Clinical trial NCT03627195
Conditions: Schizophrenia
Keywords: Schizophrenia
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2018-06-07; Completion date: 2019-03-29
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to determine the maximum tolerated dose of an investigational drug in subjects with schizophrenia

Detailed description:
This is a single-center, randomized, double-blind, placebo-controlled, inpatient, single ascending dose (SAD) study designed to evaluate the safety, tolerability, and PK of lurasidone injectable suspension in subjects with schizophrenia. This study will determine the minimum intolerable dose (MID), the maximum tolerated dose (MTD) of lurasidone injectable suspension, and characterize the PK profiles of lurasidone and its metabolites in serum (ID-14283, ID-14326, ID-11614, ID-20219, and ID-20220) and urine (ID-14283, ID-14326, and ID-11614) in this subject population. The potential effects of gender on the PK of lurasidone injectable suspension and its metabolites will also be evaluated when applicable.

Arms: arm 1: Lurasidone injection suspension (30 mg, 75 mg, 150 mg, 300 mg, and 450 mg) arm 2: placebo injection
Interventions: intervention 1: DSP-1349M intervention 2: placebo
Intervention descriptions: intervention 1: DSP-1349M injectable intervention 2: placebo injection

Protocol documents:
Prot_000.pdf: 
Titlpage
 
 
 
 
Lurasidone Injectable Suspension 
DSP-1349M 
Clinical Study Protocol D1052024 
 
A Randomized, Double Blind, Placebo Controlled, Single 
Ascending Dose Study with Lurasidone Injectable Suspension to 
Evaluate Safety, Tolerability, and Pharmacokinetics in Subjects 
with Schizophrenia 
 
IND No. 138,253 
 
Version 2.00 
13 June 2018 
 
 
SUNOVION PHARMACEUTICALS INC. 
84 Waterford Drive 
Marlborough, MA 01752, USA 
(508) 481-6700 
 


Protocol D1052024, Version 2.00 
 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
2 
 
13 June 2018 
RESTRICTED DISTRIBUTION OF PROTOCOLS 
This document contains information confidential and/or of proprietary interest to Sumitomo 
Dainippon Pharma Co., Ltd. and/or Sunovion Pharmaceuticals Inc. (including their 
The information cannot be disclosed to any third party or 
predecessors, subsidiaries or affiliates). 
used for any purpose other than the purpose for which it is being submitted without the prior 
written consent of the appropriate Sumitomo Dainippon Pharma company. 
This information is being provided to you for the purpose of conducting a clinical study for 
Sunovion Pharmaceuticals Inc. You may disclose the contents of this protocol to the study 
personnel under your supervision and to your Institutional Review Board or Independent Ethics 
Committee for the above purpose. You may not disclose the contents of this protocol to any 
other parties, unless such disclosure is required by government regulations or laws, without the 
prior written permission of Sunovion Pharmaceuticals Inc. 
Any data gathered during the conduct of this protocol and supplemental information (eg, a 
 
protocol amendment) that may be added to this document is also proprietary to Sunovion 
Pharmaceuticals Inc., and should be handled consistently with that stated above. 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
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13 June 2018 
EMERGENCY CONTACTS 
Table 1: Emergency Contact Information 
Role in Study 
Name 
Contact Information 
Responsible Physician 
 
Sunovion Pharmaceuticals 
Inc. 
Telephone: 
Email:  
Medical Advisor 
IQVIA 
Telephone:  
Email: 
 
24-Hour Serious Adverse 
Event/Pregnancy Reporting in 
the United States 
PPD Pharmacovigilance 
(PVG) 
Hotline Number: 
 Email: 
United States 
Fax:
 
Outside United States 
Fax: 
1 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
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13 June 2018 
1.
SYNOPSIS
Name of Sponsor: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone injectable suspension 
Name of Active Ingredient: Lurasidone (DSP-1349M) 
Proposed Indication: Schizophrenia 
Title of Study: A Randomized, Double Blind, Placebo Controlled, Single Ascending Dose Study with 
Lurasidone Injectable Suspension to Evaluate Safety, Tolerability, and Pharmacokinetics in Subjects 
with Schizophrenia 
Study Centers: 1 site in the United States 
Study Objectives: 
Safety Objective 
•
To assess safety, tolerability, and pharmacokinetics (PK) of a single dose of lurasidone
injectable suspension in subjects with schizophrenia.
Pharmacokinetic and Pharmacodynamic Objectives 
•
To assess the PK for the metabolites of lurasidone in serum (ID-14283, ID-14326,
ID-11614, ID-20219 and ID-20220) and in urine (ID-14283, ID-14326, and ID-11614) after
a single dose of lurasidone injectable suspension.
•
To assess Positive and Negative Syndrome Scale (PANSS) in subjects with schizophrenia
after a single dose of lurasidone injectable suspension.
Study Design 
This is a single-center, randomized, double-blind, placebo-controlled, inpatient, single ascending dose 
(SAD) study designed to evaluate the safety, tolerability, and PK of lurasidone injectable suspension in 
subjects with schizophrenia. This study will determine the minimum intolerable dose (MID), the 
maximum tolerated dose (MTD) of lurasidone injectable suspension, and characterize the PK profiles of 
lurasidone and its metabolites in serum (ID-14283, ID-14326, ID-11614, ID-20219, and ID-20220) and 
urine (ID-14283, ID-14326, and ID-11614) in this subject population. The potential effects of gender on 
the PK of lurasidone injectable suspension and its metabolites will also be evaluated when applicable. 
The study is planned to include up to 5 cohorts. A total of 8 subjects (6 active and 2 placebo) will be 
dosed in each cohort. Lurasidone injectable suspension dosing will be initiated at 30 mg given as an 
intramuscular (IM) injection at the ventrogluteal site. Subsequent cohorts are planned to be dosed at 75, 
150, 300, and 450 mg IM at the ventrogluteal site. Dose strengths after the first dose level may be 
modified based on safety assessments and exposure to lurasidone injectable suspension. 
All 5 planned dose cohorts may not be used, depending on the dose escalation strategy employed. 
Additional cohorts may be included in this study, as necessary, and determined following a review of 
safety and exposure of lurasidone injectable suspension. Planned dose levels may be modified or 
repeated based on the overall safety profile of the current and/or previous cohorts. 
A study schematic is provided below; the schedule of study procedures and assessments is provided in 
Table 2. 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
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Name of Sponsor: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone injectable suspension 
Name of Active Ingredient: Lurasidone (DSP-1349M) 
Study Schematic 
a Eligible subjects must be washed out/tapered off of their current antipsychotic medications 5 to 6 half-lives prior 
to Day -8 (may begin as early as Day -19). Subjects are required to be inpatient from Day -12 to Day 15 (for 
treatment and observation) and Day 29 to Day 33 (for restabilization to previous medications). Subjects may 
remain inpatient up to Day 33 (at the Investigator’s discretion). 
b Subjects will receive 2 oral lurasidone 80 mg doses (Days -7 and -6) and be assessed for safety and tolerability 
for 5 days (Days -5 to -1) and to allow appropriate time to washout of the oral lurasidone dose. 
c Randomization occurs on Day 1. Cohort 1 will receive a single lurasidone injectable suspension dose of 30 mg or 
a single placebo injection dose; thereafter, single lurasidone injectable suspension doses of 75, 150, 300, and 
450 mg may be administered (cohorts 2-5). 
d Subjects will be monitored for safety after the single lurasidone injectable suspension or placebo injection dose 
until Day 29. Subjects may be discharged on Day 15 at the Investigator’s discretion. 
e Subjects will restart prior medications (including antipsychotics) on Day 29 under observation of clinical site 
staff. 
Subjects with schizophrenia who provide informed consent to participate in the study will undergo 
screening procedures and assessments between Days -35 to -13 to determine study eligibility. 
Eligible subjects will be washed out/tapered off of their current antipsychotic medications over 
5 to 6 half-lives prior to Day -8 (may begin Day -19). Subjects will be monitored for safety during 
tapering/washout. Subjects will be admitted to the clinical site on Day -12 and are required to be 
inpatient until Day 15. 
Subjects will receive oral lurasidone 80 mg tablets on Day -7 and Day -6 (one dose per day), and be 
monitored for 5 days to ensure the subject is able to tolerate lurasidone (ie, absence of moderate adverse 
events). Subjects who tolerate dosing with oral lurasidone 80 mg will be eligible for randomization to 
receive a single lurasidone injectable suspension or placebo injection on Day 1. 
For Cohort 1, a sentinel group of 2 subjects will be dosed in a 1:1 ratio (lurasidone injectable 
suspension: placebo injection). A 7-day clinical assessment of safety and tolerability (including AEs, 
vital signs, and other clinically relevant findings) for the sentinel subjects will be made by the 
Investigator (ie, Day 2 to Day 8). The remaining subjects will be randomized in a 5:1 ratio (lurasidone 
injectable suspension: placebo injection). A sentinel group may not be required for future dose cohorts: 
absence of an immune response will obviate the need for sentinel dosing after Cohort 1. 
Subjects who are discharged after Day 15 will check into the clinical site again on Days 22 and 29 for 
scheduled assessments. Subjects will follow protocol procedures to remain in-clinic through Day 33 as 
they restart their prior medications (including antipsychotics), under observation of the 
Investigator/clinical site staff (ie, restabilization period). 
Subjects who remained in-clinic through Day 29 will remain inpatient through Day 33 as they restart 
their prior medications (including antipsychotics) under observation of the Investigator/clinical site staff 


Protocol D1052024, Version 2.00 
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Name of Sponsor: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone injectable suspension 
Name of Active Ingredient: Lurasidone (DSP-1349M) 
(ie, restabilization period). 
The restabilization period may be longer and subjects may remain in-clinic, as deemed necessary by the 
Investigator. 
Subjects who discontinue the study prior to Day 29 will undergo assessments scheduled for Day 29 at 
the time of discontinuation (see Table 2). Subjects who discontinue the study after Day 29 but prior to 
Day 61 will undergo assessments scheduled for Day 61 at the time of discontinuation (see Table 2). 
Subjects who complete the study per protocol will return to the clinic for a follow-up safety assessment 
on Day 61 (± 2). 
Dose Escalation/Safety Cohort Review 
After each cohort, a review of safety data (eg, AE [including potential psychotic symptoms and 
behavior], vital signs, laboratory data, standard 12-lead ECG, etc.) and lurasidone injectable suspension 
exposure data for all subjects (or at least 5 lurasidone and 1 placebo subjects completed) in each cohort 
will be performed. Subsequent dosing at the next dose level/cohort will not occur until safety and 
exposure data (from at least 14 days after the single lurasidone injectable suspension dose) have been 
evaluated by the Safety Review Team (SRT). The SRT consists of the PI, the Sponsor's Responsible 
Physician or designee, the Sponsor’s Project Medical Lead, the Sponsor’s Head of Translational 
Medicine and Early Development team or designee and the Medical Monitor. The SRT will also 
determine if sentinel subject dosing is required for study cohorts after Cohort 1. 
The decision to proceed to the next dose level/cohort and at what dose level will also be made by the 
voting members of the SRT, based on a review of the clinical observations, laboratory data, and 
exposure data, and will require a majority agreement concerning acceptable safety and tolerability of 
lurasidone injectable suspension. Based on these safety reviews, a more conservative dose escalation 
may be used that will be less than the planned dose escalation, or subsequent cohorts may repeat a dose 
level or de-escalate. For each cohort, the SRT will monitor and review AE and exposure data 14 days 
and 28 days after the injection dose. 
Treatment assignments for a particular cohort may be unblinded during a safety review meeting, but 
only after a blinded review of the safety data has been completed. PK exposure data will be utilized in 
the safety review; thus, it will be necessary for the bioanalytical laboratory to be unblinded to treatment 
assignment for the subjects. 
Determination of the Minimum Intolerable Dose (MID) and Maximum Tolerated Dose (MTD) 
The MID will be defined as the dose of Lurasidone injectable suspension at which dose limiting toxicity 
(DLT) occurs. Dose-limiting toxicity is indicated by the occurrence of intolerable AEs, which are not 
fully defined a priori, but will be determined from the study data at the SRT meetings. Adverse events, 
including SAEs, which start prior to the study drug injection, will not be considered for stopping criteria. 
Dose stopping criteria are provided in Section 9.3. 
Once a safety stopping criterion is reached, the study will be terminated at that dose level. If none of the 
stopping criteria has been attained, the study will proceed to the next higher dose level. Dosing of an 
additional cohort or cohorts at a dose between the identified MID and the highest dose below the MID 
may be conducted. The highest tolerated dose below the MID will be defined as the MTD for a single 
lurasidone injectable suspension dose. 
If the MTD is not established, additional dose cohorts may be commenced until the MTD is reached. 
Safety, Pharmacokinetic, and Pharmacodynamic Assessments 
Safety will be assessed throughout the study by monitoring AE (including injection site reactions), 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
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Name of Sponsor: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone injectable suspension 
Name of Active Ingredient: Lurasidone (DSP-1349M) 
physical examinations, vital signs (pulse rate, respiration rate, and body temperature), clinical laboratory 
tests (hematology, serum chemistry, urinalysis, lipid panel, coagulation panel, and thyroid panel), 
standard 12-lead ECGs, and the Columbia-Suicide Severity Rating Scale (C-SSRS). 
Blood samples will be collected for serum PK profiling of lurasidone and its metabolites in serum 
(ID-14283, ID-14326, ID-11614, ID-20219 and ID-20220) and urine (ID-14283, ID-14326, and 
ID-11614) in this subject population after injection dosing at the timepoints specified in the Schedule of 
Assessments (see Table 2). Serum and urine samples collected for PK assessment may also be used for 
the additional characterization and/or bioanalytical method development of putative metabolites of 
lurasidone and for biomarker measurement. 
The pharmacodynamic impact of lurasidone injectable suspension will be assessed using the Positive 
and Negative Schizophrenia Symptoms Scale (PANSS). 
Number of Subjects (planned): 
Approximately 8 subjects will be randomized per cohort for a total of up to 40 subjects and up to 
5 cohorts. 
Alternate subjects may be admitted to the clinical site in order to ensure that 8 subjects are dosed in each 
cohort. Subjects who are randomized but not dosed will be replaced by the alternate subject(s). 
Once 8 subjects per cohort are dosed, alternate subjects who are not needed to complete enrollment of a 
cohort will be discharged following reintroduction of their prior medication if they are clinically stable 
(in the Investigator’s opinion). 
Main Diagnosis and Criteria for Enrollment 
Adult male and female subjects 18 to 65 years of age, inclusive with a diagnosis of schizophrenia as per 
DSM-IV-TR criteria, which in the opinion of the Investigator has been clinically stable for the 6 months 
prior to Screening. Subjects must also be able and willing to remain off of prior antipsychotic 
medication until the protocol-specified restabilization period. Subjects must also have a stable living 
arrangement for at least 3 months prior to Study Day -12 and agree to return to a similar living 
arrangement after clinic discharge. Chronically homeless subjects should not be enrolled. The Medical 
Monitor should be consulted for individual cases as needed. 
Subjects will not be eligible if they have a known history of severe reaction to a previous antipsychotic 
(in the Investigator’s opinion) including up to 80 mg/day of oral lurasidone, or a history of drug-
dependence (per DSM-IV-TR) criteria during the 6-month period prior to Screening, or if they answer 
“yes” to “Suicidal Ideation” Items 4 or 5 on the C-SSRS at Screening or at any point prior to 
randomization or history of suicidal behavior within the last two years. Subjects will not be eligible if 
they have 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. 
The complete listing of study eligibility criteria is provided in Section 7. 
Investigational Product, Dosage and Mode of Administration 
Lurasidone injectable suspension will be provided as sterile white to off-white aqueous suspension 
(150 mg/mL lurasidone) for intramuscular injection. The suspension will be packaged in clear USP 
Type I glass vials with rubber stoppers. 
A starting dose of 30 mg (0.2 mL lurasidone injectable suspension) will be given. Lurasidone injectable 
suspension will be administered to subjects using syringe and gauge 22-23 needle. The syringe will be 
covered to maintain blinding. 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
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Name of Sponsor: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone injectable suspension 
Name of Active Ingredient: Lurasidone (DSP-1349M) 
Doses of 75, 150, 300, and 450 mg may be administered (ie, cohorts 2-5). 
Duration of Treatment 
The maximum duration for study participation for each subject will be up to approximately 96 days. 
Subjects will receive oral lurasidone 80 mg doses on Days -7 and -6 (one tablet each day) with 
approximately 240 mL of water. 
Subjects who tolerate dosing with oral lurasidone 80 mg will receive a single lurasidone injectable 
suspension or placebo injection dose on Day 1. 
Reference Therapy, Dosage and Mode of Administration 
Lurasidone 80 mg will be provided as the commercially available oral tablet formulation (Latuda®). 
Placebo for lurasidone injectable suspension will be provided. The solution will be packaged in clear 
USP Type I glass vials with rubber stoppers. 
Placebo for lurasidone injectable suspension will be administered to subjects using syringe and 
gauge 22-23 needle. The syringe will be covered to maintain blinding. 
Prior and Concomitant Medications 
In accordance with the approved product labeling for Latuda (see approved product labeling), lurasidone 
should not be used concomitantly with a strong CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, 
ritonavir, voriconazole, mibefradil). Lurasidone should not be used concomitantly with a strong 
CYP3A4 inducer (eg, rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine). A list of strong 
CYP3A4 inhibitors and inducers included in Section 23, Appendix V). 
All prior antidepressants and mood stabilizers (eg, lithium, divalproex/valproic acid, carbamazepine) 
must be discontinued as tolerated and clinically appropriate starting on Day -12. All other psychotropic 
medication (except as described in Section 9.5.3), including antipsychotic medication, must be 
discontinued as tolerated and clinically appropriate starting on Day -12 in a manner that is consistent 
with labeling recommendations and conventional medical practice. 
Non-psychotropic medications used to treat mild, chronic medical conditions may be used during 
Screening and after assignment of a subject number, if the dose and regimen have been stable (± 25%) 
for at least 30 days prior to Screening. The concomitant medication dose may change as needed after a 
subject number is assigned (or be discontinued). In addition, use of nonprescription pain medications are 
allowed during all phases of the study provided these medications do not have a propensity for 
psychotropic effects and do not interfere with the evaluation of study medication. Medications for 
short-term treatment of a medical condition (no more than 10 days) are allowed with consultation with 
the Medical Monitor, provided that the medications are not drugs that prolong the QT/QTc interval or 
CYP3A4 inhibitors or inducers (see Section 22, Appendix IV and Section 23, Appendix V, 
respectively). 
During the washout, treatment and post-treatment periods, treatment with benztropine (up to 6 mg/day) 
will be permitted as rescue medication and as treatment for movement disorders. In cases where 
benztropine is not available or a subject has had an inadequate response or intolerability to benztropine 
treatment, the following medications may be used to treat acute extrapyramidal symptoms (EPS): 
biperiden (up to 16 mg/day) or trihexyphenidyl (up to 15 mg/day) or diphenhydramine (up to 
100 mg/day). Treatment with amantadine (up to 300 mg/day) will be permitted as needed for akathisia. 
Medications used to treat movement disorders should not be given prophylactically. Medications used 
for movement disorders should be tapered and discontinued prior to a subject number is assigned but 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
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13 June 2018 
Name of Sponsor: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone injectable suspension 
Name of Active Ingredient: Lurasidone (DSP-1349M) 
may be reinstituted if symptoms emerge. 
In situations where anticholinergic agents or any other agents that may cause sedation are administered, 
these should be taken at the same time each day and should not be taken within 12 hours of scheduled 
assessments. When the specified drugs are not available, similar drugs at equivalent dosages will be 
substituted in consultation with the Medical Monitor. Concomitant use of lorazepam, temazepam, or 
zolpidem is permitted with the following restrictions: lorazepam is permitted for clinically significant 
anxiety/agitation or as a sedative/hypnotic up to a maximum daily dose of 6 mg/day. Intramuscular 
lorazepam is permitted up to 4 mg/day for acute anxiety/agitation, as clinically indicated. Lorazepam 
should be used sparingly, when clinically required, per Investigator judgment. Zolpidem (≤ 10 mg in any 
24-hour period) and temazepam (≤ 30 mg in any 24-hour period) may be administered, as needed, as 
sedatives/hypnotics. Hypnotic agents should be administered no more than once nightly and should not 
be used in combination. 
Medications used for the as-needed (PRN) treatment of anxiety/agitation and insomnia (eg, lorazepam 
and zolpidem) should not be used in close temporal proximity (defined as administration within 2 hours 
of each other). When lorazepam or zolpidem or other specified medications are not available, another 
similar agent at equivalent doses will be permitted as specified by the Medical Monitor. Opiates may be 
allowed in rare cases for a limited period of time with prior authorization from the Medical Monitor. 
Subjects who require treatment with one or more of the medications listed in Section 22, Appendix IV or 
Section 23, Appendix V should be excluded or discontinued (as appropriate) from the study. Since these 
lists of drugs are not comprehensive, Investigators should use medical judgment when a subject presents 
with a medication not on the list or consult with the Medical Monitor for clarification. 
A complete listing of permitted medications and therapies, including rescue medications, as well as a 
complete listing of prohibited medications are provided in Section 9.5. 


