A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Acute Schizophrenia
Phase: PHASE2
Conditions: Schizophrenia
Sponsor: LB Pharmaceuticals Inc.

CLINICAL STUDY PROTOCOL 
PROTOCOL TITLE: 
A Randomized, Double-blinded, Placebo-controlled, 
Multicenter Study to Evaluate the Antipsychotic 
Efficacy and Safety of LB-102 in the Treatment of 
Adult Patients with Acute Schizophrenia 
STUDY NUMBER: 
LB-102-003 
IND NUMBER: 
137581 
SPONSOR: 
LB Pharmaceuticals Inc 
575 Madison Avenue 
New York, NY 10022 
Phone: (646) 588-8175 
ORIGINAL PROTOCOL 
VERSION AND DATE: 
Final Version 1.0, 17 July 2023 
 
PREVIOUS PROTOCOL 
VERSION AND DATE: 
Final, Version 2.0, 23 November 2023  
 
AMENDED PROTOCOL 
VERSION AND DATE: 
NCT# 
Final, Version 3.0, 08 February 2024 
 
NCT06179108 
 
 
CONFIDENTIAL 
This document and its contents are the property of and confidential to LB Pharmaceuticals Inc. 
Any unauthorized copying or use of this document is prohibited. 
 
 
 

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SPONSOR APPROVAL FORM 
Protocol Title: A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to 
Evaluate the Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adult Patients 
with Acute Schizophrenia 
Study No: LB-102-003 
Original Protocol Version and Date: Version 1.0, 17 July 2023  
Previous Protocol Version and Date: Version 2.0, 23 Nov 2023 
Amended Protocol Version and Date: Version 3.0, 08 February 2024 
This study protocol was subject to critical review and has been approved by the appropriate 
protocol review committee of the Sponsor.  
The Investigator will be supplied with details of any significant or new findings, including 
adverse events, relating to treatment with the study drug. Any modifications of the clinical study 
protocol must be agreed upon by the Sponsor and the Investigator and must be documented in 
writing.  
 
 
Signature 
 
Date (DD/MMM/YYYY) 
  Anna Eramo, Chief Medical Officer, LB Pharmaceuticals Inc 
 
Signature 
 
Date (DD/MMM/YYYY) 
  Prof. John Kane, Principal Investigator 
 
Signature 
 
Date (DD/MMM/YYYY) 
  Niccolo Bassani, Senior Principal Biostatistician 
 
 

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LB-102-003 
A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to 
Evaluate the Antipsychotic Efficacy and Safety of LB-102 in the Treatment of 
Adult Patients with Acute Schizophrenia 
CONFIDENTIALITY AND INVESTIGATOR STATEMENT 
The information contained in this protocol and all other information relevant to LB102-003 are 
the confidential and proprietary information of LB Pharmaceuticals Inc and, except as may be 
required by federal, state, or local laws or regulation, may not be disclosed to others without 
prior written permission of LB Pharmaceuticals Inc. 
I have read the protocol, including all appendices, and I agree that it contains all of the necessary 
information for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein, in accordance with applicable national, state, and local regulations and will make 
a reasonable effort to complete the study within the time designated. 
I will provide all study personnel under my supervision copies of the protocol and any 
amendments, and access to all information provided by LB Pharmaceuticals Inc or specified 
designees. I will discuss the material with them to ensure that they are fully informed about LB 
Pharmaceuticals Inc and the study. 
 
 
Signature 
 
Date (DD/MMM/YYYY) 
 
 
Investigator Name (printed) 
 
Site Number 
 
 
 
 

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STUDY SYNOPSIS 
Protocol Title: 
A Randomized, Double-blinded, Placebo-controlled, Multicenter 
Study to Evaluate the Antipsychotic Efficacy and Safety of LB-102 
in the Treatment of Adult Patients with Acute Schizophrenia  
Study Number: 
LB-102-003 
Clinical Phase: 
Phase 2 
Investigator(s)/ 
Study Center(s): 
This study will be conducted in up to 25 study centers, with up to 
25 Investigators, located in the US. Worldwide Clinical Trials, a 
contract research organization, will oversee operational aspects of 
this study on behalf of LB Pharmaceuticals Inc, the Sponsor of the 
study. 
Objectives: 
The objectives of this study are as follows: 
Primary Objective 
• To determine whether N-methyl amisulpride (LB-102 
administered to patients with acutely exacerbated schizophrenia 
demonstrates antipsychotic efficacy, as determined by a change 
from Baseline on the Positive and Negative Syndrome Scale 
(PANSS) total score, compared to placebo. 
Secondary Objectives 
• To evaluate the safety and tolerability of LB-102 in patients with 
acutely exacerbated schizophrenia. 
• To assess the effect of LB-102 on the severity of illness in 
patients with acutely exacerbated schizophrenia, as determined by 
a change from Baseline in the Clinical Global 
Impressions-Severity of Illness scale (CGI-S) score. 
• To assess the effect of LB-102 on PANSS subscale and Marder 
Factor scores in patients with acutely exacerbated schizophrenia. 
Exploratory Objectives 
• To explore the effect of LB-102 on Cogstate test score. 
Study Design: 
This is a Phase 2 randomized, double-blind, placebo-controlled, fixed 
dose, multicenter study designed to assess the efficacy, safety, 
tolerability, and pharmacokinetics of LB-102 50 mg once daily (QD), 
LB-102 75 mg QD, and LB-102 100 mg QD versus placebo QD for 

