontinuation from the study drug.
• Because of the unacceptable failure rate of barrier (chemical and/or physical) methods, the barrier method of contraception must only be used in combination with a highly effective method. Post-coital methods of contraception are not permitted.
• Male subjects with partners of child bearing potential must be practicing abstinence, part of an abstinent life style or using protocol-specified methods of birth control throughout the study and for 30 days after completion or premature discontinuation from the study drug.
• Subject is able and willing to remain off of prior antipsychotic medication until the protocol-specified restabilization period.
• Subject has a stable living arrangement for at least 3 months prior to Day -12 and agrees to return to a similar living arrangement after discharge. Such subjects remain eligible to participate in this protocol with approval from the PI. Chronically homeless subjects should not be enrolled. The Medical Monitor should be consulted for individual cases as

Exclusion Criteria

• Subject had an acute exacerbation of psychiatric symptoms requiring change in antipsychotic medication (with reference to drug or dose) within 3 months (90 days) before screening.
• Subject has known or suspected carcinoma.
• Subject has known presence or history of renal or hepatic insufficiency.
• Subject has significant disease(s) or clinically significant finding(s) on physical examination determined by the Investigator to pose a health concern to the subject while on study.
• Subject has a history or presence of clinically significant abnormal ECG (based on ECG central overread report) that may jeopardize the subject's safety to participate in this study, or a screening 12-lead ECG demonstrating any one