Protocol D1052024, Version 2.00 
 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
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13 June 2018 
Name of Sponsor: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone injectable suspension 
Name of Active Ingredient: Lurasidone (DSP-1349M) 
Criteria for Evaluation: 
Safety Endpoints 
• 
Incidence of AEs, serious adverse events (SAEs), and AEs leading to study discontinuation 
• 
Incidence of injection site-related reactions, including injection site pain, injection site 
erythema, injection site induration, injection site ulcer, injection site granuloma and 
injection site swelling 
• 
Observed values and changes from baseline in clinical laboratory tests (hematology, serum 
chemistry, urinalysis, coagulation, and liver function), vital signs (respiratory rate, body 
temperature, supine blood pressure, and pulse), orthostatic effects (based on blood pressure 
and heart rate), and 12-lead electrocardiograms (ECGs) parameters 
• 
Incidence and severity of subjects with suicidal ideation or suicidal behavior using the 
Columbia-Suicide Severity Rating Scale (C-SSRS) 
Pharmacokinetic Endpoints 
• 
PK parameters for lurasidone after Lurasidone injectable suspension Administration 
Serum: Cmax, tmax, AUC0-last, AUC0-inf, λz, t1/2, CL/F, and Vz/F 
Urine: Ae0-144h, fe, and CLR 
• 
PK parameters for metabolites after Lurasidone injectable suspension Administration 
Serum: Cmax, tmax, AUC0-last, AUC0-inf, λz, t1/2, metabolite to parent ratio of AUC0-inf 
(MRAUC0-inf), and Cmax (MRCmax) for ID-14283, ID-14326, ID-11614, ID-20219, and 
ID-20220 
Urine: Ae0-144h for ID-14283, ID-14326, and ID-11614 
Pharmacodynamic Endpoint 
• 
Change from baseline, and placebo-corrected change from baseline in Positive and Negative 
Syndrome Scale (PANSS) total score 
Statistical Methods 
Safety Analyses 
The safety analysis will be conducted by the treatment received using the Safety population, which will 
consist of all subjects who are randomized and receive study drug. AEs and all other safety data will be 
listed and summarized descriptively by treatment group (dose level of Lurasidone injectable suspension 
and placebo) in tabular or graphical formats, as appropriate. Subjects dosed with placebo will be 
analyzed as a pooled group. Observed values, as well as change from baseline for clinical safety 
laboratories, vital signs, and ECGs will be listed and summarized descriptively in tabular or graphical 
formats, as appropriate. Any clinically significant results in clinical safety laboratories, vital signs, and 
ECGs will be listed and summarized. Frequency and severity of suicidality, based on the C-SSRS, will 
be summarized. 
Pharmacokinetic Analyses 
The PK analysis will be conducted on the PK population, which will consist of all subjects who are 
randomized and receive Lurasidone injectable suspension, have at least one measurable postdose 
concentration, and have had no relevant protocol deviations or documented reason that a PK profile was 
unreliable. Subjects will be analyzed according to treatment received. Serum and urine concentrations 


Protocol D1052024, Version 2.00 
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Name of Sponsor: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone injectable suspension 
Name of Active Ingredient: Lurasidone (DSP-1349M) 
and PK parameters for Lurasidone injectable suspension and its metabolites will be listed and 
summarized descriptively by dose level and subdivided by gender in tabular or graphical formats, as 
appropriate. Descriptive summaries will include number of subjects, mean, standard deviation, 
coefficient of variation (CV%), minimum, median, maximum, geometric mean, and geometric CV%. 
Cmax, tmax, AUC0-last, and AUC0-inf for Lurasidone injectable suspension will be the primary PK 
parameters and all others will be secondary PK parameters. 
Dose proportionality of Lurasidone injectable suspension will be assessed using a power model for Cmax, 
AUC0-last, and AUC0-inf of Lurasidone injectable suspension with a formula of ln (PK 
parameter) = α + β⋅ln (dose level). 
The estimate of the slope (β), together with its 90% confidence interval (CI) will be calculated from the 
model. Dose proportionality assessment will be performed for the dose range studied. 
Pharmacodynamic (PD) Analyses 
The pharmacodynamic variable is change from baseline in PANSS total score. The pharmacodynamic 
variable will be analyzed by mixed model for repeated measures (MMRM) method. The MMRM model 
will include treatment, time, baseline score, and treatment-by-time interaction. 
Sample Size: 
There will be no formal estimation for the sample size as no previous human PK data are available for 
Lurasidone injectable suspension and the primary endpoints are safety. The sample size of 8 subjects per 
cohort (6 Lurasidone injectable suspension subjects and 2 placebo subjects) is selected based on clinical 
and practical considerations for a study of this design. 


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Table 2: Schedule of Assessments 
Study Period 
Screen 
Washout/Tapera 
Treatment/Observationa 
Restabilizationa 
Follow-up 
Study Day 
-35 to -13 
-12 
-11 to -9 
-8 
-7 
-6 
-5 to -1 
1 
2-8 
9-14 
15 
22 
29 
30-32 
33 
61 ± 2 
Procedures/Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Obtain Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Review Inclusion/ 
Exclusion Criteria 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Record Medical and 
Psychiatric History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Perform Physical 
Examination 
X 
X 
 
X 
 
 
 
 
 
 
X 
 
X 
 
X 
X 
Record Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record Weight and BMI 
X 
 
 
X 
 
 
 
 
 
 
 
 
X 
 
X 
X 
Obtain Vital Sign 
Measurementsb 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Perform 12-Lead ECGc 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
 
X 
X 
Clinical Laboratory Testsd 
X 
 
 
X 
 
 
 
X 
X 
 
X 
X 
X 
 
X 
X 
Serum Prolactine 
X 
 
 
X 
 
 
 
X 
X 
 
X 
X 
X 
 
X 
X 
Serology 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum Pregnancy Test 
(females)  
X 
X 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
 
Urine Drug Screen 
X 
X 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
 
Urine Alcohol Test 
X 
X 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
 
Blood Samples for PKf 
 
 
 
 
X 
X 
 
X 
X 
 
X 
X 
X 
 
 
X 
Urine Samples for PKg 
 
 
 
 
 
 
 
X 
X 
 
 
 
 
 
 
 
Psychotropic Medicationsh,i 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
 
Administer 
Columbia-Suicidality 
Severity Rating Scale 
(C-SSRS)j 
X 
 
 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
Administer Positive and 
Negative Syndrome Scale 
(PANSS)k 
X 
 
 
 
X 
 
 
X 
X 
 
X 
X 
X 
 
 
 
Clinical Site Admissiona 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 


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Table 2: 
Schedule of Assessments (Continued) 
Study Period 
Screen 
Washout/Tapera 
Treatment/Observationa 
Restabilizationa 
Follow-up 
Study Day 
-35 to -13 
-12 
-11 to -9 
-8 
-7 
-6 
-5 to -1 
1 
2-8 
9-14 
15 
22 
29 
30-32 
33 
61 ± 2 
Procedures/Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Awaken Subject 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Provide Mealsl 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Randomize Subject 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Dispense Oral Lurasidone 
 
 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
Oral Lurasidone 
Administrationm 
 
 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
Dispense Lurasidone or 
Placebo Injection 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Lurasidone or Placebo 
Injection Administration 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Investigator Injection Site 
Safety Assessmentn 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
 
 
Subject Injection Site Pain 
Assessmento 
 
 
 
 
 
 
 
X 
X 
 
X 
X 
X 
 
 
 
Schedule Next Visit 
X 
 
 
 
 
 
 
 
 
 
X 
X 
 
 
X 
 
Clinical Site Dischargep 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
 
X 
 
Concomitant Medicationsq 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Pretreatment Events 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse Eventsr 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Note: Subjects who discontinue the study prior to Day 29 will undergo assessments scheduled for Day 29 at the time of discontinuation. Subjects who 
discontinue the study after Day 29 but prior to Day 61 will undergo assessments scheduled for Day 61 at the time of discontinuation. 
a Eligible subjects must be washed out/tapered off of their current antipsychotic medications within 5 to 6 half-lives prior to Day -8 (may begin Day -19). 
Mandatory inpatient periods are Day -12 to Day 15 (for treatment and observation) and Day 29 to Day 33 (for restabilization to previous medications; 
restabilization begins Day 29). Subjects may remain inpatient until Day 33 at the Investigator’s discretion. 
b Vital signs = Blood pressure (supine and standing), pulse rate (supine and standing), respiration rate, and body temperature will each be collected at the 
following times 
• 
Day -12 and Day -8: once daily 
• 
Days -7 and -6: predose and 2 hours postdose  
• 
Day -1 
• 
Day 1 pre-injection dose and 6 and 12 hours post-injection dose 
• 
Days 3, 5, 7, 9, 11, 13, and 15 (time-matched to the predose timepoint on Day 1), and Days 22, 29, and 33 (approximately time-matched to the predose 
timepoint on Day 1), and Follow-up. 


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Note: Supine blood pressure and pulse rate should be collected at the same time as 12-lead ECG (when 12-lead ECG is collected for the same timepoint). A 
window of ± 10 minutes of scheduled time is allowed. After Cohort 1, timepoints for vital signs may be changed based on observed tmax of Lurasidone 
injectable suspension and its metabolites. 
c Standard 12-lead ECGs will be collected at Screening and during the washout/taper period on Days -12 and -8. On Days -7 and -6, standard 12-lead ECGs will 
be collected predose and 2 hours postdose. Standard 12-lead ECGs will be collected predose and 6, and 12 hours post injection dose on Day 1 and on Days 3, 
5, 7, 9, 11, 13, and 15 (time-matched to the predose timepoint on Day 1), and Days 22, 29, and 33 (approximately time-matched to the predose timepoint on 
Day 1), and Follow-up. A window of ± 15 minutes of scheduled time is allowed for ECGs performed up to and including Day 15. After Cohort 1, these 
timepoints may be changed based on observed tmax of Lurasidone injectable suspension and its metabolites. 
d Hematology, Serum Chemistry, Urinalysis, Lipid Panel, Coagulation Panel, and Thyroid Panel. 
•
Subjects are to fast ≥ 8 hours prior to blood sample collection for clinical laboratory tests.
•
Blood samples will be collected for Hematology and Serum Chemistry at screening, Day -8, Day 1 injection predose , Days 8 and 15 (time-matched to
the predose timepoint on Day 1), and Days 22, 29, and 33 (approximately time-matched to the injection predose sample on Day 1), and follow-up. A
window of ± 10 minutes is allowed for clinical laboratory test sample collection. Samples will be obtained at the same time that other blood and urine
samples are taken whenever possible.
•
Blood samples for thyroid panel, coagulation panel, and lipid panel will be collected at Screening, Day -8 , Day 1 injection predose , Day 15
(time-matched to the predose timepoint on Day 1), and Day 29 (approximately time-matched to the injection predose sample on Day 1).
•
Urinalysis will be collected at screening, Day -8, Day 1 injection predose (time-matched to the predose timepoint on Day 1), Days 8 and 15
(time-matched to the predose timepoint on Day 1), and Days 22, 29, and 33 (approximately time-matched to the injection predose sample on Day 1),
and follow-up.
e Serum Prolactin levels will be blinded, except at screening and Day 1. Designated unblinded medical site staff will be notified if prolactin concentrations are 
> 200 ng/mL. Blood samples will be collected on Day -8, Day 1 injection predose, Days 8 and 15 (time-matched to the predose timepoint on Day 1), and 
Days 22, 29, and 33 (approximately time-matched to the injection predose timepoint on Day 1), and follow-up. 
f Blood samples for serum PK assessment will be collected at predose and 2 hours postdose on Days -7 and -6, and then at 0 hour (predose), 2, 4, 6, 12, 24, 48, 
72, 96, 120, 144, 336, 504, 672, and 1440 (± 48) hours after the injection dose given on Day 1. A window of ± 5 minutes of scheduled time (up to 8 hours 
postdose), and ± 10 minutes of scheduled time (from 12 hours postdose onward) is allowed. Blood sampling timepoints for PK assessment for subsequent 
cohorts may be modified based on serum concentration data from initial cohort(s). Evaluation of the relationship between the timing of below limit of 
quantification (BLQ) and the elimination half-life will be used to justify the revised blood sampling for PK and safety assessment schedule. 
g Urine samples for PK assessment will be collected at the following intervals: -0.5 to 0 hour (predose); 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, and 120 
to 144 hours after the injection dose given on Day 1, and recording of the volume of urine sample at each time interval. Urine samples collected for PK analysis 
may also be used for the additional characterization and/or bioanalytical method development of putative metabolites of DSP-1349M and for biomarker 
measurement, if needed. 
h Tapering of patient’s psychotropic medications prior to entry to the study has been done routinely in previously conducted studies with lurasidone. The exact 
timing and method of taper will depend on the subject’s medication regimen, but the tapering process will typically start approximately one week prior to 
Day -12 admission. However, for some subjects, the tapering process will begin sooner than one week and some may begin later than one week from Day -12 
admission based on PI’s evaluation. 
i Restabilization’ refers to the reintroduction of each subject’s prior medications that were taken prior to entry into the study including their psychotropic 
medications. The inpatient restabilization for reintroduction of prior medications including psychotropics may be longer, if needed. For early termination 
patients who received lurasidone dosing, following follow-up procedures they will need to be restabilized following the restabilization procedures. 


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j The C-SSRS will be administered at Screening, during the Treatment/Observation period on Day -8 (ie, pre-oral dosing), Day -7 (postdose), Day -1 
(pre-injection dose), Day 1 (postdose), and Days 7, 15, 22, and 29, at the end of restabilization on Day 33, and at follow-up Day 61 ± 2. The Screening/Baseline 
and Since Last Visit Versions of the C-SSRS will be utilized in this study. 
k PANSS will be administered once during Screening, and on Days -7, 1 (predose), 8, 15, 22, and 29. 
l Lunch will be provided ≥ 4 hours postdose on Days -7, -6 and 1. Standard meals will be provided during the inpatient period and outpatient clinic return visits 
on when applicable. 
m Subjects will fast overnight for at least 8 hours on Day -8 and Day -7. On Days -7 and -6, standard breakfast (minimum 350 calories) will be served 30 minutes 
prior to the planned dosing time. Dosing of lurasidone 80 mg orally will take place 30 minutes after the start of breakfast. Subjects will receive dose 
administration at approximately the same time on each day of dosing during the study. Lurasidone 80 mg will be administered with approximately 240-mL 
water on Days -7 and -6. Water intake is restricted for one hour before and two hours after dose administration; after which water will be allowed ad libitum. 
Subjects will fast for 4 hours after dosing on Day -7 and on Day -6. 
n Investigator injection site safety assessment will include a rating of 1-4 on each of 4 items (pain, tenderness, erythema/redness, and induration/swelling ). 
Assessments will be made on Day 1 (immediately after injection, and 6 hours and 12 hours after injection), Day 2 (24 hours after injection), Days 3-15 (daily 
during the inpatient period), Day 22, and Day 29. A window of +1 minute is allowed for the immediately after injection timepoint, and a window of ± 5 
minutes is allowed for the 6 and 12 hour timepoints on Day 1. In addition subjects will be monitored for potential allergic reaction for 15 minutes after 
injection. A window of 0-5 minutes is allowed for the evaluation of potential allergic reaction. 
o Subjects will assess their injection site pain using a rating of 0-10 on a Likert Scale (0 = no pain, 10 = worst pain). This assessment will be completed prior to 
the Investigator injection site assessment on Day 1 (immediately after injection, and 6 hours and 12 hours after injection), Day 2 (24 hours after injection), 
Day 8, Day 15, Day 22, and Day 29. A window of +1 minute is allowed for the immediately after injection timepoint, and a window of ± 5 minutes is allowed 
for the 6 and 12 hour timepoints on Day 1. 
p Alternate subjects not included in the study cohort will be discharged following reintroduction of their prior medication if they are clinically stable (in the 
Investigator’s opinion), subjects who received study drug will be eligible for discharge on Day 15 (but may remain inpatient at the Investigator’s discretion up 
to Day 33), and early withdrawal subjects will be discharged after follow-up assessment procedures. 
q Concomitant medications will be recorded prior to and after oral and injection dosing. 
r In addition to any untoward medical occurrences in the subject (pre and postdose on dosing days), assessment of the injection site and monitoring of prodromal 
symptoms for seizures will be performed. If prodromal symptoms for seizure are found, additional neurological assessments will be done, as needed. 
 


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TABLE OF CONTENTS 
RESTRICTED DISTRIBUTION OF PROTOCOLS ......................................................................2 
EMERGENCY CONTACTS...........................................................................................................3 
1. 
SYNOPSIS ...................................................................................................................4 
2. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS.............................22 
3. 
INTRODUCTION ......................................................................................................25 
3.1. 
Background .................................................................................................................25 
3.2. 
Study Conduct Rationale ............................................................................................26 
3.3. 
Risk-Benefit Assessment ............................................................................................26 
4. 
STUDY OBJECTIVES ..............................................................................................26 
4.1. 
Safety Objective ..........................................................................................................26 
4.2. 
Pharmacokinetic and Pharmacodynamic Objectives ..................................................26 
5. 
STUDY ENDPOINTS ................................................................................................27 
5.1. 
Safety Endpoints .........................................................................................................27 
5.2. 
Pharmacokinetic Endpoints ........................................................................................27 
5.3. 
Pharmacodynamic Endpoint .......................................................................................27 
6. 
INVESTIGATIONAL PLAN .....................................................................................28 
6.1. 
Overall Study Design ..................................................................................................28 
6.2. 
Treatment Assignment and Blinding ..........................................................................29 
6.2.1. 
Treatment Assignment ................................................................................................29 
6.2.2. 
Blinding ......................................................................................................................30 
6.2.3. 
Emergency Unblinding Procedures ............................................................................31 
6.3. 
Rationale .....................................................................................................................31 
6.3.1. 
Rationale for the Study Design ...................................................................................31 
6.3.2. 
Rationale for the Dosages ...........................................................................................31 
6.3.3. 
Rationale for the Study Population .............................................................................32 
6.4. 
Prevention of Missing Data ........................................................................................32 
7. 
SELECTION OF SUBJECTS ....................................................................................33 
7.1. 
Subject Inclusion Criteria ...........................................................................................33 
7.2. 
Subject Exclusion Criteria ..........................................................................................34 
8. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................36 
8.1. 
Description of Study Drug ..........................................................................................36 


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8.2. 
Study Drug Packaging and Labeling ..........................................................................37 
8.2.1. 
Package Description ...................................................................................................37 
8.2.2. 
Labeling Description ..................................................................................................37 
8.3. 
Study Drug Storage .....................................................................................................37 
8.4. 
Dispensing of Study Drug ..........................................................................................38 
8.5. 
Study Drug Accountability .........................................................................................38 
8.6. 
Study Drug Handling and Disposal ............................................................................38 
9. 
TREATMENT OF SUBJECTS ..................................................................................39 
9.1. 
Study Drug ..................................................................................................................39 
9.2. 
Dose Escalation/Safety Cohort Review ......................................................................39 
9.3. 
Determination of the MID and MTD ..........................................................................39 
9.4. 
Treatment Compliance ................................................................................................41 
9.5. 
Prior and Concomitant Medications ...........................................................................41 
9.5.1. 
Prior Medications ........................................................................................................42 
9.5.2. 
Concomitant Nonpsychotropic Medications ..............................................................42 
9.5.3. 
Concomitant Psychotropic Medications .....................................................................42 
9.5.4. 
Prohibited Medications ...............................................................................................43 
9.6. 
Contraception Requirements ......................................................................................43 
9.7. 
Guidance for Overdose ...............................................................................................44 
9.8. 
Dietary Restrictions ....................................................................................................45 
10.
STUDY ASSESSMENTS ..........................................................................................45
10.1. 
Demographics and Baseline Characteristics ...............................................................45 
10.2. 
Safety Assessments .....................................................................................................45 
10.2.1. 
Pretreatment Events and Adverse Events ...................................................................46 
10.2.2. 
Clinical Laboratory Tests ...........................................................................................46 
10.2.3. 
Physical Examinations ................................................................................................46 
10.2.4. 
Injection Site Assessments .........................................................................................46 
10.2.4.1. 
Investigator Injection Site Assessments .....................................................................46 
10.2.4.2. 
Subject Injection Site Assessments ............................................................................46 
10.2.5. 
Weight, Body Mass Index, and Height .......................................................................47 
10.2.6. 
Vital Signs ..................................................................................................................47 
10.2.7. 
12-Lead ECG ..............................................................................................................47 
10.2.8. 
Columbia-Suicidality Severity Rating Scale (C-SSRS) .............................................47 


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10.3. 
Pharmacokinetic Assessments ....................................................................................48 
10.4. 
Pharmacodynamic Assessment (PANSS)...................................................................50 
10.5. 
Study Visits and Assessments ....................................................................................50 
10.5.1. 
Days -35 to -13 (Screening) ........................................................................................50 
10.5.2. 
Washout/Taper Period: Days -12 to -8 .......................................................................51 
10.5.2.1. 
Day -12 (Washout/Taper) ...........................................................................................51 
10.5.2.2. 
Days -11 to -9 (Washout/Taper) .................................................................................52 
10.5.2.3. 
Day -8 (End of Washout/Taper Period) ......................................................................52 
10.5.3. 
Treatment/Observation Period, Days -7 to 28 ............................................................53 
10.5.3.1. 
Day -7 (Oral Lurasidone Dosing) ...............................................................................53 
10.5.3.2. 
Day -6 (Oral Lurasidone Dosing) ...............................................................................54 
10.5.3.3. 
Days -5 to -1 (Safety and Tolerability Observation) ..................................................54 
10.5.3.4. 
Day 1 (Baseline/Randomization and Lurasidone or Placebo Injection 
Dosing) .......................................................................................................................55 
10.5.3.5. 
Days 2 to 8 (Safety and Tolerability Observation) .....................................................56 
10.5.3.6. 
Days 9 to 14 (Safety and Tolerability Observation) ...................................................57 
10.5.3.7. 
Day 15 (Safety and Tolerability Observation) ............................................................57 
10.5.3.8. 
Day 22 (Safety and Tolerability Observation) ............................................................58 
10.5.4. 
Days 29 to 33 (End of Safety and Tolerability Observation and Beginning of 
Restabilization) ...........................................................................................................59 
10.5.4.1. 
Day 29 (End of Safety and Tolerability Observation and Beginning of 
Restabilization) ...........................................................................................................59 
10.5.4.2. 
Days 30-32 (Restabilization) ......................................................................................60 
10.5.4.3. 
Day 33 (End of Restabilization) .................................................................................60 
10.5.5. 
Follow-up/Study Completion, Day 61 ± 2 .................................................................61 
11. 
SAFETY REPORTING ..............................................................................................62 
11.1. 
Definitions ..................................................................................................................62 
11.1.1. 
Adverse Events ...........................................................................................................62 
11.1.2. 
Serious Adverse Events ..............................................................................................62 
11.2. 
Objective Findings ......................................................................................................63 
11.3. 
Collection and Recording of Adverse Events .............................................................64 
11.4. 
Immediately Reportable Events ..................................................................................65 
11.4.1. 
Serious Adverse Event ................................................................................................65 