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the treatment of adult patients with an acute exacerbation of 
schizophrenia. Approximately 350 patients will be randomized to 
receive 1 of 4 study treatments in a 3:3:3:1 ratio: placebo, LB-102 
50 mg, LB-102 75 mg, or LB-102 100 mg for 28 days. 
• Placebo group – up to 105 patients 
• LB-102 50 mg group – up to 105 patients 
• LB-102 75 mg group – up to 105 patients 
• LB-102 100 mg group – up to 35 patients 
Re-screening may be permitted on a case-by-case basis with the 
approval of LB Pharmaceuticals Inc and Medical Monitors.  
Study participation will last approximately 8 weeks and includes a 
7-day inpatient screening phase (up to a 7-day extension of the 
screening phase is allowed, if necessary, with the approval of the 
Medical Monitor), an inpatient Study Treatment Period with 4 weeks 
of daily study treatment, an inpatient Stabilization Period of up to 
5 days (during which patients will be stabilized on standard 
antipsychotic medication), and an outpatient Final Safety Follow-up 
of approximately 2 weeks after the end of the Treatment Period. 
Duration of 
Treatment: 
28-day inpatient Study Treatment Period. 
Planned Sample Size: Approximately 350 patients will be randomized into the study.  
Target Population: 
The patient population will include males and females, 18 to 55 years 
of age with a current diagnosis of schizophrenia as defined by criteria 
in the Diagnostic and Statistical Manual of Mental Disorders, Fifth 
Edition (DSM-5) and confirmed by the Mini International 
Neuropsychiatric Interview version 7.0.2 (MINI 7.0.2) for 
Schizophrenia and Psychotic Disorders, with a total PANSS score 
between 80 and 120 inclusive, and a score of ≥4 (moderate or 
greater) for ≥2 or more of the following Positive Scale (P) items: 
Item 1 (P1; delusions), Item 2 (P2; conceptual disorganization), Item 
3 (P3; hallucinatory behavior), Item 6 (P6; 
suspiciousness/persecution), and a score of ≥4 on the CGI-S. Eligible 
patients will include those who would benefit from hospitalization or 
continued hospitalization for the treatment of a current acute 
exacerbation of psychotic symptoms (defined as 6 weeks prior to 
Screening). 

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Eligibility Criteria: 
Inclusion Criteria 
Patients will be eligible for inclusion in the study if they meet all of 
the following criteria: 
1. Patient, who is able to provide written informed consent (as 
required by Institutional Review Board [IRB]) prior to the 
initiation of any protocol-required procedures. Ability, in the 
opinion of the Principal Investigator (PI), to understand the nature 
of the trial and follow protocol requirements, including the 
prescribed dosage regimens, tablet ingestion, and discontinuation 
of prohibited concomitant medication, and to be reliably rated on 
assessment scales. 
2. Must be willing to be hospitalized for the duration of the inpatient 
period of the study, and willing to comply with instructions from 
the Investigator and study staff. 
3. Have stable living environment when not in a hospital, as 
demonstrated by the ability to provide contact information for 
themselves or family/friend(s)/caregiver(s). 
4. Male and female patients 18 to 55 years of age inclusive at the 
time of informed consent with a diagnosis of schizophrenia as 
defined by DSM-5 criteria and confirmed by the MINI 7.0.2 for 
Schizophrenia and Psychotic Disorders Studies. 
5. Body mass index (BMI) must be ≥18 and ≤40 kg/m2. 
6. Patient who is:  
• experiencing an acute exacerbation of psychotic symptoms, 
with onset ≤6 weeks before Screening AND the patient 
requires hospitalization for this acute exacerbation of 
psychotic symptoms.  
OR  
• if already an inpatient at Screening, has been hospitalized for 
onset ≤2 weeks for the current exacerbation. 
7. Patients who are experiencing an acute exacerbation of psychotic 
symptoms and marked deterioration of usual function as 
demonstrated by meeting ALL of the following criteria at the 
Screening and Baseline visits: 
• Total PANSS score between 80 and 120, inclusive, and 

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• Score of ≥4 (moderate or greater) for ≥2 of the following 
Positive Scale (P) items: Item 1 (P1; delusions), Item 2 (P2; 
conceptual disorganization), Item 3 (P3; hallucinatory 
behavior), Item 6 (P6; suspiciousness/persecution), and 
• CGI-S score ≥4 (moderately to severely ill). 
8. Have received previous antipsychotic treatment (dose and 
duration as per the label) and who showed a previous good 
response to such antipsychotic treatment (other than clozapine) in 
the last 12 months, according to the Investigator’s opinion. 
9. Have history of relapse and/or exacerbation of symptoms when 
they were not receiving antipsychotic treatment, according to the 
Investigator’s opinion. 
10. Patients willing to discontinue all prohibited psychotropic 
medications prior to Screening, if determined to be clinically 
appropriate by the Investigator, and not for the sole purpose of 
inclusion in the trial.  
Exclusion Criteria 
Patients will be excluded from the study if they meet any of the 
following criteria: 
Sex and Reproductive Status 
1. Sexually active females of childbearing potential and male 
patients who are not practicing 2 different methods of birth 
control with their partner during the trial and for 30 days after the 
last dose of trial medication or who would not remain abstinent 
during the trial and for 30 days after the last dose. If employing 
birth control, each couple must use 2 of the following 
precautions: oral contraceptives, patch contraceptives, injection 
contraceptives, implantable hormonal contraceptives, male 
condom with intravaginal spermicide, diaphragm or cervical cap 
with spermicide, vaginal contraceptive ring, intrauterine device or 
system, surgical sterilization (hysterectomy, bilateral 
oophorectomy, and/or bilateral salpingectomy), tubal 
ligation/occlusion, vasectomized partner, or sexual abstinence, if 
this is the patient’s current practice. Contraceptive requirements 
do not apply to patients who are in same sex relationship, who are 
medically or surgically sterilized (e.g., bilateral tubal ligation, 
bilateral oophorectomy, hysterectomy); or practice sexual 
abstinence during this study. 