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11.4.2. 
Pregnancy ...................................................................................................................66 
12. 
TERMINATION OF SUBJECT FROM STUDY/DISCONTINUATION OF 
STUDY DRUG ...........................................................................................................67 
12.1. 
Criteria for Subject Termination .................................................................................67 
13. 
STUDY TERMINATION ..........................................................................................68 
14. 
STATISTICS ..............................................................................................................68 
14.1. 
Sample Size ................................................................................................................68 
14.2. 
Analysis Populations ..................................................................................................68 
14.3. 
Data Analysis ..............................................................................................................69 
14.3.1. 
Subject Disposition .....................................................................................................69 
14.3.2. 
Drug Exposure and Compliance .................................................................................69 
14.3.3. 
Important Protocol Deviations ....................................................................................69 
14.3.4. 
Demographic and Baseline Characteristics ................................................................69 
14.3.5. 
Safety Analyses ..........................................................................................................70 
14.3.5.1. 
Adverse Events ...........................................................................................................70 
14.3.5.2. 
Clinical Laboratory Assessments ...............................................................................70 
14.3.5.3. 
ECGs/Centrally-read ECG/Holter Monitor ................................................................71 
14.3.5.4. 
Vital Signs ..................................................................................................................71 
14.3.5.5. 
Columbia-Suicide Severity Rating Scale (C-SSRS) ...................................................71 
14.3.5.6. 
Physical Examination .................................................................................................72 
14.3.5.7. 
Investigator Injection Site Safety Assessment and Subject Injection Site Pain 
Assessment .................................................................................................................72 
14.3.5.8. 
Concomitant Medications ...........................................................................................72 
14.3.5.9. 
Safety Subgroup Analyses ..........................................................................................72 
14.3.6. 
Pharmacokinetic Analysis ..........................................................................................72 
14.3.7. 
Pharmacodynamic Analyses .......................................................................................73 
14.3.8. 
Interim Analysis ..........................................................................................................73 
14.3.9. 
Treatment of Missing Data .........................................................................................73 
15. 
PROCEDURE FOR CLINICAL STUDY QUALITY CONTROL/ DATA 
COLLECTION, MANAGEMENT, AND QUALITY ASSURANCE ......................73 
15.1. 
Data Collection/Electronic Data Capture (EDC) ........................................................73 
15.2. 
Computerized Systems Used for Source Data ............................................................73 
15.3. 
Study Monitoring ........................................................................................................75 


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15.4. 
Audits ..........................................................................................................................75 
15.5. 
Study Documentation .................................................................................................75 
15.6. 
Clinical Laboratory Certification and Normal Values ................................................75 
16. 
ETHICAL AND REGULATORY OBLIGATIONS..................................................76 
16.1. 
Study Conduct ............................................................................................................76 
16.2. 
Institutional Review Board/Independent Ethics Committee ......................................76 
16.3. 
Informed Consent .......................................................................................................77 
16.4. 
Subject Privacy ...........................................................................................................77 
16.5. 
Protocol Amendments and Emergency Deviations ....................................................78 
16.6. 
Records Retention .......................................................................................................78 
16.7. 
Inspection of Records .................................................................................................78 
16.8. 
Financial Disclosure ...................................................................................................78 
16.9. 
Publication Policy .......................................................................................................79 
16.10. 
Compensation .............................................................................................................79 
17. 
REFERENCES ...........................................................................................................80 
18. 
INVESTIGATOR APPROVAL .................................................................................81 
19. 
APPENDIX I. CARDIAC SAFETY MONITORING (ECG) ....................................82 
20. 
APPENDIX II. CLINICAL LABORATORY TESTS ...............................................83 
21. 
APPENDIX III. BLOOD AND URINE SAMPLE COLLECTION AND 
HANDLING GUIDELINES FOR PHARMACOKINETICS ....................................84 
22. 
APPENDIX IV. DRUGS KNOWN TO CONSISTENTLY PROLONG THE 
QT INTERVAL ..........................................................................................................86 
23. 
APPENDIX V. ADDITIONAL RESTRICTED SUBSTANCES ..............................87 
24. 
APPENDIX VI: BODY MASS INDEX DETERMINATION ..................................88 
 
 
 


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LIST OF TABLES 
Table 1: 
Emergency Contact Information ...................................................................................3 
Table 2: 
Schedule of Assessments ............................................................................................12 
Table 3: 
List of Abbreviations ..................................................................................................22 
Table 4: 
Definition of Key Study Terms ..................................................................................24 
Table 5: 
Investigational Product ...............................................................................................37 
Table 6: 
Computerized Systems Used for Source Data ............................................................74 
 
LIST OF FIGURES 
Figure 1: 
Study Schematic – All Subjects ..................................................................................28 
 


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2. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
The abbreviations and the definition of key study terms used in the clinical study protocol are 
shown in Table 3 and Table 4. 
Table 3: List of Abbreviations 
Abbreviation 
Full Form 
AE 
Adverse event 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
ATC 
Anatomical Therapeutic Chemical 
BMI 
Body mass index  
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CLIA 
Clinical Laboratory Improvement Amendments 
CRF 
Case report form (or electronic case report form) 
CRO 
Contract research organization 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
CV 
Coefficient of variation 
ECG 
Electrocardiogram 
EDC 
Electronic data capture 
EPS 
Extrapyramidal symptoms 
FDA 
U.S. Food and Drug Administration 
GCP 
Good Clinical Practice 
hCG 
Human chorionic gonadotropin 
ICF 
Informed consent form 
ICH 
International Council on Harmonisation 
IEC 
Independent Ethics Committee  
IND 
Investigational New Drug 
IPD 
Important protocol deviation 
IRB 
Institutional Review Board 
IUD 
Intrauterine device 
IXRS 
Interactive Voice/Web-based Response System 
MedDRA 
Medical Dictionary for Regulatory Activities 


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Table 3: List of Abbreviations (continued) 
Abbreviation 
Full Form 
MMRM 
Mixed model for repeated measures 
PANSS 
Positive and Negative Syndrome Scale 
PK 
Pharmacokinetic(s) 
PR 
Time between P wave and QRS in electrocardiography 
PT 
Preferred term 
PVG 
Pharmacovigilance 
QRS 
Electrocardiographic wave (complex or interval) 
QT 
Electrocardiographic interval from the beginning of the QRS complex to the 
end of the T wave 
QTc 
QT interval corrected for heart rate 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SOC 
System organ class 
SOP 
Standard Operating Procedure 
SRT 
Safety review team 
US 
United States 
 


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Table 4: Definition of Key Study Terms 
Terms 
Definition of terms 
CRF 
A printed, optical, or electronic document designed to record all of the 
protocol required information to report to the Sponsor for each study 
subject. 
Screened Subject 
Any subject who signed the study specific informed consent and completed 
at least one study related procedure. 
Screen Failures 
Any subject who signed the study specific informed consent but either 
failed to meet study requirements during screening or met study 
requirements at screening but was not enrolled/randomized. 
Study Drug (or Study 
medication) 
Term to cover investigational drug, placebo, and/or active control. 
Treatment Period 
The period of the study in which the study drug is administered. 
Randomized Subject 
Any subject who was randomized into the treatment period of the study and 
was assigned a randomization number. 
Enrolled Subject 
Any subject who was successfully screened and enrolled into the 
pre-randomization period of the study. 
Randomization Failures 
Any subject who was enrolled but not randomized. 
Completed Subject 
Any subject who participated throughout the duration of the study, up to 
and including Day 29. 
Early Termination 
Subject 
Any subject who was successfully screened and randomized into the 
treatment period of the study, but did not complete the study. 
End of Treatment 
The day that the subject receives the protocol-defined last dose of the study 
drug. 
End of Study 
The day of the last visit by the last subject in the study. 


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3. 
INTRODUCTION 
3.1. 
Background 
Lurasidone injectable suspension (DSP-1349M) is a novel compound synthesized by Sumitomo 
Dainippon Pharma Co., Ltd., as a candidate psychotropic agent for the treatment of patients with 
schizophrenia. It possesses high affinities for dopamine D2, serotonin 5 HT2A, 5 HT7, 5 HT1A 
and noradrenaline α2C receptors. Compared with other atypical antipsychotics, lurasidone 
demonstrates similar binding affinities for the D2 and 5 HT2A receptors, but greater affinity for 
serotonin 5 HT1A receptors. Lurasidone displays no affinity for histamine H1 or acetylcholine 
M1 receptors. 
Lurasidone has a unique chemical structure that differs from conventional antipsychotic 
therapies such as the phenothiazine, butyrophenone, and benzamide classes of antipsychotic 
agents. The chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3 
yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione 
hydrochloride. Due to its serotonin 5 HT2 blocking actions, lurasidone is associated with fewer 
extrapyramidal symptoms (EPS) than conventional antipsychotic therapeutic agents and is 
effective in ameliorating the positive and negative symptoms of schizophrenia. In preclinical 
pharmacological studies, lurasidone has been shown to be effective in various animal models of 
schizophrenia and to have weak potential for inducing EPS. 
In general, the slow release characteristics (pharmacokinetics) of several current long acting 
injectable antipsychotics is attributed to either the rate of hydrolysis of the ester form of the 
antipsychotic molecule by esterases in muscle or to the slow rate of diffusion of the esterified 
antipsychotic from an oil vehicle. In contrast, injectable lurasidone is the free base of lurasidone 
hydrochloride that is placed in an aqueous solution as a suspension. Free base lurasidone has 
very low solubility in aqueous solution, so when injected into muscle, dissolution of freebase 
lurasidone in a limited aqueous surrounding governs the clearance from muscle into serum. 
Schizophrenia is a severe psychiatric disorder that has a profound effect on both the individuals 
affected and society (Owen, 2016). Schizophrenia occurs at an incidence of roughly 15 men and 
10 women per 100,000 populations per year, a point prevalence of 4.6 per 1,000, and a lifetime 
morbid risk of around 0.7% (McGrath, 2008). A coherent body of evidence from 
pharmacological and brain-imaging studies implicates dysfunction of dopaminergic 
neurotransmission in the genesis of psychotic symptoms such as delusions and hallucinations 
(Howes, 2014). 
Unemployment in people with schizophrenia is 80% to 90% (Marwaha, 2004), and in 2013, the 
estimated societal economic burden of schizophrenia was estimated to be approximately 
$156 billion in the US (Cloutier, 2016). 
Mortality from most natural causes, especially cardiovascular disorders, is the strongest 
contributor to the 10 to 20 year reduction in life expectancy (Chesney, 2014). There is a clear 
need to develop antipsychotic compounds with reduced side effects, particularly those affecting 
metabolic processes that result in adverse cardiovascular outcomes (Miyamoto, 2012). 


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3.2. 
Study Conduct Rationale 
Non-adherence in medication-taking remains one of the major challenges in the treatment of any 
chronic illness such as schizophrenia. Numerous studies have found high levels of 
non-adherence in medication taking in patients with schizophrenia. One potentially valuable 
approach to enhancing adherence is the use of long-acting injectable antipsychotic medications. 
This study is being conducted to evaluate the safety and tolerability of a single intramuscular 
(IM) injection of lurasidone injectable suspension (DSP-1349M) in adult subjects. This study 
will also determine the pharmacokinetic (PK) characteristics of lurasidone and its metabolites in 
serum and urine after single IM dose administration of lurasidone injectable suspension. 
3.3. 
Risk-Benefit Assessment 
The potential risks anticipated based on lurasidone clinical studies and lurasidone injectable 
suspension nonclinical studies conducted to date are amenable to detection via safety monitoring 
in this study (consisting of adverse event reporting, injection site reactions, vital sign 
assessments, electrocardiograms monitoring, clinical laboratory evaluations, physical 
examinations, and discontinuation summaries). The 28-day observation period after injection 
dosing is considered clinically appropriate for monitoring safety and tolerability. Similarly, the 
28-day observation/follow-up period after restabilization (ie, subjects re-starting their prior 
medications) is considered clinically appropriate for safety monitoring and to ensure subjects are 
clinically stable. 
4. 
STUDY OBJECTIVES 
4.1. 
Safety Objective 
• To assess safety, tolerability, and pharmacokinetics (PK) of a single dose of 
lurasidone injectable suspension in subjects with schizophrenia. 
4.2. 
Pharmacokinetic and Pharmacodynamic Objectives 
• To assess the PK for the metabolites of lurasidone in serum (ID-14283, ID-14326, 
ID-11614, ID-20219 and ID-20220 and in urine (ID-14283, ID-14326, and ID-11614) 
after a single dose of lurasidone injectable suspension. 
• To assess Positive and Negative Syndrome Scale (PANSS) in subjects with 
schizophrenia after a single dose of lurasidone injectable suspension. 


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5. 
STUDY ENDPOINTS 
5.1. 
Safety Endpoints 
• Incidence of AEs, serious adverse events (SAEs), and AEs leading to study 
discontinuation 
• Incidence of injection site-related reactions, including injection site pain, injection 
site erythema, injection site induration, injection site ulcer, injection site granuloma 
and injection site swelling 
• Observed values and changes from baseline in clinical laboratory tests (hematology, 
serum chemistry, urinalysis, coagulation, and liver function), vital signs (respiratory 
rate, body temperature, supine blood pressure, and pulse), orthostatic effects (based 
on blood pressure and pulse rate), and 12-lead electrocardiograms (ECGs) parameters 
• Incidence and severity of subjects with suicidal ideation or suicidal behavior using the 
Columbia-Suicide Severity Rating Scale (C-SSRS) 
5.2. 
Pharmacokinetic Endpoints 
• PK parameters for lurasidone after Lurasidone injectable suspension Administration 
- Serum: Cmax, tmax, AUC0-last, AUC0-inf, λz, t1/2, CL/F, and Vz/F 
- Urine: Ae0-144h, fe, and CLR 
• PK parameters for metabolites after Lurasidone injectable suspension Administration 
- Serum: Cmax, tmax, AUC0-last, AUC0-inf, λz, t1/2, metabolite to parent ratio of 
AUC0-inf (MRAUC0-inf), and Cmax (MRCmax) for ID-14283, ID-14326, ID-11614, 
ID-20219, and ID-20220 
- Urine: Ae0-144h for ID-14283, ID-14326, and ID-11614 
5.3. 
Pharmacodynamic Endpoint 
• Change from baseline, and placebo-corrected change from baseline in Positive and 
Negative Syndrome Scale (PANSS) total score 


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6. 
INVESTIGATIONAL PLAN 
6.1. 
Overall Study Design 
This is a single-center, randomized, double-blind, placebo-controlled, inpatient, single ascending 
dose (SAD) study designed to evaluate the safety, tolerability, and PK of lurasidone injectable 
suspension in subjects with schizophrenia. This study will determine the minimum intolerable 
dose (MID), the maximum tolerated dose (MTD) of lurasidone injectable suspension, and 
characterize the PK profiles of lurasidone metabolites in serum (ID-14283, ID-14326, ID-11614, 
ID-20219, and ID-20220) and urine (ID-14283, ID-14326, and ID-11614) in this subject 
population. The potential effects of gender on the PK of lurasidone injectable suspension and its 
metabolites will also be evaluated when applicable. 
A study schematic is presented in Figure 1. Details of the study assessments and other 
procedures to be performed at each visit are presented in Table 2, Schedule of Assessments, and 
Section 10, Study Assessments. The maximum duration for study participation for each subject 
will be up to approximately 96 days. If necessary, subjects may return to the clinic at any time 
for an unscheduled visit. 
Figure 1: 
Study Schematic 
 
a Eligible subjects must be washed out/tapered off of their current antipsychotic medications 5 to 6 half-lives prior to 
Day -8 (may begin as early as Day -19). Subjects are required to be inpatient from Day -12 to Day 15 (for 
treatment and observation) and Day 29 to Day 33 (for restabilization to previous medications). Subjects may 
remain inpatient up to Day 33 (at the Investigator’s discretion). 
b Subjects will receive 2 oral lurasidone 80 mg doses (Days -7 and -6) and be assessed for safety and tolerability for 
5 days (Days –5 to -1) and to allow appropriate time to washout of the oral lurasidone dose. 
c Randomization occurs on Day 1. Cohort 1 will receive a single lurasidone injectable suspension dose of 30 mg or a 
single placebo injection dose; thereafter, single lurasidone injectable suspension doses of 75, 150, 300, and 450 mg 
may be administered (cohorts 2-5). 
d Subjects will be monitored for safety after the single lurasidone injectable suspension or placebo injection dose 
until Day 29. Subjects may be discharged on Day 15 at the Investigator’s discretion. 
e Subjects will restart prior medications (including antipsychotics) on Day 29 under observation of clinical site staff. 
Subjects with schizophrenia who provide informed consent to participate in the study will 
undergo screening procedures and assessments between Days -35 to -13 to determine study 
eligibility. 


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Eligible subjects will be washed out/tapered off of their current antipsychotic medications over 
5 to 6 half-lives prior to Day -8 (may begin Day -19). Subjects will be monitored for safety 
during tapering/washout. Subjects will be admitted to the clinical site on Day -12 and are 
required to be inpatient until Day 15. 
Subjects will receive oral lurasidone 80 mg tablets on Day -7 and Day -6 (one dose per day), and 
be monitored for 5 days to ensure the subject is able to tolerate lurasidone (ie, absence of 
moderate adverse events). Subjects who tolerate dosing with oral lurasidone 80 mg will be 
eligible for randomization to receive a single lurasidone injectable suspension or placebo 
injection on Day 1. 
Subjects who are discharged after Day 15 will check into the clinical site again on Days 22 and 
29 for scheduled assessments. Subjects will follow protocol procedures to remain in-clinic 
through Day 33 as they restart their prior medications (including antipsychotics), under 
observation of the Investigator/clinical site staff (ie, restabilization period). 
Subjects who remained in-clinic through Day 29 will remain inpatient through Day 33 as they 
restart their prior medications (including antipsychotics) under observation of the 
Investigator/clinical site staff (ie, restabilization period). 
The restabilization period may be longer and subjects may remain in-clinic, as deemed necessary 
by the Investigator. 
Subjects who discontinue the study prior to Day 29 will undergo assessments scheduled for 
Day 29 at the time of discontinuation (see Table 2). Subjects who discontinue the study after 
Day 29 but prior to Day 61 will undergo assessments scheduled for Day 61 at the time of 
discontinuation (see Table 2). 
Subjects who complete the study per protocol will return to the clinic for a follow-up safety 
assessment on Day 61 (± 2). 
6.2. 
Treatment Assignment and Blinding 
6.2.1. 
Treatment Assignment 
The treatment schedule will be generated by a non-study biostatistician. 
For each cohort, the randomization number will be sequentially assigned as subjects qualify for 
the study. Once 8 subjects per cohort are dosed, alternate subjects who are not needed to 
complete enrollment of a cohort will be discharged following reintroduction of their prior 
medication if they are clinically stable (in the Investigator’s opinion). 
Once a randomization number has been assigned, it cannot be reused. 
Prior to dosing, all eligible subjects will be given a randomization number that assigns them to 
one of the two treatments. Randomization numbers will be assigned sequentially in the order the 
subject became eligible to participate in the study. The treatment schedule, a list consisting of the 
randomization numbers and their corresponding treatment assignment will be generated 
according to appropriate standard operating procedure(s). 
Subjects will receive single oral lurasidone 80 mg doses on Days -7 and -6, and be monitored for 
5 days to ensure the subject is able to tolerate lurasidone (ie, absence of moderate adverse 


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events). Subjects who tolerate dosing with oral lurasidone 80 mg will be eligible for 
randomization on Day 1. 
The study is planned to include up to 5 cohorts. A total of 8 subjects (6 active and 2 placebo) will 
be dosed in each cohort. Lurasidone injectable suspension dosing will be initiated at 30 mg given 
as an intramuscular (IM) injection at the ventrogluteal site. Subsequent cohorts are planned to be 
dosed at 75, 150, 300, and 450 mg IM at the ventrogluteal site. Dose strengths after the first dose 
level may be modified based on safety assessments and exposure to lurasidone injectable 
suspension. 
All 5 planned dose cohorts may not be used, depending on the dose escalation strategy 
employed. Additional cohorts may be included in this study, as necessary, and determined 
following a review of safety and exposure of lurasidone injectable suspension. Planned dose 
levels may be modified or repeated based on the overall safety profile of the current and/or 
previous cohorts. 
For Cohort 1, a sentinel group of 2 subjects will be dosed in a 1:1 ratio (lurasidone injection: 
placebo). A 7-day clinical assessment of safety and tolerability for the sentinel subjects will be 
made by the Investigator (including AEs, vital signs, and other clinically relevant findings), the 
remaining 6 subjects will be randomized in a 5:1 ratio (active: placebo). A sentinel group may 
not be required for future dose cohorts. 
If less than 6 subjects in a cohort complete through Day 29, additional subjects will be enrolled 
and randomized in a 1:1 ratio (active: placebo) until at least 6 subjects have completed the cohort. 
If additional subjects need to be enrolled in a cohort, up to 6 additional randomization numbers 
will be provided in a 1:1 ratio.  
6.2.2. 
Blinding 
This is a double-blind study. 
All study drug (active or placebo) will be dispensed according to the randomization schedule 
supplied by the Sponsor or its representative, using a method that will assure that subjects and 
blinded study site personnel remain blinded to the treatment (ie, active or placebo) being 
administered. 
Provided doses will be clearly labeled with a unique subject identifier and verified during 
preparation and at the time of administration to mitigate any possibility of dosing/randomization 
error. 
During the conduct of the cohorts, in order to maintain the blind during the time of study drug 
administration, up until a safety review of AEs and other safety data for a cohort is conducted, an 
unblinded clinical site pharmacist/nurse will dispense study drug in a manner that will protect the 
blind upon administration. All study drug (lurasidone injectable suspension or placebo) will be 
dispensed according to the randomization schedule supplied by the Sponsor or its representative, 
using a written study drug dispensing procedure that will assure that subjects remain blinded to 
the treatment being administered. 
Subjects, Investigator staff, persons performing the assessments, clinical operations personnel, 
data analysts, and personnel at clinical laboratories will remain blind to the identity of the 
treatment from the time of randomization until database lock and unblinding, with the exception 


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of the documented safety review process, using the following methods; (1) randomization data 
are kept strictly confidential (eg, sealed envelopes kept in a locked filing cabinet or placed in a 
safe) until the time of unblinding, and will not be accessible by anyone else involved in the study 
with the following exceptions: bioanalytical lab personnel involved in the analysis of PK 
samples, safety data review team members involved in regular review of safety data when it is 
determined that data need to be unblinded, (2) the identity of the treatments will be concealed by 
the use of study drugs that are all identical in packaging, labeling, schedule of administration, 
administration, and appearance; (3) subjects will be dosed by an unblinded site staff member 
who is not part of the study team and will not conduct any other study related procedures. 
Preliminary PK concentration data transfer from the bioanalytical lab to the Sponsor’s 
bioanalytical manager and from the Sponsor’s bioanalytical manager to the PK scientist (for PK 
analysis) for each cohort safety review can only be handled with dummy IDs for study subjects. 
Final PK concentration data transfer can only be performed after the clinical database lock. 
Treatment assignments for a particular cohort may be unblinded during a safety review meeting 
but only after a blinded review of the safety data has been completed. 
Potentially unblinding laboratory results (prolactin) will be reviewed by an unblinded medical 
monitor and be blinded to the Subjects, site staff, and clinical team, as described in the study 
Medical Monitoring Plan. Results reaching pre-specified criteria will be provided to sponsor 
and SRT. 
6.2.3. 
Emergency Unblinding Procedures 
Subject specific unblinding information (eg, individual envelopes) will be generated and stored 
in secured area in a tamper evident container. The blinded randomization information is to be 
broken only in an emergency when knowledge of such treatment may have an impact on further 
treatment decisions or aid in the emergency treatment of the subject. Every effort must be made 
to contact the Medical Monitor (Table 1) prior to any unblinding of the study drug. The 
circumstances that lead to the unblinding of treatment assignment are to be promptly 
communicated via telephone and in writing to the Medical Monitor. Any subject for whom the 
blind is broken should undergo final evaluation procedures, in accordance with the follow-up 
visit on Day 61 (± 2) as described in Section 10.5.5. 
6.3. 
Rationale 
6.3.1. 
Rationale for the Study Design 
The SAD study design is appropriate for a first-in-human evaluation of the safety, tolerability, 
and PK of lurasidone injectable suspension. 
6.3.2. 
Rationale for the Dosages 
Dosing for the lurasidone injectable suspension formulation is based on the amount in mg of 
lurasidone present at the injection site following IM administration, which was ~60 mg at the 
lowest dose of 7.5 mg/kg in the dog. There was no no-observed-adverse effect level determined 
in the dog; therefore a 2-fold reduction in the amount of lurasidone at the injection site was 
recommended, which is equal to 30 mg. At the clinical formulation’s fixed concentration of 
150 mg/mL, this dose will be an injection volume of 0.2 mL. 