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2. Females who are breastfeeding or who have a positive pregnancy 
test result prior to receiving trial medication. 
Target Disease 
3. Patients who presented with a first episode of schizophrenia 
based on the clinical judgment of the Investigator and patients 
with diagnosed schizophrenia equal to or less than a year. 
4. Improvement of ≥20% in total PANSS score between the 
Screening and Baseline assessments. 
5. History of treatment resistance to schizophrenia medications 
defined as failure to respond to 2 adequate courses of 
pharmacotherapy (dose and duration as per the label) or required 
clozapine within the last 12 months. 
6. Current DSM-5 Axis I diagnosis other than schizophrenia 
including, but not limited to, schizoaffective disorder, major 
depressive disorder, bipolar disorder, post-traumatic stress 
disorder, anxiety disorders, delirium, dementia, amnestic or other 
cognitive disorders, as determined by the MINI 7.0.2. Also, 
patients with borderline, paranoid, histrionic, schizotypal, 
schizoid, or antisocial personality disorder, as determined by the 
MINI 7.0.2 and Mini International Neuropsychiatric Interview 
with Borderline Personality Disorder Module version 7.0.2 
(MINI-Plus BPD 7.0.2). 
7. Risk for suicidal behavior during the study as determined by the 
Investigator’s clinical assessment and Columbia-Suicide Severity 
Rating Scale (C-SSRS) as confirmed by the following: answers 
“Yes” on items 4 or 5 (C-SSRS – Ideation) with the most recent 
episode occurring within the 6 months before Screening, or 
answers “Yes” to any of the 5 items (C-SSRS – Suicidal 
Behavior) with an episode occurring within the 12 months before 
Screening. This assessment will be repeated at Baseline Visit (at 
baseline “Since Last Visit” version of the CSSR-S scale should 
be used). Non-suicidal self-injurious behavior is not exclusionary. 
8. Risk of violent or destructive behavior based on the Investigator’s 
opinion and homicidal ideation based on responses to 
SCI- PANSS interview questions or statements made by the 
patient at any other times during the Screening or Baseline visits. 
9. Patients with clinically significant tardive dyskinesia determined 
by a score of ≥3 on Item 8 of the Abnormal Involuntary 
Movement Scale (AIMS) at Screening. 

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10. Patients with a score of ≥3 on the Barnes Akathisia Rating Scale 
(BARS) global clinical assessment of akathisia at Screening. 
Medical History and Concurrent Diseases 
11. Patients who met DSM-5 criteria for substance abuse or 
dependence within the past 1 year, including alcohol and 
benzodiazepines, but excluding caffeine and nicotine. Previous 
occasional use of alcohol or cannabis is allowed as long as the 
level of use does not meet DSM-5 criteria for any moderate or 
severe substance use disorder within the 12 months prior to 
Screening, and the use of alcohol or cannabis is not considered to 
be the precipitating factor of the current psychotic episode in the 
opinion of the Investigator; subjects are required to abstain from 
alcohol and cannabis use during the trial. 
12. Patients with hypothyroidism or hyperthyroidism (unless the 
condition had been stabilized with medications for at least the 
past 90 days) and/or clinically significant abnormal thyroid 
function (abnormal thyroid-stimulating hormone [TSH] levels 
followed by free T3 and T4 levels), as assessed by the 
Investigator, in discussion with the study Medical Monitor.  
13. History or presence of clinically significant cardiovascular, 
pulmonary, hepatic, renal, hematologic, gastrointestinal, 
endocrine, immunologic, dermatologic, neurologic, or oncologic 
disease or any other condition that, in the opinion of the 
Investigator, would jeopardize the safety of the subject or the 
validity of the study results. Positive result at Screening for 
hepatitis B surface antigen (HbsAg), hepatitis C virus, or human 
immunodeficiency virus- (HIV)-1 or -2. Patients with chronic 
hepatitis B or hepatitis C may be included after discussion with 
the Medical Monitor provided that their condition is stable and 
values for liver function test meet the specified criteria of alanine 
aminotransferase (ALT) and aspartate aminotransferase (AST) 
<2 × upper limit of normal (ULN). The Medical Monitor should 
be contacted in any instance where the Investigator is uncertain 
regarding the stability of a patient’s medical condition(s) and the 
potential impact of the condition(s) on trial participation. 
14. Patients with insulin-dependent diabetes mellitus (i.e., any patient 
using insulin) are excluded. Patients with non-insulin-dependent 
diabetes mellitus may be eligible for the trial if their condition is 
stable as determined by satisfying ALL of the following criteria: 
• Glycosylated hemoglobin (HbA1c) <7.0%, and 

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• Screening glucose must have been ≤125 mg/dL or 
≤6.94 mmol/L (fasting) or <200 mg/dL or <11.1 mmol/L 
(non-fasting). If the non-fasting Screening glucose was 
≥200 mg/dL or ≥11.1 mmol/L, patients must have been 
retested in a fasted state and the retest value must have been 
≤125 mg/dL or ≤6.94 mmol/L, and 
• Patient had been maintained on a stable regimen of oral 
antidiabetic medication(s) for at least 28 days prior to 
Screening or diabetes had been well controlled by diet for at 
least 28 days prior to Screening, and 
• Patient had no hospitalizations within the 12 months prior to 
Screening due to diabetes or complications related to 
diabetes, and 
• Patient’s diabetes should not be newly diagnosed during 
Screening for the trial. 
15. Patients with uncontrolled hypertension (diastolic blood pressure 
[DBP] >95 mmHg or systolic blood pressure [SBP] >145 mmHg 
in any position) or symptomatic hypotension, or orthostatic 
hypotension defined as a decrease of ≥20 mmHg in SBP and/or a 
decrease of ≥10 mmHg in DBP after at least 3 minutes standing 
compared with the previous supine blood pressure, OR 
development of symptoms. NOTE: Blood pressure measurements 
may be repeated once to ensure reproducibility of the 
exclusionary result(s) before excluding a patient based on the 
criteria noted above. 
16. Patients with known ischemic heart disease or any history of 
myocardial infarction, congestive heart failure (whether 
controlled or uncontrolled), angioplasty, stenting, or coronary 
artery bypass surgery. 
17. Patients with epilepsy or a history of seizures (with the exception 
of febrile seizure). 
Physical and Laboratory Results 
18. Patients with a positive urine drug screen or a positive blood 
alcohol test. Detectable levels of marijuana, barbiturates, 
benzodiazepines or opiates in the drug screen are not 
exclusionary if, in the Investigator’s documented opinion, the 
patient does not meet DSM-5 criteria for substance abuse or 

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dependence, in the Investigator’s documented opinion, the 
positive test does not signal a clinical condition that would impact 
the safety of the patient or interpretation of the trial results, and 
approval was granted by the Medical Monitor prior to treatment.  
19. Patients with a history of alcohol use disorder, substance use 
disorder (by DSM-5 criteria) within 12 months of Screening or a 
positive screen for drugs of abuse at Screening (unless consistent 
with current prescription for medical condition). 
20. The following laboratory test results are exclusionary:  
• Platelets ≤75,000/µL or ≤75×109/L 
• Hemoglobin ≤9 g/dL or ≤90 g/L 
• Neutrophils, absolute ≤1000/µL or ≤1×109/L 
• AST >2 × ULN 
• ALT >2 × ULN 
• Creatine phosphokinase >3 × ULN, unless discussed with and 
approved by the Medical Monitor 
• Creatinine ≥2 mg/dL or ≥176.8 µmol/L 
• Estimated neytrine clearance of <45 mL/min, calculated using 
the Cockcroft-Gault equation, at Screening 
• HbA1c ≥7.0%  
• Abnormal free T4 (during Screening), unless discussed with 
and approved by the Medical Monitor (Note: Free T4 will be 
measured only if the result for TSH is abnormal).  
21. Clinically significant abnormal finding on the triplicate set of 
electrocardiograms (ECGs) or evidence of any of the following 
cardiac conduction abnormalities at Screening (mean values will 
be used for the following criteria): 
• Heart rate <40 beats per minute (bpm) and >110 bpm (based 
on the ECG reading). NOTE: The Medical Monitor should be 
contacted in any instance where the Investigator is uncertain 
regarding the stability of a patient’s medical condition(s) and 
the potential impact of the condition(s) on trial participation 

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• Interval between Q and T wave corrected for heart rate using 
Fridericia’s formula (QTcF) interval >450 msec for males and 
females 
• PR interval ≥200 msec 
• Intraventricular conduction delay with QRS duration 
>120 msec 
• Evidence of second- or third-degree atrioventricular block 
• Electrocardiographic evidence of complete left bundle branch 
block (LBBB), complete right bundle branch block (RBBB), 
or incomplete LBBB 
Prohibited Therapies or Medications 
22. Patients who are currently taking oral antipsychotic medications, 
monoamine oxidase inhibitors (MAOIs), anticonvulsants (e.g., 
lamotrigine, Depakote), tricyclic antidepressants (e.g., 
imipramine, desipramine), selective serotonin reuptake inhibitors, 
and any other antidepressants or any other psychoactive 
medications (except lorazepam, zolpidem, zaleplon, eszopiclone, 
or similar benzodiazepines, diphenhydramine, benztropine, and 
propranolol). Patients taking prohibited psychotropic medications 
may be eligible for inclusion in the study if it is clinically 
appropriate to discontinue the medication before the Baseline 
Visit (in the opinion of the Investigator). The prohibited 
psychotropic agent must be discontinued and washed out at least 
5 half-lives prior to Baseline. Subjects taking a depot 
antipsychotic could not have received a dose of medication for at 
least 1 and a half injection cycles before Baseline. The 
medications should not be discontinued solely to make the patient 
eligible for enrollment in the study. 
23. Patients who received electroconvulsive therapy within 90 days 
of Screening. 
24. Patients who received Transcranial Magnetic Stimulation (TMS) 
within 90 days of Screening. 
Allergies and Adverse Drug Reactions 
25. Patients with a history of neuroleptic malignant syndrome. 
26. Patients with a history of allergic response (defined as 
hypersensitivity reactions such as flushing, rash, wheezing, 