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A 2-fold reduction is considered appropriate because the primary finding of granuloma is 
common following IM administration of an irritating substance. Clinicians are familiar with 
appropriate monitoring. This finding is reversible and non-lethal. The pharmacology of 
lurasidone is well known, and systemic findings in humans have been characterized over a range 
of serum concentrations. 
After the lurasidone injectable suspension starting dose of 30 mg, dose escalation will be as 
follows: 75, 150, 300, 450 mg for a single IM injection. A 6 week monitoring period for adverse 
events will be employed in this study. In animals, the injection site findings were apparent within 
1 week and findings persisted for an additional week before beginning to resolve. Therefore, if 
no injection site findings are seen within 2 weeks and no other stopping criteria are met, dose 
escalation may proceed. 
Projection of PK following each cohort indicates that Cmax will not exceed 348 ng/mL. This 
value is the Cmax at 400 mg orally, which is the MTD (Study D1050217, Day 6). It is unlikely 
that IM administration will exceed this concentration as the depot will absorb more slowly than 
following oral administration. Therefore, routine safety monitoring will be utilized to determine 
stopping criteria. 
In order to ensure subjects who are unable to tolerate lurasidone do not receive the lurasidone 
injectable suspension formulation, subjects will be evaluated for tolerability after administration 
of oral lurasidone 80 mg for 2 days (ie, two doses) prior to lurasidone injectable suspension 
administration. 
The oral lurasidone 80 mg dose was previously established as the maximum tolerated dose 
(MTD) in healthy subjects. In subjects with schizophrenia, an oral lurasidone dose of 
400 mg/day was previously established as the MTD. 
6.3.3. 
Rationale for the Study Population 
The subject population includes males and females ranging from 18 to 65 years of age, and in 
accord with standard practice guidelines, will be required to have a diagnosis of schizophrenia 
(by DSM-IV-TR). 
6.4. 
Prevention of Missing Data 
In an effort to minimize the number of subjects who withdraw consent prior to study completion, 
the number of visits and assessments has been limited to those required to collect the information 
needed to address the objectives of the study. Evaluation of safety and tolerability is essential for 
this study population, therefore, at the Investigator’s discretion, subjects may be inpatient during 
the washout/taper period as well as after the treatment/observation period. Obtaining PK samples 
postdose is an essential component of the study; therefore, subjects will remain in the clinic for 
the duration of the blood samples collection for serum PK assessment, and a concerted effort by 
the clinical site will be made to enroll and randomize subjects with good venous access. In 
addition, every effort will be made to have subjects complete follow-up safety contact. 
Refer to Section 14.3.9 for statistical considerations related to missing data. 


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7. 
SELECTION OF SUBJECTS 
7.1. 
Subject Inclusion Criteria 
Subjects must meet all of the following criteria for inclusion in the study: 
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. 
2. 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. 
4. Subject has a Body Mass Index (BMI) greater than or equal to 19.5 and less than or equal 
to 38 kg/m2. 
5. Subject does not have clinically relevant abnormal laboratory values per Investigator 
discretion. 
6. Subject does not have clinically relevant findings from vital signs measurements per 
Investigator discretion. 
7. 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 (see 
Section 9.6). 
• 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. 


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8. 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. 
9. Subject is able and willing to remain off of prior antipsychotic medication until the 
protocol-specified restabilization period. 
10. 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 
needed. 
7.2. 
Subject Exclusion Criteria 
The subjects who meet any of the following criteria will be excluded in the study. 
1. 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. 
2. Subject has known or suspected carcinoma. 
3. Subject has known presence or history of renal or hepatic insufficiency. 
4. 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. 
5. 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 of the following: heart rate 
(HR) > 100 bpm, QRS > 120 msec, QTcF > 450 msec, or PR > 220 msec. 
6. Subject has known history of a severe reaction to a previous antipsychotic (in the 
Investigator’s opinion), including up to 80 mg/day of oral lurasidone. 
7. Subject has a history of drug-dependence as per DSM-IV-TR criteria during the 
six month period immediately prior to study entry.  
8. Subject has known or suspected excessive alcohol consumption, (exceeding more than 
4 drinks on any single day or more than 14 drinks per week; 1 drink = 5 ounces of wine 
or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of the screening visit 
or a positive urine alcohol test at screening. 
9. Subject answers “yes” to “Suicidal Ideation” Items 4 or 5 on the C-SSRS at screening (in 
the past 1 month [30 days]) or at any point prior to randomization or history of suicidal 
behavior within the last two years. 
10. Subject has significant orthostatic hypotension at screening (ie, a drop in systolic blood 
pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or 
more on standing). 


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11. Subject has presence or history (within the last year) of a medical or surgical condition 
that might interfere with the absorption, metabolism, or excretion of administered 
Lurasidone injectable suspension. 
12. Subject has a history of epilepsy or risk of having seizures. 
13. Subject has a positive urine alcohol at screening or on Day -12. 
14. Subject has positive test results within 28 days prior to the start of the study for: 
a. Human immunodeficiency virus (HIV). 
b. Hepatitis B surface antigen and Hepatitis C antibody. 
c. Urine drug test (marijuana, amphetamines, barbiturates, cocaine, opiates, 
benzodiazepines, methadone, or other drugs of abuse). However, a positive test for 
benzodiazepines may not result in exclusion of subjects if the Investigator determines 
that the use of a prescription benzodiazepine is appropriate. 
d. Serum β-human chorionic gonadotropin (HCG) consistent with pregnancy 
(females only). 
15. Subject has used of any inhibitor or inducer of CYP3A4 taken within 28 days prior to 
drug administration and until discharge. 
16. Subject has have used of concomitant medications that prolong the QT/QTc interval 
within 28 days prior to Day -12 through follow-up. 
17. Subject has received depot neuroleptics unless the last injection was at least one 
treatment cycle before Day -12. 
18. Subject has poor peripheral venous access or does not tolerate venipuncture that would 
cause difficulty for collecting blood samples. 
19. Subject has experienced significant blood loss (≥ 473 mL) or donated blood within 
30 days prior to screening, or intends to donate plasma or blood or undergo elective 
surgery during study participation or within 30 days after the last study visit. 
20. Subject has a prolactin concentration greater than or equal to 200 ng/mL at screening. 
21. Subject is unwilling to abstain from vigorous exercise from Day -12 until study 
discharge. 
22. Subjects has a significant risk of violent behavior or a significant risk of suicidal behavior 
based on history or in the PI’s judgment OR is considered by the Investigator to be at 
imminent risk of suicide or injury to self, others, or property. 
23. Subject has a history of allergic reaction (clinically relevant history of drug 
hypersensitivity) or has a known or suspected sensitivity to any substance that is 
contained in the study drug or to Polysorbate 80, sodium chloride, or sodium phosphate. 
24. Subject requires treatment with a drug that consistently prolongs the QTc interval (see 
Section 22, Appendix IV). 
25. Subject is currently participating, or has participated in a study with an investigational or 
marketed compound or device within 30 days prior to signing the informed consent, or 


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has participated in 3 or more studies within 18 months prior to signing the informed 
consent. 
26. Subject is a staff member or the relative of a staff member. 
27. Subject, in the Investigator’s opinion, is unsuitable in any other way to participate in the 
study. 
28. Subject is unable or unwilling to comply with study instructions, procedures or 
restrictions. 
8. 
STUDY DRUG MATERIALS AND MANAGEMENT 
8.1. 
Description of Study Drug 
Reference Therapy Lurasidone 80 mg will be provided as film-coated tablet formulation as 
commercially available Latuda 80 mg tablets. 
Lurasidone injectable suspension will be provided as sterile white to off-white aqueous 
suspension (150 mg/mL lurasidone) for intramuscular injection. The suspension will be 
packaged in clear USP Type I glass vials with rubber stoppers. 
A starting dose of 30 mg (0.2 mL lurasidone injectable suspension) will be given. Lurasidone 
injectable suspension will be administered to subjects using syringe and gauge 22-23 needle. The 
syringe will be covered to maintain blinding. 
Doses of 75, 150, 300, and 450 mg may be administered (ie, cohorts 2-5). 
Placebo injection will be provided as sterile clear aqueous solution for intramuscular injection. 
The solution will be packaged in clear USP Type I glass vials with rubber stoppers. 
Placebo for lurasidone injectable suspension will be administered to subjects using syringe and 
gauge 22-23 needle. The syringe will be covered to maintain blinding. 


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Table 5: 
Investigational Product 
Attribute 
Investigational Product 
Product name 
Lurasidone Injectable 
Suspension 150 mg/mL 
Placebo Injection 150 mg/mL 
Dosage form 
Injectable suspension 
Injectable solution 
Route of administration 
Intramuscular injection 
Intramuscular injection 
Physical description 
Sterile white to off-white 
aqueous suspension 
Sterile clear aqueous solution 
Excipients 
Polysorbate 80, sodium chloride, monobasic sodium phosphate and 
dibasic sodium phosphate, and Water for Injection 
8.2. 
Study Drug Packaging and Labeling 
8.2.1. 
Package Description 
Reference therapy Lurasidone 80 mg film-coated tablets will be packaged in HDPE bottles as 
market product of Latuda®. 
Lurasidone injectable suspension will be packaged, with pre-filled volume of 1.25 mL, in a clear 
USP Type I glass vials with rubber stoppers and sealed. The vials will be stored in a carton with 
dividers. 
Placebo for Lurasidone injectable suspension will be packaged with pre-filled volume of 
1.25 mL, in a clear USP Type I glass vials with rubber stoppers and sealed. The vials will be 
stored in a carton with dividers. 
8.2.2. 
Labeling Description 
All labeling and packaging for study drug will be based on all applicable regulatory requirements 
described in the United States (US) Code of Federal Regulations (CFR), CRF21, Part 312.6. 
Label text may include, but is not limited to, the following information: 
• Protocol number 
• Sponsor’s name and address 
• Contents (eg number of tablets, strength) 
• Instructions for use and storage 
• Lot number 
• Unique medication number (if needed) 
8.3. 
Study Drug Storage 
Lurasidone oral tablets are to be stored at 25°C (77°F); excursions permitted to 15° - 30°C (59° F 
to 86°F). 
Lurasidone injectable suspension and placebo for injection are to be stored at 20-25°C (68-77°F). 


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8.4. 
Dispensing of Study Drug 
Unblinded clinical site pharmacist will prepare and quality check each injection dose for each 
subject per provided pharmacy manual, randomization schedule, and other applicable local 
regulations as set forth in the protocol. The unblinded site pharmacist will be trained with the 
pharmacy manual. 
8.5. 
Study Drug Accountability 
The Investigator or designee is responsible for storing the drug in a secure location and for 
maintaining adequate records of drug receipt and disposition that includes the dates, quantity, 
and use for purposes or by subjects. If the study is stopped for any reason or completed, all 
unused supplies of drug will be returned to the Sponsor, unless other instructions are provided in 
writing by Sponsor/CRO. 
Upon receipt of study drug, the Investigator or designee will inventory and verify receipt of 
supplies. The site will perform an acknowledgement of receipt via site established process and 
per requirements outlined in the pharmacy manual confirming the date of receipt, inventory and 
condition of study drug received into site source document. 
The Investigator or designee will maintain the inventory for accountability, including study drug 
dispensation, return and availability of study drug received. Established site standards and 
instructions outlined in the pharmacy manual will provide instruction for the accountability of 
the study drug at the clinical site. 
The drug will not be dispensed to any person who is not a study subject under this protocol. 
8.6. 
Study Drug Handling and Disposal 
The Investigator or designee on an ongoing basis must maintain a drug inventory record of 
supplied, received, dispensed, and returned medication. The Investigator or designee is required 
to return all unused study drug to the Sponsor or designee, or destroyed as instructed in writing 
from Sponsor. The Investigator or designee is required to maintain copies of medication shipping 
receipts, drug accountability records, and records of return or final disposal of the study drug in 
accordance with local regulatory requirements. 


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9. 
TREATMENT OF SUBJECTS 
9.1. 
Study Drug 
Lurasidone 80 mg will be provided as the commercially available oral tablet formulation 
(Latuda®). 
Lurasidone and placebo for injection will be supplied as defined in Section 8.2. 
Subjects will receive oral lurasidone 80 mg on Days -7 and -6, and be monitored for 5 days to 
ensure the subject is able to tolerate lurasidone (ie, absence of moderate adverse events). 
Subjects who tolerate dosing with oral lurasidone 80 mg will receive lurasidone or placebo 
injection on Day 1. 
9.2. 
Dose Escalation/Safety Cohort Review 
After each cohort, a review of safety data (eg, AE [including potential psychotic symptoms and 
behavior], vital signs, laboratory data, standard 12-lead ECG, etc.) and lurasidone injectable 
suspension exposure data for all subjects (or at least 5 lurasidone and 1 placebo subjects 
completed) in each cohort will be performed. Subsequent dosing at the next dose level/cohort 
will not occur until safety and exposure data (from at least 14 days after the single lurasidone 
injectable suspension dose) have been evaluated by the Safety Review Team (SRT). The SRT 
consists of the PI, the Sponsor’s Responsible Physician or designee, the Sponsor’s Project 
Medical Lead, the Sponsor’s Head of Translational Medicine and Early Development team or 
designee and the Medical Monitor. The SRT will also determine if sentinel subject dosing is 
required for study cohorts after Cohort 1. 
The decision to proceed to the next dose level/cohort and at what dose level will also be made by 
the voting members of the SRT, based on a review of the clinical observations, laboratory data, 
and exposure data, and will require a majority agreement concerning acceptable safety and 
tolerability of lurasidone injectable suspension. Based on these safety reviews, a more 
conservative dose escalation may be used that will be less than the planned dose escalation, or 
subsequent cohorts may repeat a dose level or de-escalate. For each cohort, the SRT will monitor 
and review AE and exposure data 14 days and 28 days after the injection dose. 
Treatment assignments for a particular cohort may be unblinded during a safety review meeting, 
but only after a blinded review of the safety data has been completed. PK exposure data will be 
utilized in the safety review; thus, it will be necessary for the bioanalytical laboratory to be 
unblinded to treatment assignment for the subjects. 
9.3. 
Determination of the MID and MTD 
The MID will be defined as the dose of Lurasidone injectable suspension at which dose limiting 
toxicity (DLT) occurs. Dose-limiting toxicity is indicated by the occurrence of intolerable AEs, 
which are not fully defined a priori, but will be determined from the study data at the SRT 
meetings. The following criteria will be used as a guide: 


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• If 50% or more of the subjects receiving study drug have either multiple moderate 
AEs and/or a severe AE possibly related to study drug as determined by the SRT – 
MID may have been reached, and safety data will be unblinded. 
• If more than one subject but less than 50% of the subjects receiving study drug have 
either multiple moderate AEs and/or a severe AE possibly related to study drug as 
determined by the SRT – a dose level/cohort may be repeated or a modified 
escalation may be employed, and safety data of the subject(s) in question will be 
unblinded. 
The SRT may decide to stop dose escalation, repeat a dose, or de-escalate if the number, 
severity, or type of AEs indicates that higher doses would not be tolerated. In addition, the 
following stopping criteria for dose-escalation will also be used to assess whether to proceed to a 
higher dose level in the next cohort. Dose escalation will not occur, although a dose cohort may 
be repeated or de-escalate if any of the following criteria are met: 
• Adverse Events 
- A SAE associated with the use of the study drug with a reasonable possibility that 
the event may have been caused by the study drug occurs in any subject on 
active drug. 
• Cardiac Parameters 
- A confirmed value of QTcF interval > 500 ms or > 60 ms change from baseline, 
based on cardiologist over read ECGs occurs in any 2 subjects on active drug. 
• Hepatic Parameters 
- Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase 
[AST], or total bilirubin [TBL]) > 3 x upper limit of normal (ULN) occurs in any 
3 subjects on active drug. 
- Any one of Hy’s law criteria are met for any subject on active drug. 
- ALT or AST > 8 x ULN. 
- ALT or AST > 5 x ULN for more than 2 weeks. 
- ALT or AST > 3 x ULN and (TBL > 2 x ULN or international normalized ratio 
[INR] > 1.5). 
- ALT or AST > 3 x ULN with the appearance of fatigue, nausea, vomiting, right 
upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%). 


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• Injection site reactions will be assessed for severity according to each of the 
following categories (per the Investigator’s judgement): 
Local Reaction to 
Injectable Product  
Mild (Grade 1) 
Moderate 
(Grade 2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Pain 
Does not interfere 
with activity 
Repeated use of 
non-narcotic pain 
reliever > 24 hours 
or interferes with 
activity 
Any use of 
narcotic pain 
reliever or 
prevents daily 
activity 
Emergency room 
(ER) visit or 
hospitalization 
Tenderness  
Mild discomfort to 
touch 
Discomfort with 
movement 
Significant 
discomfort at rest 
ER visit or 
hospitalization 
Erythema/Redness 
2.5 – 5 cm 
5.1 – 10 cm 
> 10 cm 
Necrosis or 
exfoliative dermatitis 
Induration/Swelling 
2.5 – 5 cm and does 
not interfere with 
activity 
5.1 – 10 cm or 
interferes with 
activity 
> 10 cm or 
prevents daily 
activity 
Necrosis 
Reference: FDA Guidance for Industry “Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers 
Enrolled in Preventive Vaccine Clinical Trials,” 2007. 
Adverse events, including SAEs, which start prior to study drug injection, will not be considered 
for stopping criteria. 
Once a safety stopping criterion is reached, the study will not escalate beyond that dose level. If 
none of the stopping criterion has been attained, the study will proceed to the next higher dose 
level. Dosing of an additional cohort or cohorts at a dose between the identified MID and the 
highest dose below the MID may be conducted. The highest tolerated dose below the MID will 
be defined as the MTD for a single lurasidone injectable suspension dose. 
If the MTD is not established, additional dose cohorts may be commenced until the MTD is 
reached. 
9.4. 
Treatment Compliance 
This is a single-dose study. Study drug will be administered at the clinical site. The date and time 
of study drug administration will be recorded. 
9.5. 
Prior and Concomitant Medications 
The following information on all concomitant medication administered will be recorded on the 
CRF and will include medication name, dose, dose unit, frequency, route, start date, stop date, 
and indication. Any medication or non-pharmacological therapy that is taken by or administered 
to the subject at any point during the course of this study must be recorded in the eCRF. 
Information on the format and version of coding dictionary is provided in the Data Management 
Plan. All medications will be coded using WHO-DD. 


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9.5.1. 
Prior Medications 
All prior antidepressants and mood stabilizers (eg, lithium, divalproex/valproic acid, 
carbamazepine) must be discontinued as tolerated and clinically appropriate starting on Day -12. 
All other psychotropic medication (except as described in Section 9.5.3), including antipsychotic 
medication, must be discontinued as tolerated and clinically appropriate starting on Day -12 in a 
manner that is consistent with labeling recommendations and conventional medical practice. 
These prior medications will not be allowed until subjects have completed Day 30. 
Initiation of new psychotherapeutic interventions (eg, a new course of psychotherapy) will not be 
permitted during the study through the restabilization period. Subjects who have participated in 
ongoing psychotherapy treatment for at least 12 weeks prior to screening will be permitted to 
continue this treatment during the study. 
Additional medication use as specified in the exclusion criteria is prohibited prior to the study. 
9.5.2. 
Concomitant Nonpsychotropic Medications 
Non-psychotropic medications used to treat mild, chronic medical conditions may be used during 
Screening and after assignment of a subject number, if the dose and regimen have been stable 
(± 25%) for at least 30 days prior to Screening. The concomitant medication dose may change as 
needed (or be discontinued) after a subject number is assigned. In addition, use of 
nonprescription pain medications are allowed during all phases of the study provided these 
medications do not have a propensity for psychotropic effects and do not interfere with the 
evaluation of study medication. Medications for short-term treatment of a medical condition (no 
more than 10 days) are allowed with consultation with the Medical Monitor provided that the 
medications are not drugs that prolong the QT/QTc interval or CYP3A4 inhibitors or inducers 
(see Section 22, Appendix IV and Section 23, Appendix V, respectively). 
9.5.3. 
Concomitant Psychotropic Medications 
During the wash-out, treatment and post-treatment periods, treatment with benztropine (up to 
6 mg/day) will be permitted as rescue medication and as treatment for movement disorders. In 
cases where benztropine is not available or a subject has had an inadequate response or 
intolerability to benztropine treatment, the following medications may be used to treat acute 
EPS: biperiden (up to 16 mg/day) or trihexyphenidyl (up to 15 mg/day) or diphenhydramine (up 
to 100 mg/day). Treatment with amantadine (up to 300 mg/day) will be permitted as needed for 
akathisia. Medications used to treat movement disorders should not be given prophylactically. 
Medications used for movement disorders should be tapered and discontinued prior to a subject 
number is assigned but may be reinstituted if symptoms emerge. 
In situations where anticholinergic agents or any other agents that may cause sedation are 
administered, these should be taken at the same time each day and should not be taken within 
12 hours of scheduled assessments. When the specified drugs are not available, similar drugs at 
equivalent dosages will be substituted in consultation with the Medical Monitor. Concomitant 
use of lorazepam, temazepam, or zolpidem is permitted with the following restrictions: 
lorazepam is permitted for clinically significant anxiety/agitation or as a sedative/hypnotic up to 
a maximum daily dose of 6 mg/day. Intramuscular lorazepam is permitted up to 4 mg/day for 
acute anxiety/agitation, as clinically indicated. Lorazepam should be used sparingly, when 


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clinically required, per Investigator judgment. Zolpidem (≤ 10 mg in any 24-hour period) and 
temazepam (≤ 30 mg in any 24-hour period) may be administered, as needed, as 
sedatives/hypnotics. Hypnotic agents should be administered no more than once nightly and 
should not be used in combination. 
Medications used for the as-needed treatment of anxiety/agitation and insomnia (eg, lorazepam 
and zolpidem) should not be used in close temporal proximity (defined as administration within 
2 hours of each other). When lorazepam or zolpidem or other specified medications are not 
available, another similar agent at equivalent doses will be permitted as specified by the Medical 
Monitor. Opiates may be allowed in rare cases for a limited period of time with prior 
authorization from the Medical Monitor. Subjects who require treatment with one or more of the 
medications listed in Section 22, Appendix IV or Section 23, Appendix V should be excluded or 
discontinued (as appropriate) from the study. Since these lists of drugs are not comprehensive, 
Investigators should use medical judgment when a subject presents with a medication not on the 
list or consult with the Medical Monitor for clarification. 
9.5.4. 
Prohibited Medications 
In accordance with the approved product labeling for Latuda (see approved product labeling), 
lurasidone should not be used concomitantly with a strong CYP3A4 inhibitor (eg, ketoconazole, 
clarithromycin, ritonavir, voriconazole, mibefradil). Lurasidone should not be used 
concomitantly with a strong CYP3A4 inducer (eg, rifampin, avasimibe, St. John’s wort, 
phenytoin, carbamazepine). A list of strong CYP3A4 inhibitors and inducers included in 
Section 23, Appendix V). 
The use of herbal supplements or other complementary or alternative medications during the trial 
is not permitted. 
9.6. 
Contraception Requirements 
Female Subjects 
1. Female subject must be using and willing to continue using a highly effective form of 
birth control for at least 28 days prior to administration of the first dose of study drug, 
during the treatment period, and 2 months (60 days) after completion or premature 
discontinuation from the study drug. Highly effective forms of contraception include: 
• Combined estrogen and progestogen containing hormonal contraception (oral, 
intravaginal or transdermal) associated with inhibition of ovulation. 
• Progestogen-only hormonal contraception (oral, injectable, implantable) associated 
with inhibition of ovulation. 
• Intrauterine device. 
• Intrauterine hormone-releasing system. 
• Bilateral tubal occlusion. 
• Bilateral tubal ligation. 


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• Male sterilization (with the appropriate post-vasectomy documentation of the absence 
of sperm in the ejaculate). For female subjects on the study, the vasectomized male 
partner should be the sole partner for that subject. 
• True abstinence: When this is in line with the preferred and usual lifestyle of the 
subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation 
methods) and withdrawal are not acceptable methods of contraception. 
Women using hormonal contraception must use an additional form of contraception (eg, 
condom with spermicide). 
2. A 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 
2 months after completion or premature discontinuation from the study drug. 
Highly effective methods of birth control are listed above in number 1). 
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 
Male subject with female partner(s) of childbearing potential must ensure that his partner(s) uses 
the methods of contraception as outlined for female subjects above. 
9.7. 
Guidance for Overdose 
Refer to the approved product labeling for guidance for overdose with lurasidone oral tablets. 
Overdose has not been evaluated for lurasidone injectable suspension. 


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9.8. 
Dietary Restrictions 
Subjects will fast for at least 8 hours before dosing on Day -7 and Day -6. Subjects will fast for 
4 hours after dosing on Day -7 and Day -6. 
On Days -7 and -6, standard breakfast (minimum 350 calories) will be served 30 minutes prior to 
the planned dosing time. 
Dosing of lurasidone 80 mg orally will take place 30 minutes after the start of breakfast. Subjects 
will receive dose administration at approximately the same time on each day of dosing during the 
study. 
Lurasidone 80 mg will be administered with approximately 240-mL water on Days -7 and -6. 
Water intake is restricted for one hour before and two hours after dose administration; after 
which water will be allowed ad libitum. 
Lunch will be provided ≥ 4 hours postdose on Days -7, -6 and 1. Standard meals will be provided 
during the inpatient periods and outpatient clinic return visits when applicable. 
10. 
STUDY ASSESSMENTS 
A study schematic is presented in Figure 1. A summary of assessments to be conducted at each 
visit is presented in Table 2. 
Assessments will be conducted within the time frames specified. All times are relative to the 
time of dosing for individual subjects unless otherwise specified. If no time window is specified, 
assessments should occur ± 1 hour of schedule. 
10.1. 
Demographics and Baseline Characteristics 
Subject self-report will be acceptable for listing all prior and concomitant medication use, 
demographics, medical history, psychiatric history, and evaluation for inclusion/exclusion except 
where specific protocol procedures are mandated to ensure appropriate enrollment (eg, certain 
baseline laboratory values). All medications taken within the 30 days before screening will be 
recorded. 
Demographics (date of birth, sex, ethnicity, race), prior and current medications, and medical and 
psychiatric history will be collected. 
10.2. 
Safety Assessments 
The Investigator or appropriate designee will review results of safety assessments as they 
become available. The Sponsor must be kept fully informed of any clinically significant findings 
either at Screening or subsequently during study conduct through appropriate adverse event 
reporting and/or escalation to the Medical Monitor. Please also refer to the dose escalation 
stopping criteria Section 9.3). 


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10.2.1. 
Pretreatment Events and Adverse Events 
Pretreatment events will be recorded from the time informed consent is provided at screening 
until the time of first lurasidone oral tablet dose administration at Day -7. 
Adverse events will be collected for each subject from immediately after the first lurasidone oral 
tablet dose administration at Day -7 until the follow-up visit at Day 61 (± 2). 
Subjects should be queried in a non-leading manner, without specific prompting (eg, “Has there 
been any change in your health status since your last visit?”). See Section 11, Safety Reporting. 
AEs and SAEs will be monitored throughout the study at all visits. 
10.2.2. 
Clinical Laboratory Tests 
The clinical laboratory tests required by protocol are listed in Section 20, Appendix II. 
Blood and urine samples will be collected for clinical laboratory tests. All clinical laboratory 
tests will be performed locally. For clinical laboratory procedures, sampling, and shipping, the 
site will follow their standard procedures. All clinical laboratories will be College of American 
Pathologists and Clinical Laboratory Improvement Amendments (CLIA) (or equivalent) 
certified. 
Any point of care kits that are performed on site by study personnel rather than in a lab must be 
CLIA waived and the study center must possess a CLIA certificate of Waiver. 
A window of ± 10 minutes is allowed for clinical laboratory test sample collection. Samples will 
be obtained at the same time that other blood and urine samples are taken whenever possible. 
Serum Prolactin levels will be blinded, except at screening and Day 1. Investigator will be 
notified if prolactin concentrations are > 200 ng/mL 
10.2.3. 
Physical Examinations 
Complete physical examinations will be performed. Worsening or changes in findings will be 
recorded as pretreatment events (prior to dosing) or as adverse events (after dosing). 
10.2.4. 
Injection Site Assessments 
10.2.4.1. Investigator Injection Site Assessments 
The Investigator will assess the injection site using a rating of 1-4 on each of the 4 items (pain, 
tenderness, erythema/redness, and induration/swelling). A window of +1 minute is allowed for 
the immediately after injection timepoint, and a window of ± 5 minutes is allowed for the 6 and 
12 hour injection site assessments on Day 1. 
In addition subjects will be monitored for potential allergic reaction for 15 minutes after injection. 
A window of 0-5 minutes is allowed for this assessment. 
10.2.4.2. Subject Injection Site Assessments 
The subject will assess their injection site pain using a rating of 1-10 on a Likert scale (0 = no 
pain, 10 = worst pain). This will be completed prior to the Investigator’s injection site 


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assessment. A window of +1 minute is allowed for the immediately after injection timepoint, and 
a window of ± 5 minutes is allowed for the 6 and 12 hour injection site assessments on Day 1. 
10.2.5. 
Weight, Body Mass Index, and Height 
Weight and height should be measured in street clothing with no shoes. Body mass index (BMI) 
will be calculated by the site (see Section 24, Appendix VI for calculation and BMI table). 
10.2.6. 
Vital Signs 
Blood pressure (supine and standing), pulse rate (supine and standing), respiration rate, and body 
temperature will be measured. 
Supine blood pressure and pulse rate will be collected at the same time as 12-lead ECG (when 
12-lead ECG is collected for the same timepoint). A window of ± 10 minutes of scheduled time 
is allowed. After Cohort 1, scheduled timepoints for vital signs measurements may be changed 
based on observed tmax of Lurasidone injectable suspension and its metabolites. 
After lying supine for ≥ 5 minutes, systolic and diastolic blood pressures, respiratory rate, pulse 
rate, and oral temperature will be collected. Blood pressure and pulse rate will be taken again 
after standing for 2 to 4 minutes. The same arm should be used during each assessment of blood 
pressure and pulse rate throughout the study. 
If a subject develops symptoms consistent with orthostatic hypotension (light-headedness, 
dizziness, or changes in sensorium upon standing) at any point, his or her supine and standing 
blood pressure and pulse rate should be collected at that time in the manner described above. 
Vital signs will be obtained prior to clinical laboratory collection and performance of an ECG. 
10.2.7. 
12-Lead ECG 
All ECGs will be obtained in the supine position, after the subject has been resting supine for at 
least 5 minutes. ECGs will be 12-lead with a 10-second rhythm strip. ECGs should be obtained 
prior to drawing blood samples. All attempts should be made to use the same ECG recorder for 
all visits within individual subjects. ECGs will be centrally read at a core lab according to 
established quality assurance procedures for inter/intra reader variability. Refer to Section 19, 
Appendix I for additional information. 
A window of ± 15 minutes of scheduled time is allowed. After Cohort 1, scheduled timepoints 
may be changed based on observed tmax of Lurasidone injectable suspension and its metabolites. 
10.2.8. 
Columbia-Suicidality Severity Rating Scale (C-SSRS) 
The C-SSRS is a tool designed to systematically assess and track suicidal AEs (suicidal behavior 
and suicidal ideation) throughout the study. The strength of this suicide classification system is 
in its ability to comprehensively identify suicidal events while limiting the over-identification of 
suicidal behavior. The C-SSRS will be administered by a trained rater at the site. 
This study will utilize 2 versions of the C-SSRS. At the Screening visit, the Screening/Baseline 
version will be completed; for all subsequent visits, the “Since Last Visit” version of the C-SSRS 
will be administered. 


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Subjects who answer “yes” to “suicidal ideation” item 4 (active suicidal ideation with some 
intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and 
intent) on the C-SSRS assessment at Screening (in the past 1 month) are not eligible and must be 
referred to the Investigator for follow-up evaluation. 
Further information regarding administration of the C-SSRS, including rater training and 
certification as well as recording C-SSRS scores, will be provided in the Study Reference 
Manual. 
10.3. 
Pharmacokinetic Assessments 
Blood samples for serum PK assessment will be collected at predose and 2 hours after tablet 
administration, and at predose and multiple timepoints up to 1440 (± 48) hours after the injection 
dose. 
Validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods will be used 
for determination of lurasidone and metabolite concentrations. 
The detailed sample collection procedures are provided in Section 21, Appendix III for blood 
and urine sampling and sample handling guidelines. Blood and urine collection date and times 
(clock time) must be recorded. 
A window of ± 5 minutes of scheduled time (up to 8 hours postdose), and ± 10 minutes of 
scheduled time (from 12 hours postdose onward) is allowed. Blood sampling timepoints for PK 
assessment for subsequent cohorts may be modified based on serum concentration data from 
initial cohort(s). Evaluation of the relationship between the timing of below limit of 
quantification (BLQ) and the elimination half-life will be used to justify the revised blood 
sampling for PK and safety assessment schedule. 
For subjects receiving lurasidone injectable suspension treatments, all samples will be measured 
for lurasidone and its metabolites in serum (ID-14283, ID-14326, ID-11614, ID-20219 and 
ID-20220) and in urine (ID-14283, ID 14326, and ID-11614) after a single dose of lurasidone 
injectable suspension. For placebo subjects usually only a subset of serum and urine samples will 
be measured to confirm no dosing error, interference, or occurrence of contamination. 
Cmax, tmax, AUC0-last, and AUC0-inf for Lurasidone injectable suspension will be the primary PK 
parameters and all others will be secondary PK parameters. 
Dose proportionality of Lurasidone injectable suspension will be assessed using a power model 
for Cmax, AUC0-last, and AUC0-inf of Lurasidone injectable suspension with a formula of ln (PK 
parameter) = α + β⋅ln (dose level). 
The following PK parameters, determined by noncompartmental methods using Phoenix® 
WinNonlin® version 6.4 or higher, are based on the individual subject’s serum concentration 
data. 


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Serum Parameters 
Cmax 
 
Maximum observed serum concentration 
tmax 
Time of occurrence of serum Cmax 
Clast 
 
The last postdose quantifiable serum concentration 
tlast 
Time of the last postdose quantifiable serum concentration 
lz  
Elimination rate constant obtained from a linear regression of the natural log (ln) 
transformed concentrations versus time data in terminal phase. A minimum of 
3 points, clearly visible in the terminal phase, are required to calculate lz. 
t½  
Terminal elimination half-life, calculated as ln(2)/ lz. 
AUC0-last  
Area under the analyte concentration-time curve from time 0 (t0 = 0) to the last 
postdose quantifiable serum concentration calculated using the linear up log down 
trapezoidal method. 
,
0
)
t - t
)(
2
C
 
+
 
C
( 
  
AUC
   
1
-i
i
i
1
-i
k
1
=
i
=
last
∑
-
 
where Ci is the drug concentration at time ti, i = 1, 2, …, k. 
AUC0-∞ 
 
Area under the analyte concentration-time curve from 0 to infinity calculated by 
summing AUC0-last and the AUC extrapolated from tlast to infinity. 
.
  
   
0
0
z
last
last
C
 
+ 
AUC
  =
AUC
l
−
∞
−
 
If Clast / |lz| is greater than 30% of AUC0-∞, then AUC0-∞ was considered missing. 
CL/F 
Apparent clearance calculated as Dose/AUC0-∞ 
Vz/F 
Apparent volume of distribution calculated as Dose/AUC0-∞/λz 
MRCmax 
The ratio of metabolites (ID-14283, ID-14326, ID-11614, ID-20219, and 
ID-20220) Cmax (mCmax) to parent (lurasidone injectable suspension) Cmax (pCmax) 
calculated as: mCmax divided by pCmax 
MRAUC0-∞ The ratio of metabolites (ID-14283, ID-14326, ID-11614, ID-20219, and 
ID-20220) AUC0-∞ (mAUC) to parent (lurasidone injectable suspension) AUC0-∞ 
(pAUC) calculated as: mAUC divided by pAUC 


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Urine Parameters 
Ae0-144h 
The cumulative amount of the analyte excreted from time zero to 144 hours. The 
amount of the analyte excreted in the urine during a given collection interval is 
calculated as the product of the urinary volume and the urinary concentration. The 
cumulative amount of the analyte excreted during the time interval is calculated by 
summing the amounts excreted in all of the collection intervals between t1 and t2; 
nominal t1 holds the value 0 and nominal t2 holds the value 144, respectively. 
CLR 
Renal clearance for an analyte during the time interval t1 and t2 is calculated as: 
CLR = Aet1-t2/AUCt1-t2 
Fe 
Percent of administered analyte excreted unchanged in urine during the time 
interval t1 to t2 is calculated as: 
fe = (Aet1-t2/Dose)*100 
Remaining serum samples after PK analysis may also be used for the additional characterization 
and/or bioanalytical method development of putative metabolites of lurasidone injectable 
suspension and for other exploratory measurements, if needed. 
10.4. 
Pharmacodynamic Assessment (PANSS) 
The PANSS is an interview-based measure of the severity of psychopathology in adults with 
psychotic disorders. The measure is comprised of 30 items and 3 scales: the Positive subscale 
assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses 
emotional withdrawal, lack of motivation, and similar symptoms; and the General 
Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and 
disorientation. 
An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of 
progressively more severe symptoms, is used to score each item. Individual items are then 
summed to determine the total score. 
10.5. 
Study Visits and Assessments 
10.5.1. 
Days -35 to -13 (Screening) 
Subjects will be evaluated during the Screening period to determine their eligibility to enroll in 
the study. 
To determine subject eligibility, abnormal Screening clinical laboratory tests may only be 
repeated after discussion with the Medical Monitor. 
To determine subject eligibility, Screening ECG may only be repeated due to technical issues. 
The following study-related procedures will be performed at Screening: 
• Obtain Informed Consent. 
• Review Inclusion/Exclusion Criteria. 


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• Record Medical and Psychiatric History. 
• Record Demographics. 
• Perform Physical Examination. 
• Record Height. 
• Record Weight and BMI. 
• Obtain Vital Signs. 
• Perform 12-Lead ECG. 
• Collect Blood and Urine Samples for Clinical Laboratory Tests: 
- Hematology 
- Serum Chemistry 
- Urinalysis 
- Lipid Panel 
- Thyroid Panel 
- Coagulation Panel 
• Collect Blood Sample for Serum Prolactin. 
• Collect Blood Sample for Serology. 
• Collect Blood Sample for b-hCG Serum Pregnancy Test (female subjects). 
• Collect Urine Sample for: 
- Urine Drug Screen 
- Urine Alcohol Test 
• Administer C-SSRS (Screening/Baseline Version). 
• Administer PANSS. 
• Record Prior and Concomitant Medications. 
• Record Pretreatment Events. 
• Schedule Next Visit. 
10.5.2. 
Washout/Taper Period: Days -12 to -8 
Subjects are required to be inpatient for the washout/taper period. Subjects will be admitted to 
the clinical site on Day -12. Subjects may be admitted earlier, depending on the required washout 
for their current antipsychotic medications (ie, 5 to 6 half-lives prior to Day -8). 
10.5.2.1. Day -12 (Washout/Taper) 
The following study-related procedures will be performed: 


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• Admit Subject to Clinical Site. 
• Perform Physical Examination. 
• Obtain Vital Signs. 
• Perform 12-Lead ECG. 
• Collect Blood Sample for b-hCG Serum Pregnancy Test (female subjects). 
• Collect Urine Sample for: 
- Urine Drug Screen 
- Urine Alcohol Test 
• Begin washout/taper of psychotropic medications (may begin Day -19). 
• Provide Meals. 
• Record Concomitant Medications. 
• Record Pretreatment Events. 
10.5.2.2. Days -11 to -9 (Washout/Taper) 
The following study related procedures will be performed: 
• Awaken Subject. 
• Provide Meals. 
• Record Concomitant Medications. 
• Record Pretreatment Events. 
10.5.2.3. Day -8 (End of Washout/Taper Period) 
The following study related procedures will be performed: 
• Awaken Subject. 
• Provide Meals. 
• Review Inclusion/Exclusion Criteria. 
• Perform Physical Examination. 
• Record Weight and BMI. 
• Obtain Vital Signs. 
• Perform 12-Lead ECG. 
• Collect Blood and Urine Samples for Clinical Laboratory Tests: 
- Hematology 
- Serum Chemistry 
- Urinalysis 


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- Lipid Panel 
- Thyroid Panel 
- Coagulation Panel 
• Collect Blood Sample for Serum Prolactin. 
• Collect Blood Sample for b-hCG Serum Pregnancy Test (female subjects).  
• Collect Urine Sample for: 
- Urine Drug Screen 
- Urine Alcohol Test 
• Administer C-SSRS (Since Last Visit version; pre-oral dose assessment). 
• Record Concomitant Medications. 
• Record Pretreatment Events. 
• Subjects will fast for 8 hours before receiving study drug on Day -7. 
10.5.3. 
Treatment/Observation Period, Days -7 to 28 
Subjects are required to be inpatient until at least Day 15. 
Dosing with oral lurasidone tablets to ensure subjects are able to tolerate treatment with 
lurasidone will occur on Day -7 and Day -6 (single oral lurasidone 80 mg dose each day). 
Safety monitoring and washout of oral lurasidone will occur until Day -1. 
Subjects who tolerate oral lurasidone will be randomized on Day 1 to either lurasidone or 
placebo injection. Safety monitoring and observation (including assessment of the injection site) 
as well as PK and pharmacodynamic assessments during the inpatient period will occur from 
Day 1 through Day 15. 
Subjects may be discharged on Day 15 if in the Investigator’s opinion the subject is clinically 
stable. 
Subjects may remain inpatient at the Investigator’s discretion up to Day 33. 
10.5.3.1. Day -7 (Oral Lurasidone Dosing) 
The following study related procedures will be performed predose: 
• Awaken Subject. 
• Provide breakfast (350 calories). 
• Obtain Vital Signs. 
• Perform 12-Lead ECG. 
• Collect Blood Sample for PK. 
• Administer PANSS. 


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• Dispense Oral Lurasidone and Observe Subject Administer Dose. 
• Record Concomitant Medications. 
• Record Adverse Events. 
The following study related procedures will be performed 2 hours postdose: 
• Obtain Vital Signs. 
• Perform 12-Lead ECG. 
• Collect Blood Sample for PK. 
• Administer C-SSRS (Since Last Visit version). 
• Record Concomitant Medications. 
• Record Adverse Events. 
• Subjects will fast for 4 hours postdose. 
• Subjects will fast for 8 hours before receiving study drug on Day -6. 
10.5.3.2. Day -6 (Oral Lurasidone Dosing) 
The following study related procedures will be performed predose: 
• Awaken Subject. 
• Provide breakfast (350 calories). 
• Obtain Vital Signs (time-matched to predose on Day -7). 
• Perform 12-Lead ECG (time-matched to predose on Day -7). 
• Collect Blood Sample for PK. 
• Dispense Oral Lurasidone and Observe Subject Administer Dose. 
• Record Concomitant Medications. 
• Record Adverse Events. 
The following study related procedures will be performed 2 hours postdose: 
• Obtain Vital Signs. 
• Perform 12-Lead ECG. 
• Record Concomitant Medications. 
• Record Adverse Events. 
• Subjects will fast for 4 hours postdose. 
10.5.3.3. Days -5 to -1 (Safety and Tolerability Observation) 
The following study related procedures will be performed: 
• Awaken Subject (daily). 