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abdominal cramps, hypotension, seizure, etc., not intolerance) to 
more than 1 class of medications. 
Others 
27. Prisoners or patients who were compulsorily detained 
(involuntarily hospitalized) for treatment of either a psychiatric or 
physical illness or have been in the last 6 months prior to the 
Screening Visit must not be enrolled into this study. 
28. Patients who have participated in another clinical study in which 
they received an experimental or investigational drug agent 
within 3 months of Screening.  
Study Drug(s): 
Approximately 350 patients will be randomized to receive 1 of 4 
study treatments in a 3:3:3:1 ratio: placebo, LB-102 50 mg QD, 
LB-102 75 mg QD, or LB-102 100 mg QD for 28 days. LB-102 and 
placebo will be administered as visually matched tablets for the 
treatment of adult patients with an acute exacerbation of 
schizophrenia. LB-102 tablets are 50 mg in strength. The placebo 
tablets will match the 50-mg tablets in appearance. Tablet-splitting 
procedures are outlined in the Pharmacy Manual. The following 
tablets will be administered based on randomization: 
Dose  
Number of 
Active tablets 
Number of 
Placebo Tablets 
Total Number of 
Tablets per Dose 
Placebo 
0 
2.5 
2.5 
50 mg 
1 
1.5 
2.5 
75 mg 
1.5 
1 
2.5 
100 mg 
2 
0.5 
2.5 
Primary Endpoint: 
The primary endpoint is the change from Baseline to Week 4 in the 
PANSS total score, compared to placebo 
Secondary 
Endpoints: 
Secondary efficacy endpoints will be as follows: 
• Change from Baseline to Week 4 in the CGI-S score 
• Change from Baseline to Week 4 in PANSS positive subscale 
score 
• Change from Baseline to Week 4 in PANSS negative subscale 
score 
• Change from Baseline to Week 4 in PANSS Marder Factor scores 
• Response rate, defined as 

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o Reduction of ≥20% from Baseline in PANSS total score at 
Week 4 
Exploratory 
Endpoint: 
• Effect of LB-102 on Cogstate test score 
Safety Outcome 
Measures: 
Safety will be assessed by the following: 
• AE reporting 
• Physical examination 
• Vital signs 
• Body weight, BMI; derived programmatically from body weight 
and height measurements), and waist circumference 
• Clinical laboratory tests (hematology, serum chemistry [including 
prolactin], urinalysis, and pregnancy tests); prothrombin time 
(PT), activated partial thromboplastin time (aPTT), international 
normalized ratio (INR), HbA1c, cortisol, adrenocorticotropic 
hormone (ACTH), TSH and total cholesterol, triglycerides, high-
density lipoprotein (HDL) and low-density lipoprotein (LDL) 
• 12-lead ECGs 
• Assessments of extrapyramidal side effects (EPS): the Simpson-
Angus Scale (SAS), the AIMS, the BARS 
• Columbia-Suicide Severity Rating Scale (C-SSRS) 
Pharmacokinetic 
Analyses 
PK analyses will include the first 60 patients randomized in the study 
regardless of cohort. PK blood samples will be collected on Day 1, 8, 
and 21 at the following timepoints after the morning dose: 15 
minutes, 30 minutes, 1, 2, 3, 4, 8, and 24 hours. On Day 1 only, a 
pre-dose PK blood sample will be collected.  
Statistical 
Procedures: 
Approximately 350 patients will be randomized in a 3:3:3:1 ratio to 
placebo, LB-102 50 mg QD, LB-102 75 mg QD, or LB-102 100 mg 
QD, respectively, with 105 patients randomized to the first 3 arms 
and 35 to the last one (LB-102 100 mg). This will ensure at least 85% 
power at a 2-sided 5% significance level to detect a treatment 
difference on the primary endpoint of 8 between either LB-102 
50 mg or 75 mg and placebo QD, assuming a common standard 
deviation (SD) of 18, an overall drop-out rate of 25% and a Hochberg 

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procedure to adjust for multiplicity. The sample size was estimated 
via Monte Carlo simulations using 10,000 simulated trials. 
A formal and detailed statistical data analysis plan will be prepared 
before database lock. The primary endpoint will be the change from 
Baseline to Week 4 on the PANSS total score. Formal statistical 
testing for comparison of the LB-102 50 mg and 75 mg treatment 
groups to placebo will be performed for the primary endpoint only, 
using appropriate procedures for multiplicity adjustment. In addition, 
descriptive statistics for safety, efficacy, and PK variables will be 
provided for all treatment groups. Shift tables for safety parameters 
will be prepared for appropriate categorical variables and change 
from Baseline and effect sizes will be calculated for efficacy 
measures. 
The primary efficacy analysis will be performed using a Mixed 
Model for Repeated Measures (MMRM) using the modified Intent-
to-Treat population as analysis set. The model will include treatment, 
site, visit, and treatment by visit interaction as categorical covariates 
and Baseline PANSS as continuous covariate. Within-patient 
correlation will be accounted for using an unstructured correlation. A 
similar model will be considered for continuous secondary endpoints. 
The response rate endpoint will be analyzed using a logistic 
regression model with treatment as categorical covariate and Baseline 
PANSS total score as continuous covariate. 
Safety: Safety variables to be examined in this study will include 
AEs, physical examinations, vital signs, body weight, BMI (derived 
programmatically from body weight and height measurements), waist 
circumference, clinical laboratory tests (hematology, serum 
chemistry [including prolactin]), urinalysis, pregnancy tests, PT, 
aPTT, INR, HbA1c, cortisol, ACTH, TSH, total cholesterol, 
triglycerides, HDL, and LDL, ECGs, and an evaluation of 
extrapyramidal symptoms using the SAS, AIMS, and BARS. The 
C-SSRS will be used to assess and classify reported suicidal 
behavior.  
Pharmacokinetics: Plasma concentrations of LB-102 and metabolites 
(including amisulpride) will be measured during the study and PK 
parameters derived using noncompartmental or compartmental 
methods as appropriate. The following PK parameters (as 
appropriate) will be calculated: area under the concentration-time 
curve from time zero to time (AUC0-t), area under the concentration-
time curve from time of dosing up to 24 hours (AUC0-24), area under 
the concentration-time curve from time zero to infinity (AUC0-inf), 
area under the concentration-time curve extrapolated from time t to 
infinity as a percentage of the total AUC (AUC%extrap), oral clearance 