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• Provide Meals (daily). 
• Obtain Vital Signs on Day -1 (time-matched to predose on Day -7). 
• Administer C-SSRS on Day -1 (Since Last Visit version; pre-injection dose 
assessment). 
• Record Concomitant Medications. 
• Record Adverse Events. 
10.5.3.4. Day 1 (Baseline/Randomization and Lurasidone or Placebo Injection Dosing) 
The following study related procedures will be performed predose: 
• Awaken Subject. 
• Provide Meals. 
• Obtain Vital Signs. 
• Perform 12-Lead ECG. 
• Collect Blood and Urine Samples for Clinical Laboratory Tests (time-matched to 
Predose on Day -7): 
- Hematology 
- Serum Chemistry 
- Urinalysis 
- Lipid Panel 
- Thyroid Panel 
- Coagulation Panel 
• Collect Blood Sample for Serum Prolactin. 
• Collect Blood Sample for PK (predose). 
• Collect Urine Sample for PK (-0.5 to 0 hours predose). 
• Administer PANSS. 
• Randomize Subject. 
• Dispense Lurasidone or Placebo Injection. 
• Administer Lurasidone or Placebo Injection. 
• Record Concomitant Medications. 
• Record Adverse Events. 
The following study related procedures will be performed postdose: 
• Subject Injection Site Pain Assessment immediately postdose, and 6 hours and 
12 hours postdose. A window of +1 minute is allowed for the immediately after 


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injection timepoint, and a window of ± 5 minutes is allowed for the 6 and 12 hour 
timepoints. 
• Investigator Injection Site Safety Assessment immediately postdose, and 6 hours and 
12 hours postdose. A window of +1 minute is allowed for the immediately after 
injection timepoint, and a window of ± 5 minutes is allowed for the 6 and 12 hour 
timepoints. In addition subjects will be monitored for potential allergic reaction for 
15 minutes after injection. A window of 0-5 minutes is allowed for this assessment. 
• Obtain Vital Signs at 6 and 12 hours postdose. 
• Perform 12-lead ECG at 6 and 12 hours postdose. 
• Collect Blood Sample for PK at 2, 4, 6, 12 hours postdose. 
• Collect Urine Sample for PK at 0 to 24 hours postdose. 
• Administer C-SSRS (Since Last Visit version) at 12 hours postdose. 
• Record Concomitant Medications. 
• Record Adverse Events. 
10.5.3.5. Days 2 to 8 (Safety and Tolerability Observation) 
The following study related procedures will be performed: 
• Awaken Subject (daily). 
• Provide Meals (daily). 
• Subject Injection Site Pain Assessment on Days 2 and 8. 
• Investigator Injection Site Safety Assessment (daily). 
• Obtain Vital Signs on Days 3, 5, and 7(time-matched to the injection predose 
timepoint on Day 1). 
• Perform 12-Lead ECG on Days 3, 5, and 7 (time-matched to the injection predose 
timepoint on Day 1). 
• Collect Blood and Urine Samples for Clinical Laboratory Tests on Day 8 
(time-matched to the injection predose timepoint on Day 1): 
- Hematology 
- Serum Chemistry 
- Urinalysis 
• Obtain Blood Sample for Serum Prolactin (Day 8). 
• Collect Blood Sample for PK at 24, 48, 72, 96, 120 and 144 hours post-injection dose. 
• Collect Urine Sample for PK at 24 to 48, 48 to 72, 72 to 96, 96 to 120, and 120 to 
144 hours post-injection dose. 
• Administer C-SSRS on Day 7. 


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• Administer PANSS on Day 8. 
• Record Concomitant Medications (daily). 
• Record Adverse Events (daily). 
10.5.3.6. Days 9 to 14 (Safety and Tolerability Observation) 
The following study related procedures will be performed: 
• Awaken Subject (daily). 
• Provide Meals (daily). 
• Investigator Injection Site Assessment (daily). 
• Obtain Vital Signs on Days 9, 11, and 13 (time-matched to the injection predose 
timepoint on Day 1) 
• Perform 12-Lead ECG on Days 9, 11, and 13 (time-matched to the injection predose 
timepoint on Day 1). 
• Record Concomitant Medications (daily). 
• Record Adverse Events (daily). 
10.5.3.7. Day 15 (Safety and Tolerability Observation) 
• Awaken Subject. 
• Provide Meals. 
• Subject Injection Site Pain Assessment. 
• Investigator Injection Site Safety Assessment. 
• Perform Physical Examination. 
• Obtain Vital Signs (time-matched to the injection predose timepoint on Day 1). 
• Perform 12-Lead ECG (time-matched to the injection predose timepoint on Day 1. 
• Collect Blood and Urine Samples for Clinical Laboratory Tests: 
- Hematology 
- Serum Chemistry 
- Urinalysis 
- Lipid Panel 
- Thyroid Panel 
- Coagulation Panel 
• Collect Blood Sample for Serum Prolactin. 
• Blood Sampling for Serum PK. 


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• Administer C-SSRS (Since Last Visit version). 
• Administer PANSS. 
• Record Concomitant Medications. 
• Record Adverse Events. 
• Schedule Next Visit. 
• Discharge Subject (if subject is clinically stable in the Investigator’s opinion). 
10.5.3.8. Day 22 (Safety and Tolerability Observation) 
Subjects may remain inpatient at the Investigator’s discretion throughout the Treatment and 
Observation Period. 
Subjects who have been discharged on Day 15 will have a clinic visit on Day 22. 
The following study related procedures will be performed: 
• Awaken Subject (daily if inpatient). 
• Provide Meals (daily if inpatient). 
• Obtain Vital Signs on Day 22 (approximately time-matched to the injection predose 
timepoint on Day 1). 
• Perform 12-Lead ECG on Day 22 (approximately time-matched to the injection 
predose timepoint on Day 1). 
• Collect Blood and Urine Samples for Clinical Laboratory Tests on Day 22 
(time-matched to the injection predose timepoint on Day 1): 
- Hematology 
- Serum Chemistry 
- Urinalysis 
• Obtain Blood Sample for Serum Prolactin on Day 22. 
• Obtain Blood Sample for PK On Day 22. 
• Administer C-SSRS on Day 22. 
• Administer PANSS on Day 22. 
• Schedule Next Visit. 
• Discharge Subject (if clinically stable in the Investigator’s opinion). 
• Subject Injection Site Pain Assessment on Day 22. 
• Investigator Injection Site Safety Assessment on Day 22. 
• Record Concomitant Medications. 
• Record Adverse Events. 


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10.5.4. 
Days 29 to 33 (End of Safety and Tolerability Observation and Beginning of 
Restabilization) 
Subjects are required to be inpatient Days 29 to 33. Day 29 is the end of the safety and 
tolerability observation period for lurasidone injectable suspension/placebo injection. Day 29 is 
also the start of the restabilization period. 
Restabilization’ refers to the reintroduction of each subject’s prior medications that were taken 
prior to entry into the study including their psychotropic medications. For early termination 
patients who received lurasidone dosing, following follow-up procedures they will need to be 
restabilized following the restabilization procedures. 
Subjects who discontinue the study prior to Day 29 will undergo assessments scheduled for 
Day 29 at the time of discontinuation. 
10.5.4.1. Day 29 (End of Safety and Tolerability Observation and Beginning of 
Restabilization) 
• Awaken subject (if inpatient). 
• Provide meals (if inpatient). 
• Admit subject to clinic (if previously discharged). 
• Perform Physical Examination. 
• Record Weight and BMI. 
• Obtain Vital Signs (approximately time matched to the injection predose timepoint on 
Day 1). 
• Perform 12-Lead ECG (approximately time matched to the injection predose 
timepoint on Day 1). 
• Collect Blood and Urine Samples for Clinical Laboratory Tests on (time matched to 
the injection predose timepoint on Day 1): 
- Hematology 
- Serum Chemistry 
- Urinalysis 
- Lipid Panel 
- Coagulation Panel 
- Thyroid Panel 
• Obtain Blood Sample for Serum Prolactin. 
• Obtain Blood Sample for PK. 
• Obtain Blood Sample for b-hCG Serum Pregnancy Test (female subjects). 
• Obtain Urine Sample for Urine Drug Screen and Urine Alcohol Test. 
• Administer C-SSRS (Since Last Visit version). 


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• Administer PANSS. 
• Subject Injection Site Pain Assessment. 
• Investigator Injection Site Safety Assessment. 
• Record Concomitant Medications. 
• Reintroduce prior psychotropic medications. 
• Record Adverse Events. 
10.5.4.2. Days 30-32 (Restabilization) 
The following procedures will be performed: 
• Awaken Subject. 
• Provide Meals. 
• Continue prior psychotropic medications. 
• Record Concomitant Medications. 
• Record Adverse Events. 
10.5.4.3. Day 33 (End of Restabilization) 
The following study-related procedures will be performed: 
• Awaken Subject. 
• Provide Meals. 
• Perform Physical Examination. 
• Record Weight and BMI. 
• Obtain Vital Signs (approximately time-matched to the injection predose timepoint on 
Day 1). 
• Perform 12-Lead ECG (approximately time-matched to the injection predose 
timepoint on Day 1). 
• Collect Blood and Urine Samples for Clinical Laboratory Tests (time-matched to the 
injection predose timepoint on Day 1): 
- Hematology 
- Serum Chemistry 
- Urinalysis 
• Collect Blood Sample for Serum Prolactin. 
• Administer C-SSRS (Since Last Visit version). 
• Continue prior psychotropic medications. 
• Record Concomitant Medications. 


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• Record Adverse Events. 
• Schedule Next Visit. 
• Discharge Subject. 
10.5.5. 
Follow-up/Study Completion, Day 61 ± 2 
All subjects will have an outpatient follow-up safety visit. 
Subjects who discontinue the study after Day 29 but prior to Day 61 will undergo assessments 
scheduled for Day 61 at the time of discontinuation. 
The following study-related procedures will be performed: 
• Perform Physical Examination. 
• Record Weight and BMI. 
• Obtain Vital Signs. 
• Perform 12-Lead ECG. 
• Collect Blood and Urine Samples for Clinical Laboratory Tests: 
- Hematology 
- Serum Chemistry 
- Urinalysis 
• Collect Blood Sample for Serum Prolactin. 
• Collect Blood Sample for PK. 
• Administer C-SSRS (Since Last Visit version). 
• Record Concomitant Medications. 
• Record Adverse Events. 


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11. 
SAFETY REPORTING 
11.1. 
Definitions 
11.1.1. 
Adverse Events 
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether 
or not considered drug related. 
Untoward medical occurrences that occur between the time of signing the informed consent form 
(ICF) and drug administration are pre-treatment events. Those that occur after administration of 
study drug are considered AEs. Pre-treatment hospitalizations that occur in accordance with local 
clinical practice during the screening period (for wash-out from prior or concomitant 
medications) will not be considered as SAEs and do not need to be reported as such. Any 
untoward event that may occur during the hospitalization must be recorded as a pretreatment 
event. If hospitalization is prolonged by an untoward event, the event must be reported as 
an SAE. 
An AE can, therefore, be any unfavorable and unintended sign (including an abnormal or 
clinically significant laboratory finding), symptom, or disease occurring after the administration 
of a medicinal (investigational) product, whether or not considered related to the medicinal 
(investigational) product. AEs may include the onset of new illness and the exacerbation of 
pre-existing conditions. 
The Investigator should attempt to establish a diagnosis of the event based on signs, symptoms, 
and/or other clinical information. In such cases, the diagnosis should be documented as the AE 
and not the individual signs/symptoms. 
11.1.2. 
Serious Adverse Events 
A serious adverse event (SAE) is pretreatment event or an AE that meets one or more of the 
following criteria: 
• Results in death. 
• Is life-threatening. 
• Requires hospitalization or prolongation of existing hospitalization. 
• Results in persistent or significant disability or incapacity. 
• Is a congenital anomaly or birth defect. 
• Is an important medical event that may jeopardize the subject or may require a 
medical or surgical intervention to prevent one of the outcomes listed above. 
Examples of such medical events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias or convulsions that do 
not result in inpatient hospitalization. 
The term “severe” is often used to describe the severity of a specific event (as in mild, moderate, 
or severe myocardial infarction) (see Section 11.3); the event itself, however, may be of 


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relatively minor medical significance (such as severe headache). This is not the same as 
“serious,” which is based on subject/event outcome or action criteria usually associated with 
events that pose a threat to a subject’s life or functioning as defined by the criteria above. 
During the study, if a subject has a hospitalization or procedure (eg, elective surgery) that was 
scheduled before the study entry, ie, before informed consent for an event/condition that 
occurred before the study, the hospitalization is considered a therapeutic intervention and not the 
result of a SAE. However, if the event/condition worsens during the study, it should be reported 
as an AE (or SAE, if the event/condition results in a serious outcome such as prolongation of 
hospitalization). 
Life-threatening means that the subject was, in the view of the Investigator, at immediate risk of 
death from the event as it occurred. This definition does not include an event that had it occurred 
in a more severe form might have caused death. 
SAE criteria information will be captured on the CRF. 
11.2. 
Objective Findings 
Clinically significant abnormal objective findings (eg, clinical laboratory value, ECG value, and 
physical examination observation) will also be recorded as AEs. 
When a clear diagnosis is available that explains the objective findings, this diagnosis will be 
recorded as the AE, and not the abnormal objective finding (eg, viral hepatitis will be recorded as 
the AE, not transaminase elevation). If a definite diagnosis is not available, then the sign 
(eg, clinically significant elevation of transaminase levels) or symptom (eg, abdominal pain) will 
be recorded as the AE. 
Clinical laboratory test results will be reviewed by the Investigator. The Investigator must 
determine the clinical significance of all out of range values. Clinical laboratory test with 
possibly drug-related or clinically relevant abnormal values of uncertain causality may be 
repeated. Any abnormal values that persist should be followed at the discretion of the 
Investigator. 
Clinical Laboratory Tests Outside the Normal Range: Any value outside the normal range will be 
flagged for the attention of the Investigator or appropriate designee at the study center. The 
Investigator or appropriate designee will indicate whether or not the value is of clinical 
significance. If the result of any test (or repeat test, if done) from the samples taken during 
Screening is indicated as clinically significant and is not covered by the inclusion criteria in 
Section 7.1, the subject will not be allowed into the study. Additional testing during the study 
may be done if medically indicated. If a clinically significant abnormality is found in the samples 
taken after dosing, during the study, and/or at the Follow-Up/Study Completion Visit, this should 
be recorded as an AE and the subject will be followed until the test(s) has (have) normalized or 
stabilized. 
All on-site ECG tracings and ECG over-read reports will be reviewed by the Investigator. The 
Investigator must determine the clinical significance of all abnormal ECGs. ECG with possibly 
drug-related or clinically relevant abnormal findings of uncertain causality may be repeated. Any 
abnormal ECGs that persist should be followed at the discretion of the Investigator. ECG 
tracings will be initialed and dated on all pages by the Investigator. 


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11.3. 
Collection and Recording of Adverse Events 
All pre-treatment events and AEs must be recorded in the subject’s study records/source 
documents in accordance with the Investigator’s normal clinical practice. 
All pre-treatment events and AEs must be recorded on the CRF. 
Pre-treatment events will be recorded from the time informed consent is provided at Screening 
until just prior to first lurasidone oral tablet study drug dose at Day -7. AEs will be recorded 
beginning after first study drug dose administration on Day 1 until the follow-up/study 
completion visit at Day 61 (± 2). 
All AEs will be followed until resolution, stabilization of the condition, the event is otherwise 
explained, or the subject is lost to follow-up. 
Each AE is to be evaluated for duration, severity, frequency, seriousness, action taken with the 
study treatment, outcome, and causal relationship to the study treatment. Definitions for severity, 
frequency, action taken with the study treatment, outcome, and causal relationship to the study 
treatment are presented below. 
The severity of AE: 
• Mild – Ordinarily transient symptoms that do not influence performance of subject’s 
daily activities. Other treatment is not ordinarily indicated. 
• Moderate – Marked symptoms sufficient to make the subject uncomfortable. 
Moderate influence on performance of subject’s daily activities. Other treatment may 
be necessary. 
• Severe – Symptoms cause considerable discomfort. Substantial influence on subject’s 
daily activities. May be unable to continue the study, and other treatment may be 
necessary. 
The frequency of AE: 
• Once – an isolated episode. 
• Intermittent – occurs on two or more separate occasions. 
• Continuous – does not abate from date of onset to date of resolution. 
The outcome of the AE: 
• Recovered/Resolved 
• Recovering/Resolving 
• Not Recovered/Not Resolved 
• Recovered/Resolved with Sequelae 
• Fatal 
• Unknown 
The causal relationship of the AE to the study treatment: 
• Not related 


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o Not related – Improbable temporal relationship and is plausibly related to 
other drugs or underlying disease. 
• Related 
o Possible – occurred in a reasonable time after study drug administration, but 
could be related to concurrent drugs or underlying disease. 
o Probable – occurred in a reasonable time after study drug administration, is 
unlikely to be attributable to concurrent drugs or underlying disease, and there 
is a plausible mechanism to implicate the study drug. 
o Definite – occurred in a reasonable time after study drug administration and 
cannot be explained by concurrent drugs or underlying disease. The AE 
should respond to dechallenge/rechallenge, however, this is not mandatory 
before assigning a definite causality. 
The Medical Advisor is the initial contact person for protocol related questions or discussion of 
AEs. The contact information for the Medical Advisor as well as other emergency contact 
information can be found in Table 1 of this protocol. 
11.4. 
Immediately Reportable Events 
The following medical events must be immediately reported to the Sponsor: 
• SAE 
• Pregnancy 
Emergency contact information can be found in Table 1. 
11.4.1. 
Serious Adverse Event 
If the Investigator or study center staff becomes aware of an SAE that occurs in a study subject 
up to and including the final follow-up, this must be reported immediately to the Sponsor 
whether considered related or unrelated to the study drug. SAEs must be recorded on the CRF 
and the data recorded should agree with that on the SAE form. 
Following the end of subject participation in the study, the Investigator or an authorized delegate 
should report SAEs “spontaneously” to the Sponsor PPD Pharmacovigilance (PVG) if 
considered at least possibly related to the study drug. 
SAEs will be followed until resolution, loss to follow-up, stabilization of condition, or the event 
is otherwise explained. 
In addition to the initial telephone notification, an initial SAE form as applicable must be 
completed and signed and sent via fax or email (see Table 1) to the Sponsor PPD-PVG within 
24 hours of the Investigator or study center staff becoming aware of the event. The SAE form 
must be signed by the Investigator or appropriate designee. The Sponsor PPD-PVG provides the 
SAE form used to report SAEs. 
SAEs must be promptly reported to the Institutional Review Board (IRB) or Independent Ethics 
Committee (IEC) by the Principal Investigator or the appropriate person at the study center if 
required per IRB/IEC guidelines. 


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The appropriate PVG group must be contacted immediately upon first knowledge of the incident. 
The immediate report should be made by the Investigator within a very short period of time and 
under no circumstances should this exceed 24 hours following knowledge of the SAE or 
pregnancy. 
11.4.2. 
Pregnancy 
Pregnancies that occur from the time that informed consent is signed through the final 
follow-up/study completion visit will be collected and reported on the Pregnancy Event Form. 
If a subject becomes pregnant during the course of the study, she will be instructed to return 
promptly/within 48 hours of the first notification of pregnancy to the study center and undergo a 
serum/urine pregnancy test, as confirmation of pregnancy. Every effort will be made to follow up 
all pregnancies, including those in the female partner of male subjects, until resolution 
(ie, termination [voluntary or spontaneous] or birth), providing the volunteers consent to 
follow-up. 
To report a pregnancy, the Pregnancy Event Form must be completed and sent via fax to 
PPD-PVG within 24 hours of the Investigator or study center staff becoming aware of the 
pregnancy The Sponsor provides the Pregnancy Event Form. 
Pregnancy itself is not regarded as an AE unless there is a suspicion that the study drug may have 
interfered with the effectiveness of a contraceptive medication or other AEs were detected. 
 


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12. 
TERMINATION OF SUBJECT FROM 
STUDY/DISCONTINUATION OF STUDY DRUG 
12.1. 
Criteria for Subject Termination 
Subjects may terminate the study participation at any time for any reason. 
The possible reasons for the termination of study participation are as follows: 
• Adverse event. 
• Lost to follow-up (specify). 
• Pregnancy. 
• Withdrawal by subject (specify). 
• Protocol deviation (specify). 
• Death. 
• Other (specify). 
If at any time during the course of the study, in the opinion of the Investigator, the subject may 
no longer safely participate due to a change in medical status (eg, experiences an AE, becomes 
pregnant), the subject must be discontinued from the study. 
The reason for discontinuation and information on the epoch will be recorded on the appropriate 
CRF. In case of death, the date of death should be captured on the CRF. 
Alternate subjects may be admitted to the clinical site in order to ensure that 8 subjects are dosed 
in each cohort. Subjects who are randomized but not dosed will be replaced by the alternate 
subject(s). 
Once 8 subjects per cohort are dosed, alternate subjects who are not needed to complete 
enrollment of a cohort will be discharged following reintroduction of their prior medication if 
they are clinically stable (in the Investigator’s opinion). 
Subjects who discontinue the study prior to Day 29 will undergo assessments scheduled for 
Day 29 at the time of discontinuation (see Section 10.5.4.1). Subjects who discontinue the study 
after Day 29 but prior to Day 61 will undergo assessments scheduled for Day 61 at the time of 
discontinuation (see Section 10.5.5). 


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13. 
STUDY TERMINATION 
The Sponsor reserves the right to discontinue the study at this study center for safety or 
administrative reasons at any time while safeguarding that early termination does not 
compromise subjects’ safety or well-being. In particular, a study center that does not recruit at an 
acceptable rate may be closed. Should the study be terminated and/or the study center closed for 
whatever reason, all documentation and study medications pertaining to the study must be 
returned to the Sponsor or its representative. 
If, in the opinion of the Investigator, clinical observations suggest it may be unsafe to continue, 
the Investigator may terminate part or the entire study after consultation with the Sponsor. 
In the event of study or site termination, subjects will be required to undergo final study 
assessments scheduled for the Day 61 (± 2) visit at the time of discontinuation. After study 
completion, subjects will be provided with access to standard care. 
14. 
STATISTICS 
The comprehensive statistical analysis plan (SAP) will provide details on the statistical methods 
planned for this study and will be finalized prior to database lock. 
14.1. 
Sample Size 
There will be no formal estimation for the sample size as no previous human PK data are 
available for lurasidone injectable suspension and the primary endpoints are safety. The sample 
size of 8 subjects per cohort (6 lurasidone injectable suspension subjects and 2 placebo subjects) 
is selected based on clinical and practical considerations for a study of this design. 
Approximately 70 subjects are planned overall to ensure that up to 40 subjects receive lurasidone 
injectable suspension or placebo. 
14.2. 
Analysis Populations 
Three analysis populations will be defined: 
• Safety population: The Safety population will consist of all subjects who were 
randomized and received study drug. All analyses will be performed according to 
treatment received. This population will be used for analysis of baseline and 
safety data. 
• Pharmacokinetic (PK) population: The PK population includes Safety population 
subjects who received lurasidone injectable suspension (active) and have at least 
1 postdose quantifiable serum or urine lurasidone injectable suspension and 
metabolite(s) concentration. This population will be used for PK analysis. 
• Pharmacodynamic (PD) population: The PD population will include all subjects in 
the Safety Population who have valid baseline and at least one post-baseline PANSS 
assessment. 


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14.3. 
Data Analysis 
Descriptive summary statistics for continuous variables will include the number of subjects (n), 
mean, standard deviation (SD), median, minimum and maximum. Descriptive summary statistics 
for categorical variables will include frequency counts and percentages (n [%]). Subjects 
dosed with placebo will be analyzed as a pooled group. Descriptive summary statistics for 
PK parameters will also include coefficient of variation (CV%), geometric mean and 
geometric CV%. 
SAS® Version 9.4 or higher will be used for all analyses. 
14.3.1. 
Subject Disposition 
The total number of screened subjects, the number of subjects who are screen failures, and the 
number of subjects randomized will be presented. The number and percentage of subjects who 
were randomly assigned to treatment and dosed and not dosed, who were included in each 
population will be summarized. The number and percentage of subjects who complete and 
discontinue study will be summarized, along with reasons for study discontinuation. Subject 
disposition will be displayed by treatment and overall. 
14.3.2. 
Drug Exposure and Compliance 
A data listing, by subject, containing the study medication dosing and dosing errors, if any, will 
be provided. Because this is a single dose study, treatment compliance will not be summarized. 
14.3.3. 
Important Protocol Deviations 
Important protocol deviations (IPDs) will be identified and documented based on a review of 
potentially IPDs. The potentially IPDs will be identified through programmatic checks of study 
data, as well as through review of selected data listings. The potentially IPDs to be reviewed 
include, but are not limited to, subjects who: 
• Did not meet inclusion/exclusion criteria 
• Received any disallowed concomitant medication 
• Informed consent date obtained after date of study medication 
• Other 
Additional IPDs may be identified from clinical review of Investigator comments or other data. 
Individual IPDs will be presented in a data listing. 
14.3.4. 
Demographic and Baseline Characteristics 
The number and percentage of subjects in each racial group will be summarized. Age, height, 
weight, and BMI may be summarized using descriptive statistics (number of subjects, mean, 
standard deviation, median, minimum, and maximum). 
The medical history of subjects will be coded by System Organ Class (SOC) and Preferred Term 
(PT) using Medical Dictionary for Regulatory Activities (MedDRA v. 20.1 or higher). The 
number and percentage of subjects with abnormal findings in each SOC and each PT will be 
summarized. 


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14.3.5. 
Safety Analyses 
14.3.5.1. Adverse Events 
All AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA) 
version 20.1 or higher. AEs are untoward medical occurrences: 
• that occurred on or after the study medication, 
• with a missing start date and a stop date on or after the study medication, or 
• with both a missing start and stop date. 
AEs will be summarized by treatment and by MedDRA system organ class (SOC) and Preferred 
Term (PT). 
The following AEs will be summarized and presented by treatment and by MedDRA SOC and 
PT for the Safety population: 
• All AEs (including number of events and subject incidence). 
• AEs by severity (mild, moderate, severe). 
• AEs by relationship to the study treatment (related, or not related). 
The following conventions will be followed in summarizing AEs: 
• For subject incidence summaries, each subject will be counted only once within each 
SOC and within each preferred term. 
• If a subject reports more than one AE within a preferred term and/or a system organ 
class, the AE with the highest known severity within each system organ class and 
within each preferred term will be included in the summaries by severity. 
• For summaries by relationship to the study medication, AEs will be grouped as 
“related” or “not related,” AEs with relationship to study medication assessed as 
“possible,” “probable,” or “definite” will be grouped as “related,” and AEs with 
relationship to study medication assessed as “not related” will be summarized as “not 
related.” If a subject reports more than one AE within the same treatment regimen, 
SOC and PT, and any are related, it will be summarized as related. 
Summaries of SAEs and AEs leading to study discontinuation will be provided. Additional 
summaries may be provided using AEs of special interest. 
A listing of all AEs, as well as a listing of deaths, a listing of SAEs, and a listing of AEs leading 
to study discontinuation will be provided. 
14.3.5.2. Clinical Laboratory Assessments 
All summaries involving clinical chemistry, hematology, and urinalysis tests will be based on the 
Safety population. 
Descriptive statistics for observed value and change from baseline will be displayed at each visit 
by treatment for each chemistry, hematology, and urinalysis laboratory test measured on a 
continuous scale. 


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Serum prolactin values will be summarized by treatment and gender. 
The normal reference ranges for laboratory tests will be used to determine whether the laboratory 
test value is below, within, or above the normal range. Shifts from baseline will be produced by 
treatment to show the percentage of subjects with laboratory test values below, within, and above 
the normal range. 
The number and percentage of subjects with a Markedly Abnormal Post-baseline Laboratory 
value (MAPLV, to be defined in the SAP) for select parameters will be summarized by 
treatment. 
The data listings for laboratory parameters will flag values outside of the reference range. 
14.3.5.3. ECGs/Centrally-read ECG/Holter Monitor 
Observed values, as well as change from baseline in ECG parameters will be summarized by 
treatment. 
The number (percentage) of subjects with observed QTcF values > 450, > 480, and > 500 msec 
and increases in QTcF from baseline of > 30 and > 60 msec; increase in PR interval from 
baseline > 25% and a PR interval > 200 msec; increase in QRS interval from baseline > 25% and 
a QRS interval > 120 msec; decrease in HR from baseline > 25% and a HR < 50 bpm; and 
increase in HR from baseline > 25% and a HR > 100 bpm will be summarized by each treatment 
group, respectively. 
Electrocardiogram clinical interpretation of ECG findings will be presented in data listings. 
14.3.5.4. Vital Signs 
Body temperature, respiration rate, pulse rate (supine and standing), blood pressure (supine and 
standing), and weight will be summarized using descriptive statistics at each time point by 
treatment group. Changes from baseline will be summarized in the same manner. The number 
and percentage of subjects with Sponsor defined markedly abnormal post-baseline vital sign 
values (MAPVS) will be presented by treatment. 
The number and percentage of subjects with orthostatic hypotension and orthostatic tachycardia 
will be summarized by treatment. Orthostatic hypotension is defined as a decrease of 
≥ 20 mmHg in systolic blood pressure or ≥ 10 mmHg in diastolic blood pressure after the subject 
had been standing for at least 2 to 4 minutes, compared to the systolic and diastolic blood 
pressures measured in the supine position, respectively. Orthostatic tachycardia is defined as a 
pulse rate increase of at least 20 bpm and a pulse rate > 100 bpm after the subject was standing 
for at least 2 to 4 minutes, compared to the pulse rate measured in the supine position. 
14.3.5.5. Columbia-Suicide Severity Rating Scale (C-SSRS) 
The number and percentage of subjects with each type of suicidal ideation and suicidal behavior 
will be summarized by treatment. The number and percentage of subjects with treatment 
emergent suicidal ideation, serious suicidal ideation, and suicidal behavior will be summarized 
by treatment. 


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14.3.5.6. Physical Examination 
Findings from the physical examinations will be presented as follows: pre-existing clinically 
significant conditions recorded as medical history will be summarized, and new clinically 
significant conditions recorded as an AE will also be summarized. 
14.3.5.7. Investigator Injection Site Safety Assessment and Subject Injection Site Pain 
Assessment 
The investigator injection site safety assessment and subject injection site pain assessment will 
be summarized by treatment. Details will be provided in the SAP. 
14.3.5.8. Concomitant Medications 
All medications will be coded to indication-specific ATC (Anatomical Therapeutic Chemical) 
classification (ie, ATC level 3) and preferred term according to the World Health Organization 
Drug (WHODRUG) anatomical therapeutic chemical (ATC) classification level 3 and Preferred 
Term (PT) (2017 September 01 or more recent). 
Any medications taken during the course of the study, with a start date on or after the date of the 
dose of study medication; or with a start date prior to, and an end date on or after, the date of the 
dose of study medication, or marked as ongoing, will be considered concomitant medications. 
Medications that ended prior to the date of the dose of study medication will be considered prior 
medications. The number and percentage of subjects using each prior and concomitant 
medication will be summarized by treatment group and by ATC level 3 and PT using the Safety 
population. Subjects with multiple uses of a medication will be counted only once for a given 
ATC or PT. 
A detailed listing of prior and concomitant medications taken by subjects will be provided. 
14.3.5.9. Safety Subgroup Analyses 
Select safety data may be presented by age, gender, and/or race subgroups. Details will be 
provided in the SAP. 
14.3.6. 
Pharmacokinetic Analysis 
Serum and urine concentrations and PK parameters for lurasidone injectable suspension and its 
metabolites in serum and urine will be listed and summarized descriptively by dose level, and 
subdivided by gender in tabular or graphical formats, as appropriate. Descriptive summaries will 
include number of subjects, mean, standard deviation, coefficient of variation (CV%), minimum, 
median, maximum, geometric mean, and geometric CV%. Cmax, tmax, AUC0-last, and AUC0-inf for 
lurasidone injectable suspension will be the primary PK parameters and all others will be 
secondary PK parameters. 
Dose proportionality of lurasidone injectable suspension will be assessed using a power model 
for Cmax, AUC0-last, and AUC0-inf of lurasidone injectable suspension with a formula of ln 
(PK parameter) = α + β ln (dose level). 
The estimate of the slope (β), together with its 90% CI will be calculated from the model. Dose 
proportionality assessment will be performed for the dose range studied. 


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14.3.7. 
Pharmacodynamic Analyses 
The pharmacodynamic variable is change from baseline in PANSS total score. The 
pharmacodynamic variable will be analyzed by mixed model for repeated measures (MMRM) 
method. The MMRM model will include treatment, time, baseline score, and treatment-by-time 
interaction. Details will be provided in the SAP. 
14.3.8. 
Interim Analysis 
There is no planned interim analysis for this study. 
14.3.9. 
Treatment of Missing Data 
For analyses of change from baseline, baseline will generally be defined as the predose 
assessment on Day 1 as scheduled. If this value is unavailable, the last non-missing value prior to 
dosing will be used. Otherwise, missing observations will be treated as missing at random, and 
no data imputation will be performed. 
Details of incomplete/missing dates for any endpoint will be provided in the SAP. 
15. 
PROCEDURE FOR CLINICAL STUDY QUALITY CONTROL/ 
DATA COLLECTION, MANAGEMENT, AND QUALITY 
ASSURANCE 
15.1. 
Data Collection/Electronic Data Capture (EDC) 
The results from Screening and data collected during the study (except clinical laboratory test 
results) will be recorded in the subject’s electronic CRF. The study centers will use an EDC 
system that is compliant with relevant FDA regulatory requirements per 21 CFR Part 11 
(Medidata Rave). Password protected access to the EDC system will be via a secure website. 
Data queries and data corrections will be handled through the same system. All transactions 
within the EDC system are fully documented within an electronic audit trail. Each set of 
completed CRFs must be reviewed and electronically signed and dated by the Investigator. 
15.2. 
Computerized Systems Used for Source Data 
A list of the computerized systems that will be used to create, modify, maintain, archive, retrieve, 
or transmit source data are presented below, pursuant to the Guidance for Industry Computerized 
Systems Used in Clinical Investigations, May 2007. 


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Table 6: 
Computerized Systems Used for Source Data 
Protocol Step  
Computerized System Type or 
Description 
Informed Consent 
A 
Inclusion/Exclusion Criteria 
A 
Medical and Psychiatric History 
A 
Demographics 
A 
Physical Examination 
A 
Height 
A 
Weight and BMI 
A 
Vital Sign Measurements 
A 
12-Lead ECG 
A 
Clinical Laboratory Tests 
B 
Serum Prolactin 
B 
Serology 
B 
Serum Pregnancy Test (females) 
B 
Urine Drug Screen 
B 
Urine Cotinine 
B 
Urine Alcohol Test 
B 
Blood Sampling for Serum PK 
B 
Urine Samples for PK assessment 
B 
Psychotropic Medications 
A 
Columbia-Suicidality Severity Rating Scale (C-SSRS) 
A 
Positive and Negative Syndrome Scale (PANSS) 
A 
Clinical Site Admission 
A 
Awaken Subject 
A 
Provide Meals 
A 
Randomization 
A 
Oral Lurasidone Administration 
A 
Lurasidone or Placebo Injection Administration 
A 
Schedule Next Visit 
A 
Clinical Site Discharge 
A 
Concomitant Medications 
A 
Pretreatment Events 
A 
Adverse Events 
A 
Injection Site Reaction Assessment (Investigator) 
A 
Injection Site Pain (Subject) 
A 
Statistical analysis 
SAS®, version 9.4 or higher 
A = EDC; B = LIMS; C = eCOA. 
Abbreviations: EDC = electronic data capture; eCOA = electronic clinical outcome assessments; LIMS = laboratory 
information management system. 


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15.3. 
Study Monitoring 
This study will be monitored from initiation to completion by the Sponsor or its representative. 
Monitoring will include personal visits and telephone communication to assure that the 
investigation is conducted according to protocol and in order to comply with ICH GCP. On-site 
review of CRFs will include a review of forms for completeness and clarity, and consistency 
with source documents available for each subject. 
15.4. 
Audits 
The study may be subject to audit by the Sponsor/designee. If such an audit occurs, the 
Investigator must agree to allow access to required subject records. This is dependent on the 
subject granting consent by signing the ICF. By signing this protocol, the Investigator grants 
permission to personnel from the Sponsor or its representatives for on-site monitoring and 
auditing of all appropriate study documentation, as well as on-site review of the procedures 
employed in CRF generation, where clinically appropriate. 
In accordance with ICH GCP the Sponsor may select this study for audit. During the audit the 
Sponsor representative will carry out an inspection of center facilities (eg, pharmacy, drug 
storage areas, laboratory) and review study related records in order to evaluate the study 
compliance with the Sponsor/center SOPs, protocol, ICH GCP and local regulations. The 
Investigator or appropriate designee must also agree to inspection of all study documents by the 
regulatory authorities and the IEC. Should the Investigator or appropriate designee be notified of 
a regulatory inspection involving this study they should notify the Sponsor immediately. 
15.5. 
Study Documentation 
Study records are comprised of source documents, CRFs, and all other administrative 
documents, eg, IRB/IEC correspondence, clinical study materials and supplies shipment 
manifests, monitoring logs, Sponsor and CRO correspondence, etc. A study specific binder will 
be created and will follow standard practices the maintenance of study records. 
Source document is defined as any hand written or computer generated document that contains 
medical information or test results that have been collected for or are in support of the protocol 
specifications, eg, clinical laboratory reports, clinic notes, drug disbursement log, subject sign in 
sheets, subject completed questionnaires if applicable, telephone logs, ECGs, etc. All draft, 
preliminary and pre-final iterations of a final report are also considered to be source documents, 
eg, faxed laboratory reports and hard copy laboratory reports, faxed initial results and hard copy, 
final report. 
15.6. 
Clinical Laboratory Certification and Normal Values 
A local laboratory will be used for analysis for most of the clinical laboratory tests for this study. 
The local laboratory will provide the Investigator, Sponsor/CRO with laboratory certification(s), 
lab director’s curricula vitae and a dated copy of normal range values. 


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16. 
ETHICAL AND REGULATORY OBLIGATIONS 
16.1. 
Study Conduct 
The Investigator agrees that the study will be conducted according to the protocol, ICH Good 
Clinical Practice (GCP), ICH guidelines and the ethical principles that have their origin in the 
Declaration of Helsinki. The Investigator will conduct all aspects of the study in accordance with 
applicable local law(s) and regulation(s). 
The Investigator will assure proper implementation and conduct of the study including those 
study-related duties delegated to other appropriately qualified individuals. The Investigator will 
assure that study staff cooperate with monitoring and audits. 
The Investigator must sign and return to Sponsor/CRO the “Investigator Approval” page. 
The Investigator must provide a copy of current curriculum vitae (including a copy of a current 
medical license, current Drug Enforcement Agency (DEA) license, where applicable), and 
financial disclosure information. In countries where medical licensure is not issued, the 
following documentation is acceptable, as applicable: 
• Registration number/stamp with a registration number stated on curriculum vitae. 
• Appropriate diploma number stated on curriculum vitae. 
• Copy of the diploma. 
The Investigator must sign and return a completed Form FDA 1572 “Statement of Investigator” 
to Sponsor/CRO. 
16.2. 
Institutional Review Board/Independent Ethics Committee 
Documented approval for conducting the study from appropriate Institutional Review Board 
(IRB)/Independent Ethics Committee (IEC) will be obtained for all participating study centers 
prior to initiation of the study, according to ICH GCP, applicable local law(s) and regulation(s). 
When necessary, an extension, amendment or renewal of the IRB/IEC approval must be obtained 
and also forwarded to the Sponsor. The IRB/IEC must supply the Sponsor a list of the IRB/IEC 
membership, and a statement to confirm that the IRB/IEC is organized and operates according to 
ICH GCP, applicable law(s) and regulation(s). 
A copy of written IRB/IEC approval or favorable opinion of the protocol, informed consent form 
and subject recruitment material (if applicable) must be provided to Sponsor/CRO prior to start 
of the study. The approval or favorable opinion letter must be signed by the IRB/IEC chairman 
or designee identify the IRB/IEC name and address, identify the clinical protocol by title and/or 
protocol number, and include the date that approval or favorable opinion was granted. The letter 
must also contain a statement that the IRB/IEC complies with the requirements in 21 CFR 
Part 56 for a study conducted under a US IND or ICH GCP, as applicable. 
The Investigator/CRO is responsible for obtaining from the IRB/IEC continued review of the 
clinical research or submitting periodic progress reports, in accordance with applicable 
regulations, at intervals not to exceed one year and (if applicable) as otherwise additionally 


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specified by the IRB/IEC. The Sponsor must be supplied with written documentation of 
continued review of the clinical research. 
The Investigator must promptly inform their IRB/IEC of all SAEs reported by subjects enrolled 
in the study or other safety information reported from Sponsor/CRO in accordance with 
applicable law(s) and regulation(s). 
16.3. 
Informed Consent 
The Investigator will prepare the informed consent form and provide the form to Sponsor/CRO 
for approval prior to submission to the IRB/IEC. 
The informed consent form will be approved by the Sponsor/CRO prior to submission to the 
IRB/IEC. The Sponsor/CRO may provide a template informed consent form to be qualified by 
each research facility to conform to local requirements. All informed consent forms must contain 
the minimum elements as mandated by ICH GCP, applicable local law(s) and regulations and 
will be subject to Sponsor/CRO approval as well as IRB/IEC approval. The Sponsor/CRO may 
submit informed consent forms to a central IRB/IEC for review and approval or favorable 
opinion contingent upon prior Investigator permission and review. 
Before recruitment and enrollment, each prospective subject will be given a full explanation of 
the study, allowed to read the approved informed consent form and be provided ample time and 
the opportunity to ask any questions that may arise. Once all questions have been answered and 
the Investigator is assured that the prospective subject understands the implications of 
participating in the study, the prospective subject will be asked to give consent to participate in 
the study by signing the informed consent form. As part of the consent process, each prospective 
subject must consent to direct access to his/her medical records for study-related monitoring, 
auditing, IRB/IEC review, and regulatory inspection. It should be clearly explained to each 
prospective subject that participation in each and every clinical visit and assessment is expected. 
The subject may be discontinued from study medication, but that does not necessarily negate the 
expectation that the subject will continue to participate in the study through the final 
visit/assessment. The Investigator will provide a copy of the signed informed consent form to 
each subject, and will record the date of the informed consent on the CRF. 
If an amendment to the protocol changes the subject participation schedule in scope or activity, 
or if important new information becomes available that may be relevant to the subject’s consent, 
the informed consent form must be revised, submitted to the IRB/IEC for review and approval or 
favorable opinion. The revised informed consent form must be used to obtain consent from a 
subject currently enrolled in the study if he or she is affected by the amendment. The revised 
informed consent form must be used to obtain consent from any new subjects who are enrolled 
into the study after the date of the approval or favorable opinion of the protocol amendment. 
16.4. 
Subject Privacy 
The Sponsor (or Sponsor representative) or any designees affirm uphold the subjects 
confidentiality. The subject will be identified by unique code only; full names will be masked 
prior to transmission to the Sponsor. The confidentiality of the subject’s personal data shall be 
protected in accordance with appropriate laws and regulations. 