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(CL/F), maximum concentration (Cmax), time to reach Cmax (Tmax), 
terminal elimination rate constant (λz), and apparent terminal half-life 
(t½). 
No value for λz, AUC0-inf, CL/F, or t½ will be reported for cases that 
do not exhibit a terminal log-linear phase in the concentration versus 
time profile. 
No PK parameters will be calculated for patients with no detectable 
concentrations for 2 or fewer time points. 
Individual and mean plasma concentration-time curves (both linear 
and log-linear) will be included in the final report. 
PK parameters of LB-102 and metabolites will be summarized by 
cohort using descriptive statistics (sample size, arithmetic means, 
geometric means, SD, % coefficient of variation, minimum, median, 
and maximum). Figures will be created to display mean and 
individual patient LB-102 and amisulpride concentration-time curves 
in plasma on both a linear and logarithmic scale. Dose 
proportionality will be assessed using linear regression, or another 
acceptable approach. 

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TABLE OF CONTENTS 
CLINICAL STUDY PROTOCOL ...............................................................................................1 
SPONSOR APPROVAL FORM ..................................................................................................2 
CONFIDENTIALITY AND INVESTIGATOR STATEMENT ...............................................3 
STUDY SYNOPSIS .......................................................................................................................4 
TABLE OF CONTENTS ............................................................................................................17 
LIST OF TABLES .......................................................................................................................20 
LIST OF FIGURES .....................................................................................................................20 
LIST OF ABBREVIATIONS .....................................................................................................21 
1 
INTRODUCTION AND RATIONALE .............................................................................26 
1.1 
Background ......................................................................................................................26 
1.2 
Current Treatment Options for Schizophrenia ............................................................26 
1.3 
Background on LB-102 ...................................................................................................26 
1.4 
Summary of Clinical Experience, Pharmacology, and Safety .....................................27 
1.5 
Study Rationale ................................................................................................................29 
1.6 
Dose Rationale ..................................................................................................................29 
1.7 
Study Endpoint Rationale ...............................................................................................30 
1.8 
Risks and Benefits for Patients .......................................................................................30 
1.8.1 
Risks ............................................................................................................................30 
1.8.2 
Benefits ........................................................................................................................30 
2 
STUDY OBJECTIVES ........................................................................................................31 
2.1 
Primary Objective ............................................................................................................31 
2.2 
Secondary Objectives.......................................................................................................31 
2.3 
Exploratory Objectives ....................................................................................................31 
3 
STUDY ENDPOINTS ..........................................................................................................32 
3.1 
Primary Endpoint ............................................................................................................32 
3.2 
Secondary Efficacy Endpoints ........................................................................................32 
3.3 
Exploratory Endpoint ......................................................................................................32 
3.4 
Safety Endpoints ..............................................................................................................32 
4 
STUDY PLAN .......................................................................................................................34 
4.1 
Study Design .....................................................................................................................34 
4.1.1 
Stopping Criteria .......................................................................................................36 
4.2 
Study Duration .................................................................................................................36 
4.3 
Safety Review Committee ................................................................................................36 
5 
STUDY POPULATION .......................................................................................................37 
5.1 
Inclusion Criteria .............................................................................................................37 
5.2 
Exclusion Criteria ............................................................................................................38 
5.3 
Patient Withdrawal/Discontinuation Criteria ...............................................................43 
6 
STUDY TREATMENT AND MANAGEMENT ...............................................................46 
6.1 
Description ........................................................................................................................46 
6.1.1 
Formulation and Preparation ...................................................................................46 
6.1.2 
Labeling ......................................................................................................................47 
6.1.3 
Storage ........................................................................................................................47 
6.2 
Shipment, Blinding, and Unblinding ..............................................................................47 
6.2.1 
Shipment .....................................................................................................................47 
6.3 
Treatment Assignment ....................................................................................................47 

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6.3.1 
Blinding and Unblinding Treatment Assignments .................................................48 
6.4 
Dose and Administration .................................................................................................48 
6.5 
Accountability ..................................................................................................................49 
6.6 
Treatment Compliance ....................................................................................................49 
6.7 
Prior and Concomitant Medications ..............................................................................49 
6.7.1 
Acceptable Contraceptive Methods ..........................................................................52 
7 
STUDY CONDUCT ..............................................................................................................53 
7.1 
Schedule of Assessments ..................................................................................................53 
7.2 
Study Procedures by Time Point ....................................................................................58 
7.2.1 
Visit 1 (Screening – up to 7 Days) .............................................................................58 
7.2.2 
Visit 2 (Baseline, Study Day 1) ..................................................................................59 
7.2.3 
Study Days 2 Through 7 ............................................................................................60 
7.2.4 
Visit 3 (Study Day 8) ..................................................................................................60 
7.2.5 
Study Days 9 Through 14 ..........................................................................................61 
7.2.6 
Visit 4 (Study Day 15) ................................................................................................61 
7.2.7 
Study Days 16 Through 20 ........................................................................................61 
7.2.8 
Visit 5 (Study Day 21) ................................................................................................62 
7.2.9 
Study Days 22 Through 27 ........................................................................................62 
7.2.10 
Visit 6 (Study Day 28) ................................................................................................62 
7.2.11 
Stabilization Period (Study Days 29 Through 33) ..................................................63 
7.2.12 
Visit 7 (Study Day 33) ................................................................................................63 
7.2.13 
Visit 8 (End of Study) ................................................................................................64 
7.2.14 
Study Procedures for Early Termination and Withdrawal ...................................64 
8 
DESCRIPTION OF ASSESSMENTS ................................................................................66 
8.1 
Efficacy Assessments .......................................................................................................66 
8.1.1 
Screening Assessments...............................................................................................66 
8.2 
Safety Assessments ...........................................................................................................67 
8.2.1 
Physical Examination and Height ............................................................................67 
8.2.2 
Vital Signs and Body Weight ....................................................................................68 
8.2.3 
Electrocardiogram .....................................................................................................68 
8.2.4 
Clinical Laboratory Tests..........................................................................................68 
8.2.5 
Adverse Events ...........................................................................................................69 
8.2.6 
Simpson-Angus Scale .................................................................................................69 
8.2.7 
Barnes Akathisia Rating Scale ..................................................................................69 
8.2.8 
Abnormal Involuntary Movement Scale .................................................................70 
8.2.9 
Columbia-Suicide Severity Rating Scale .................................................................70 
8.3 
Pharmacokinetic Assessments ........................................................................................71 
9 
ADVERSE EVENT REPORTING .....................................................................................73 
9.1 
Definitions and Criteria ...................................................................................................73 
9.1.1 
Adverse Events ...........................................................................................................73 
9.1.2 
Serious Adverse Events .............................................................................................73 
9.1.3 
Unexpected Adverse Drug Reactions .......................................................................74 
9.1.4 
Clinical Laboratory Changes ....................................................................................74 
9.1.5 
Assessment of Severity ...............................................................................................75 
9.1.6 
Assessment of Relationship .......................................................................................75 
9.1.7 
Action Taken Regarding Study Drug ......................................................................76 

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9.1.8 
Other Action Taken for Event ..................................................................................76 
9.1.9 
Adverse Event Outcome ............................................................................................76 
9.2 
Reporting Procedures and Requirements .....................................................................77 
9.2.1 
Adverse Events ...........................................................................................................77 
9.2.2 
Serious Adverse Events .............................................................................................77 
9.2.3 
Pregnancy During the Study .....................................................................................79 
10 STATISTICS .........................................................................................................................80 
10.1 
General Procedures .........................................................................................................80 
10.2 
Sample Size .......................................................................................................................80 
10.3 
Analysis Populations ........................................................................................................80 
10.4 
Statistical Methods ...........................................................................................................81 
10.4.1 
Protocol Deviations ....................................................................................................81 
10.4.2 
Patient Disposition .....................................................................................................81 
10.4.3 
Demographic and Baseline Characteristics .............................................................81 
10.4.4 
Analysis of Efficacy ....................................................................................................81 
10.4.5 
Analysis of Safety .......................................................................................................84 
10.4.6 
Pharmacokinetics .......................................................................................................86 
10.4.7 
Interim Analysis .........................................................................................................86 
11 STUDY MANAGEMENT AND RESPONSIBILITIES ...................................................87 
11.1 
Ethics .................................................................................................................................87 
11.1.1 
Good Clinical Practice ...............................................................................................87 
11.1.2 
Institutional Review Board .......................................................................................87 
11.1.3 
Informed Consent ......................................................................................................87 
11.1.4 
Confidentiality ............................................................................................................87 
11.2 
Auditing and Monitoring ................................................................................................87 
11.3 
Data Handling, Documentation, and Record Keeping .................................................88 
11.3.1 
Source Documentation...............................................................................................88 
11.3.2 
Direct Access to Source Data and Documents .........................................................88 
11.3.3 
Record Retention .......................................................................................................89 
11.3.4 
Study Documentation ................................................................................................89 
11.4 
Indemnification ................................................................................................................89 
11.5 
Amendments .....................................................................................................................89 
11.6 
Study Discontinuation .....................................................................................................89 
12 PUBLICATION POLICY ....................................................................................................90 
13 REFERENCES .....................................................................................................................91 
14 APPENDICES .......................................................................................................................92 
14.1 
Names of Study Personnel ...............................................................................................92 
14.2 
Phase 1 Clinical Data .......................................................................................................93 
14.2.1 
Phase 1 LB-102-001 - Completed..............................................................................93 
14.3 
Exclusionary Laboratory Results for Screening ...........................................................98 
14.4 
Half-Life of Major Psychiatric Medications ................................................................100 
 
 
 

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LIST OF TABLES 
Table 6.1: 
Details of Study Drug...........................................................................................46 
Table 6.2: 
Permitted concomitant medications ...................................................................50 
Table 6.3: 
Selected CYP2D6 Inhibitors and CYP3A4 Inhibitors and Inducers 
Prohibited During the Trial ................................................................................51 
Table 7.1: 
Schedule of Assessments ......................................................................................54 
Table 14.1: 
Summary of Key Plasma LB-102 Pharmacokinetic Parameters – 
Pharmacokinetic Population ...............................................................................96 
Table 14.2: 
Important Exclusionary Criteria for Screening ................................................98 
 