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If any cases are identified where the subject’s confidentiality has been breached, this must be 
rectified immediately. All subject identifiable information should be removed and the Sponsor 
notified. 
16.5. 
Protocol Amendments and Emergency Deviations 
All revisions and/or amendments to this protocol must be approved in writing by the Sponsor 
and the appropriate IRB/IEC. The Investigator will not make any changes to the conduct of the 
study or the protocol without first obtaining written approval from the Sponsor and the IRB/IEC, 
except where necessary to eliminate an apparent immediate hazard to a study subject. 
Emergency deviations or modifications may be initiated without Sponsor or IRB/IEC approval or 
favorable opinion, only in cases where the deviation or modification is necessary to eliminate or 
avoid an immediate apparent hazard to subjects. Emergency deviations or modifications must be 
reported to the Sponsor/CRO and the IRB/IEC immediately/within five business days of the 
occurrence, or in accordance with applicable regulatory requirements. 
16.6. 
Records Retention 
The Investigator/the study center must arrange for retention of study records at the study center 
for at least 15 years (or at least 25 years in the EU) from time of participation in the study or 
longer in accordance with applicable regulations and Sponsor SOPs. The Investigator/site should 
take measures to prevent accidental or premature destruction of these documents. Documents 
cannot be destroyed without written Sponsor authorization. The Sponsor will inform the 
Investigator/the study center when the destruction of documents is permitted. 
16.7. 
Inspection of Records 
In the event of an inspection, the Investigator agrees to allow representatives of the Sponsor and 
its representative and, the regulatory authorities’ access to all study records. The Investigator will 
promptly notify the Sponsor/CRO of all requests to inspect a Sunovion/DSP-sponsored study by 
government agencies and will promptly forward a copy of all such inspection reports. 
16.8. 
Financial Disclosure 
By signing this protocol, the Investigator agrees to provide to the Sponsor prior to start of study 
accurate financial information to allow the Sponsor to submit complete and accurate certification 
and disclosure statements as required by the US FDA regulations (21 CFR Part 54). The 
Investigator further agrees to provide this information on a Financial Disclosure/Certification 
Form that is provided by the Sponsor. The Investigator will update this information if there are 
any relevant changes during the conduct of the study and for one year after completion of 
the study. 
The Investigator also consents to the transmission of this information to the Sponsor for these 
purposes. This may involve the transmission of information to countries that do not have laws 
protecting personal data. 


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16.9. 
Publication Policy 
Any formal presentation or publication of data collected as a direct or indirect result of the study 
will be considered a joint publication by the Investigators and the appropriate personnel of the 
Sponsor. For multicenter studies, it is mandatory that the first publication is based on all data 
obtained from all analyses as stipulated in the protocol. Investigators participating in multicenter 
studies must agree not to present data gathered individually or by a subgroup of centers before 
the full, initial publication, unless this has been agreed to by all other Investigators and by the 
Sponsor. 
The Sponsor will disclose the study results, in the form of a clinical study report synopsis, to the 
IEC and the applicable regulatory authorities within one year of the end of the study. The format 
of this synopsis and that of the clinical study report should comply with ICH E3 guidelines for 
structure and content of a clinical study report. 
Investigators participating in multicenter studies must agree not to present data gathered 
individually or by a subgroup of centers before the full, initial publication, unless this has been 
agreed to by all other Investigators and by the Sponsor. 
16.10. 
Compensation 
If subjects have any adverse event or injury directly resulting from the study medications or 
procedures, the Sponsor will appropriately compensate in accordance with applicable regulatory 
requirements. 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
80 
 
13 June 2018 
17. 
REFERENCES 
Chesney E, Goodwin GM, Fazel S. Risks of all-cause and suicide mortality in mental disorders: 
a meta-review. World Psychiatry. 2014 Jun;13:153-60. 
Cloutier M, Aigbogun MS, Guerin A, et al. The Economic Burden of Schizophrenia in the 
United States in 2013. J Clin Psychiatry. 2016 Jun;77(6):764-71. 
FDA Guidance for Industry “Toxicity Grading Scale for Healthy Adult and Adolescent 
Volunteers Enrolled in Preventive Vaccine Clinical Trials,” 2007. 
Howes OD, Murray RM. Schizophrenia: an integrated sociodevelopmental-cognitive model. 
Lancet. 2014 May 10;383(9929):1677-87. 
Marwaha S, Johnson S. Schizophrenia and employment - a review. Soc Psychiatry Psychiatr 
Epidemiol. 2004 May;39(5):337-49. 
McGrath J, Saha S, Chant D, Welham J. Schizophrenia: a concise overview of incidence, 
prevalence, and mortality. Epidemiol Rev. 2008;30:67-76. 
Miyamoto S, Miyake N, Jarskog LF, Fleischhacker WW, Lieberman JA. Pharmacological 
treatment of schizophrenia: a critical review of the pharmacology and clinical effects of current 
and future therapeutic agents. Mol Psychiatry. 2012 Dec;17(12):1206-27. 
Owen MJ, Sawa A, Mortensen PB. Schizophrenia. Lancet. 2016 Jul 2;388(10039):86-97. 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
81 
 
13 June 2018 
18. 
INVESTIGATOR APPROVAL 
I have read the protocol, D1052024, Version 2.00, “A Randomized, Double Blind, Placebo 
Controlled, Single Ascending Dose Study with Lurasidone Injectable Suspension to Evaluate 
Safety, Tolerability, and Pharmacokinetics in Subjects with Schizophrenia”, and agree that it 
contains all necessary details for conducting the study and to conduct the study in strict 
accordance with the specifications outlined herein. 
I agree that no additional procedure(s) will be added during the conduct of the study except 
through protocol amendment by Sunovion Pharmaceuticals Inc. and/or Sumitomo Dainippon 
Pharma Co., Ltd. and after documentation of IRB approval. 
Investigator Signature: ____________________________________________________ 
Print Investigator Name: __________________________________________________ 
Date: ___________________________________________ 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
82 
 
13 June 2018 
19. 
APPENDIX I. CARDIAC SAFETY MONITORING (ECG) 
1. Requirements for Testing 
ECG equipment and supplies will be provided by [IQVIA] and should be used for all 
in-clinic protocol ECG assessments. 
• All 12-lead ECGs will be recorded in the same manner. 
• The study center personnel must be adequately trained in performing ECGs on the 
specific ECG equipment used in this protocol that is provided by the cardiac safety 
vendor. 
• To the extent possible, the same ECG machine and personnel should be used to 
acquire a subject’s ECGs throughout the period of their participation in the study. 
• ECGs will be recorded with at least one 10-second single-lead tracing recorded from 
Lead II. 
2. Subject Restrictions and Instructions 
• Prior to ECG acquisition, the subject will have rested 10 minutes in the supine 
position and will remain so until the ECG is obtained. 
3. Reporting 
• It is the responsibility of the Investigator to perform a safety review of the ECG data 
for changes from previous assessments and/or emergent cardiac dysfunction, and to 
determine subjects’ eligibility or continuance in the study. 
• ECGs will be reviewed, signed and dated by the Investigator listed on the Form 
FDA 1572 (MD or DO) after each ECG collection. The same Investigator should 
review all ECG reports for a given subject whenever possible. 
• For all ECGs, a report will be provided by the cardiac safety vendor to the study 
center for review and signature. 
• The ECG tracing will be kept with subject’s source documentation and/or CRF unless 
it is specified otherwise. The original ECG and the cardiologist’s over-read will be 
retained at the study center. 
4. Data Standardization 
ECG data will be transmitted to a centralized cardiac safety vendor and centrally over-read 
and interpreted using standardized procedures. 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
83 
 
13 June 2018 
20. 
APPENDIX II. CLINICAL LABORATORY TESTS 
HEMATOLOGY: (Differential reported as % and absolute value) 
Hemoglobin, Hematocrit, Platelet Count, RBC Count, WBC - Total Count, WBC Differential, 
(Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) 
BLOOD CHEMISTRIES: Alanine aminotransferase (ALT), Alkaline Phosphatase (ALP), 
Aspartate aminotransferase (AST), Bicarbonate (HCO3), Bilirubin (Total, Direct, Indirect), 
Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Creatinine, Glucose, Magnesium 
(Mg), Phosphorus (P), Potassium (K), Protein (Total), Sodium (Na), Uric Acid, Albumin 
URINALYSIS: Blood, Glucose, Ketones, Leukocyte esterase, Microscopic examination, 
Nitrites, pH, Protein 
LIPID PANEL: LDL-Cholesterol, HDL-Cholesterol, Triglycerides 
THYROID PANEL: Free T3, Free T4, Thyroid stimulating hormone (TSH) 
COAGULATION PANEL: PT, aPTT, INR 
URINE DRUG SCREENING: Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids, 
Cocaine, Cotinine, Methamphetamines, Methadone, Methylenedioxymethamphetamine 
(MDMA), Phencyclidine (PCP), Opiates, Oxycodone 
SEROLOGY PANEL: Hepatitis B Ag, Hepatitis C Ab, HIV-1 Ab, HIV-2 Ab 
OTHER TESTS: Urine Alcohol Test, Serum Pregnancy (β-hCG) (in female subjects only), 
Urine Pregnancy Test (female subjects only), Serum Prolactin 
Laboratory reports will be initialed and dated on all pages by the Investigator listed on the Form 
FDA 1572 (MD or DO). Laboratory test results will be reviewed by the Investigator as they 
become available. The Investigator must determine the clinical significance of all out-of-range 
lab values (except drug screens). Possibly drug-related or clinically relevant abnormal values of 
uncertain causality must be repeated. Any abnormal values that persist should be followed at the 
discretion of the Investigator. 
 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
84 
 
13 June 2018 
21. 
APPENDIX III. BLOOD AND URINE SAMPLE COLLECTION 
AND HANDLING GUIDELINES FOR PHARMACOKINETICS 
 
Please refer to the Laboratory Investigator Manual for all collection and shipping instructions. 
 
Blood must be collected from all subjects at the time points indicated below. 
Day No. 
Time Relative to Oral Lurasidone Dosing 
-7 
Predose and 2 hours postdose 
-6 
Predose and 2 hours postdose 
Day No. 
Timepoint Relative to Lurasidone or Placebo Injection Dosing 
1 
Predose and 2, 4, 6, and 12 hours postdose 
2 
24 hours post-injection dose 
3 
48 hours post-injection dose 
4 
72 hours post-injection dose 
5 
96 hours post-injection dose 
6 
120 hours post-injection dose 
7 
144 hours post-injection dose 
15 
336 hours post-injection dose 
22 
504 hours post-injection dose 
29 
672 hours post-injection dose 
61 
1440 hours post-injection dose 
 
COLLECTION REQUIREMENTS 
Collect 4 mL blood sample into a serum separator tube and allow to clot for 30 to 60 minutes at 
room temperature before centrifugation. The samples will be centrifuged within 1 hour of 
collection at approximately 2000 g for 10 minutes at approximately 4°C, preferably. To ensure a 
more homogenous sample, serum sample should first be transferred to 1 tube and mixed well, 
then split the sample with approximately equal volume into 2 appropriate cryovials/tubes, and 
label as PKS-Set 1 and PKS-Set 2. Store serum vials at approximately -20°C freezer within 
1 hour until shipping to the bioanalytical lab. The date and time of blood collection must be 
recorded. 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
85 
 
13 June 2018 
URINE SAMPLES 
Urine samples must be collected from all subjects at the time points indicated below. 
To prevent lurasidone nonspecific binding to collection devices, urine samples may be treated 
with an additive after each void. 
Detailed instructions on urine sample collection and treatment after each void will be provided in 
a Laboratory Manual. 
Day No. 
Time Interval Relative to Lurasidone or Placebo Injection Dosing 
1 
Predose -0.5 to 0 hour 
1/2 
0 to 24 hours post-injection dose 
2/3 
24 to 48 hours post-injection dose 
3/4 
48 to 72 hours post-injection dose 
4/5 
72 to 96 hours post-injection dose 
5/6 
96 to 120 hours post-injection dose 
6/7 
120 to 144 hours post-injection dose 
The date and time of sample collection must be recorded. 
Transfer each individual void/collection in the labeled timepoint storage collector. 
Store samples in a freezer at approximately -20ºC until shipping to the bioanalytical lab. 
Very important: Do not fill containers/tubes more than 75% of total volume to allow for volume 
expansion during freezing. Overfilled containers will burst! 
SHIPPING: 
• Set 1 and Set 2 samples will be shipped in 2 separate shipments to the appropriate 
laboratory. 
• Freeze samples for at least several hours before shipping to the appropriate 
laboratory. 
• All samples will be shipped with dry ice protection. 
 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
86 
 
13 June 2018 
22. 
APPENDIX IV. DRUGS KNOWN TO CONSISTENTLY 
PROLONG THE QT INTERVAL 
Generic Name 
Trade Name 
Amiodarone 
Cordarone, Pacerone 
Arsenic trioxide 
Trisenox 
Bepridil 
Vascor 
Chlorpromazine 
Thorazine 
Cisapride 
Propulsid 
Clarithromycin 
Biaxin 
Disopyramide 
Norpace 
Dofetilide 
Tikosyn 
Dolasetron Mesylate 
Anzamet 
Domperidone 
Motilium 
Droperidol 
Inapsine 
Erythromycin 
E.E.S., Erythrocin 
Gatifloxacin 
Tequin 
Halofantrine 
Halfan 
Haloperidol 
Haldol 
Ibutilide 
Corvert 
Levomethadyl 
Orlaam 
Mefloquine 
Larium 
Mesoridazine 
Serentil 
Methadone 
Dolophine, Methadose 
Moxifloxacin 
Avelox 
Pentamidine 
NebuPent 
Pentamidine 
Pentam 
Pimozide 
 
Orap 
Probucol 
Lorelco 
Procainamide 
Procan, Pronestyl 
Quinidine 
Cardioquin, Quiniglute 
Sotalol 
Betapace 
Sparfloxacin 
Zagam 
Tacrolimus 
Prograf 
Thioridazine 
Mellaril 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
87 
 
13 June 2018 
23. 
APPENDIX V. ADDITIONAL RESTRICTED SUBSTANCES 
CYP3A4 Inducer 
CYP3A4 Inhibitor 
Carbamazepine 
Amiodarone 
Phenobarbital 
Cimetidine 
Phenytoin 
Clarithromycin 
Pioglitazone 
Diltiazem 
Rifabutin 
Erythromycin 
Rifampin 
Fluvoxamine 
St John’s Wort 
Grapefruit and grapefruit 
juice 
 
Indinavir 
 
Itraconazole 
 
Ketoconazole 
 
Mibefradil 
 
Nefazodone 
 
Nelfinavir 
 
Ritonavir 
 
Verapamil 
 
Troleandomycin 
This is not an all-inclusive list of restricted enzyme inducers and inhibitors. 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
88 
 
13 June 2018 
24. 
APPENDIX VI: BODY MASS INDEX DETERMINATION 
Body mass index (BMI) will be calculated by measuring the subject’s height and weight (both 
determined without subject wearing shoes) and using these measurements (in centimeters and 
kilograms) in the following formulae. 
Formula: 
BMI = weight (kg) ÷ [height (cm) ÷ 100]2 
The entries in the following table list the BMI values for subjects of a given height and weight. 
Please note this table is not inclusive of all possible height and weight combinations. 


Protocol D1052024, Version 2.00 
Lurasidone Injectable Suspension 
Confidential and Proprietary 
89 
13 June 2018 
Body Mass Index (BMI) in kg/m2 According to Height and Weight 
BMI 
Height 
 
Cm 
142.2 
144.8 
147.3 
149.9 
152.4 
154.9 
157.5 
160.0 
162.2 
165.1 
167.6 
170.2 
172.7 
175.3 
177.8 
180.3 
182.9 
185.4 
188.0 
190.5 
193.0 
195.6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
kg 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
40.9 
 
20 
20 
19 
18 
18 
17 
17 
16 
15 
15 
15 
14 
14 
13 
13 
13 
12 
12 
12 
11 
11 
11 
43.2 
 
21 
21 
20 
19 
19 
18 
17 
17 
16 
16 
15 
15 
14 
14 
13 
13 
13 
13 
12 
12 
12 
11 
45.4 
 
21 
22 
21 
20 
20 
19 
18 
18 
17 
17 
16 
16 
15 
15 
14 
14 
14 
13 
13 
13 
12 
12 
47.6 
 
24 
23 
22 
21 
21 
20 
19 
19 
18 
18 
17 
16 
16 
16 
15 
15 
14 
14 
14 
13 
13 
12 
49.9 
 
25 
24 
23 
22 
22 
21 
20 
20 
19 
18 
18 
17 
17 
16 
16 
15 
15 
15 
14 
14 
13 
13 
52.3 
 
26 
25 
24 
23 
23 
22 
21 
20 
20 
19 
19 
18 
18 
17 
17 
16 
16 
15 
15 
14 
14 
14 
54.4 
 
27 
26 
25 
24 
23 
23 
22 
21 
21 
20 
19 
19 
18 
18 
17 
17 
16 
16 
15 
15 
15 
14 
56.8 
 
28 
27 
26 
25 
24 
24 
23 
22 
22 
21 
20 
20 
19 
18 
18 
17 
17 
17 
16 
16 
15 
15 
59.0 
 
29 
28 
27 
26 
25 
25 
24 
23 
22 
22 
21 
20 
20 
19 
19 
18 
18 
17 
17 
16 
16 
15 
61.4 
 
30 
29 
28 
27 
26 
26 
25 
24 
23 
23 
22 
21 
21 
20 
19 
19 
18 
18 
17 
17 
16 
16 
63.5 
 
31 
30 
29 
28 
27 
27 
26 
25 
24 
23 
23 
22 
21 
21 
20 
20 
19 
19 
18 
18 
17 
17 
65.9 
 
33 
31 
30 
29 
28 
27 
27 
26 
25 
24 
23 
23 
22 
21 
21 
20 
20 
19 
19 
18 
18 
17 
68.0 
 
34 
33 
31 
30 
29 
28 
27 
27 
26 
25 
24 
24 
23 
22 
22 
21 
20 
20 
19 
19 
18 
18 
70.5 
 
35 
34 
32 
31 
30 
29 
28 
28 
27 
26 
25 
24 
24 
23 
22 
22 
21 
20 
20 
19 
19 
18 
72.6 
 
36 
35 
34 
32 
31 
30 
29 
28 
28 
27 
26 
25 
24 
24 
23 
22 
22 
21 
21 
20 
20 
19 
75.0 
 
37 
36 
35 
33 
32 
31 
30 
29 
28 
28 
27 
26 
25 
24 
24 
23 
22 
22 
21 
21 
20 
20 
77.1 
 
38 
37 
36 
34 
33 
32 
31 
30 
29 
28 
27 
27 
26 
25 
24 
24 
23 
22 
22 
21 
21 
20 
79.5 
 
39 
38 
37 
35 
34 
33 
32 
31 
30 
29 
28 
27 
27 
26 
25 
24 
24 
23 
23 
22 
21 
21 
81.6 
 
40 
39 
38 
36 
35 
34 
33 
32 
31 
30 
29 
28 
27 
27 
26 
25 
24 
24 
23 
23 
22 
21 
84.1 
 
42 
40 
39 
37 
36 
35 
34 
33 
32 
31 
30 
29 
28 
27 
27 
26 
25 
24 
24 
23 
23 
22 
86.2 
 
43 
41 
40 
38 
37 
36 
35 
34 
33 
32 
31 
30 
29 
28 
27 
27 
26 
25 
24 
24 
23 
23 
88.6 
 
44 
42 
41 
39 
38 
37 
36 
35 
34 
33 
32 
31 
30 
29 
28 
27 
27 
26 
25 
24 
24 
23 
90.7 
 
45 
43 
42 
40 
39 
38 
37 
36 
34 
33 
32 
31 
30 
30 
29 
28 
27 
26 
26 
25 
24 
24 
93.2 
 
46 
44 
43 
41 
40 
39 
38 
36 
35 
34 
33 
32 
31 
30 
29 
29 
28 
27 
26 
26 
25 
24 
95.3 
 
47 
45 
44 
43 
41 
40 
38 
37 
36 
35 
34 
33 
32 
31 
30 
29 
29 
28 
27 
26 
26 
25 
97.7 
 
48 
47 
45 
44 
42 
41 
39 
38 
37 
36 
35 
34 
33 
32 
31 
30 
29 
28 
28 
27 
26 
26 
99.8 
 
49 
48 
46 
45 
43 
42 
40 
39 
38 
37 
36 
35 
34 
33 
32 
31 
30 
29 
28 
28 
27 
26 
102.3 
 
51 
49 
47 
46 
44 
43 
41 
40 
39 
38 
36 
35 
34 
33 
32 
31 
31 
30 
29 
28 
27 
27 
104.3 
 
52 
50 
48 
47 
45 
44 
42 
41 
40 
38 
37 
36 
35 
34 
33 
32 
31 
30 
30 
29 
28 
27 
106.8 
 
53 
51 
49 
48 
46 
44 
43 
42 
40 
39 
38 
37 
36 
35 
34 
33 
32 
31 
30 
29 
29 
28 
109.8 
 
54 
52 
50 
49 
47 
45 
44 
43 
41 
40 
39 
38 
37 
36 
35 
34 
33 
32 
31 
30 
29 
29 
111.4 
 
55 
53 
51 
50 
48 
46 
45 
43 
42 
41 
40 
38 
37 
36 
35 
34 
33 
32 
32 
31 
30 
29 
 

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IMS Health & Ocmnlcs ~re now 
=IOVIA~ 
'-'~ 
'~ SUNOVION 
Statistical Analysis Plan 
PROTOCOL D1052024 
Page 2 of 66 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE 
Statistical Analysis Plan V3.0 (Dated 11 APR2019) for Protocol D1052024. 
Name 
Signature 
Date 
Author: 
Position: 
Company .... 
IQVIA 
Upon review of this document, the undersigned approves this version of the Statistical Analysis Plan, 
authorizing that the content is acceptable for the reporting of this study. 
Name 
Signature 
Date 
Approved By: 
Position: 
Company: 
Approved By 
Sunovion Pharmaceuticals, Inc. 
Position: 
Company: 
Sunovion Pharmaceuticals, Inc. 
Document: 
Author: 
Version Number: 
Version Date: 
Final Draft 
11APR2019 
Template No: CS_TP _8S016 Revision 4 
Effective Date 01Apr2016 
Copyright© 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
Reference: CS_WI_BS005 


IMS He.t t, & Ou,nt1le1 arc now 
IQVIA~ 
~,~ 
?~ SUNOVION 
Statistical Analysis Plan 
PROTOCOL D1052024 
Page 3 of 66 
Approved By: 
Position: 
Company: 
Approved By: 
Position: 
Company: 
Sunovion Pharmaceuticals, Inc. ------ 
1..11 
Sunovion Pharmaceuticals, Inc. 
Document: 
Author: 
Version Number: 
Version Date: 
Final Draft 
11APR2019 
Template No: CS_ TP _BS016 Revision 4 
Effective Date 01Apr2016 
Copyright© 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
Reference: CS_WI_BS005 


Document Approval Signature(s) 
This document has been signed electronically in compliance with IQVIA and IQVIA 
Companies' electronic signature policies and procedures. This page is a manifestation of the 
electronic signatures, which may be confirmed within the IQVIA and IQVIA Companies' 
source system in accordance with IQVIA and IQVIA Companies' records retention policies. 
Note: the Title field in the signature block has been intentionally left blank.
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UserName: 
Title:  
Date: Friday, 12 April 2019, 10:57 AM   Eastern Time 
Meaning: I Approve the Document
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