LIST OF FIGURES 
Figure 1.1: 
Striatal dopamine RO from single dose cohorts of LB-102-002 ......................28 
Figure 1.2: 
Striatal dopamine RO from single dose cohorts of LB-102-002 ......................29 
Figure 4.1: 
Study Schematic ...................................................................................................35 
 
 

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LIST OF ABBREVIATIONS 
 
Abbreviation 
Definition 
5HT7 
5-hydroxytryptamine (serotonin) receptor 7 
ACTH 
adrenocorticotropic hormone 
ADR 
adverse drug reaction 
AE 
adverse event 
AIMS 
Abnormal Involuntary Movement Scale 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
ANCOVA 
Analysis of Covariance 
API 
Active Pharmaceutical Ingredient 
aPTT 
activated partial thromboplastin time 
AST 
aspartate aminotransferase 
AUC 
area under the curve 
AUC0-12 
area under the concentration-time curve from time of dosing up to 12 hours 
AUC0-24 
area under the concentration-time curve from time of dosing up to 24 hours 
AUC0-inf 
area under the concentration-time curve from time zero to infinity 
AUC0-t 
area under the concentration-time curve from time zero to time 
AUC%extrap 
area under the concentration-time curve extrapolated from time t to infinity as a 
percentage of the total AUC 
AVB 
atrioventricular block 
BARS 
Barnes Akathisia Rating Scale 
BID 
twice daily 
BMI 
body mass index 
BPD 
Borderline Personality Disorder  
bpm 
beats per minute 
CGI-S 
Clinical Global Impressions-Severity of Illness scale 
CI 
confidence interval 
CL/F 
oral clearance 
CLss/F 
apparent clearance at steady state  
Cmax 
maximum concentration 
Cmin 
minimum concentration 

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Abbreviation 
Definition 
CMO 
chief medical officer 
CPK 
creatine phosphokinase 
CRO 
contract research organization 
CSR 
clinical study report 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
CV 
coefficient of variation 
CYP 
cytochrome p450 
d 
day(s) 
D2 
dopamine receptor 2 
D3 
dopamine receptor 3 
DBP 
diastolic blood pressure 
DSM-5 
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
electronic data capture 
EIU 
exposure in utero 
EPS 
extrapyramidal side effects 
EoS 
end of study 
EoT 
end of treatment 
ET 
early termination 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
h 
hour(s) 
HbA1c 
glycosylated hemoglobin 
HDL 
high-density lipoprotein 
HIV 
human immunodeficiency virus 
IB 
Investigator’s Brochure 
ICE 
intercurrent event 
ICF 
informed consent form 
ICH 
International Council for Harmonization of Technical Requirements for 
Pharmaceuticals for Human Use 
IND 
investigational new drug 
INR 
international normalized ratio 

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Abbreviation 
Definition 
IRB 
Institutional Review Board 
IRT 
Integrated response technology 
ITT 
intent-to-treat 
IU 
international units 
IXRS 
interactive response system 
LB-102 
N-methyl amisulpride 
LBBB 
left bundle branch block 
LDL 
low-density lipoprotein 
LLOQ 
lower limit of quantification 
LS 
least squares 
λz 
terminal elimination rate constant 
MAD 
multiple ascending doses 
MAR 
Missing At Random 
MD 
medical doctor 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
milligram 
min 
minute(s) 
MI 
Multiple Imputation 
MINI 7.0.2 
Mini International Neuropsychiatric Interview version 7.0.2 
MINI-Plus 7.0.2 
Mini International Neuropsychiatric Interview-Plus version 7.0.2 
MINI-Plus BPD 
7.0.2 
MINI International Neuropsychiatric Interview with Borderline Personality 
Disorder Module version 7.0.2 
mITT 
modified Intent-to-Treat 
MMRM 
Mixed Model for Repeated Measures 
MNAR 
Missing Not At Random 
MTD 
maximum tolerated dose 
ng/mL 
nanogram per milliliter 
OTC 
over-the-counter 
PANSS 
Positive and Negative Syndrome Scale 
PCRS 
Placebo-Control Reminder Script 
PD 
protocol deviation 
PET 
positron emission tomography 
PhD 
Doctor of Philosophy 

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Abbreviation 
Definition 
PI 
Principal Investigator 
PK 
pharmacokinetic 
PP 
per-protocol 
PR 
interval between the beginning of the P wave and the beginning of the next QRS 
complex 
PT 
prothrombin time 
QD 
once daily 
QRS 
duration of ventricular depolarization and contraction interval 
QT 
interval between Q and T wave 
QTcF 
interval between Q and T wave corrected for heart rate using Fridericia’s formula 
RAUC 
ratio AUC after the first and last dose 
RBBB 
right bundle branch block 
RBC 
red blood cells 
RCmax 
accumulation ratio based on Cmax after the first dose and last dose  
RO 
receptor occupancy 
RR 
interval between 2 R waves on the electrocardiogram tracing 
SAD 
Single Ascending Dose 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SAS 
Simpson-Angus Scale 
SBP 
systolic blood pressure 
SCI-PANSS 
Structured Clinical Interview for the Positive and Negative Syndrome Scale 
SD 
standard deviation 
SGAs 
second generation antipsychotics  
SoA 
schedule of assessments 
SOC 
system organ class 
SOP 
standard operating procedure 
SRC 
Safety Review Committee 
SS 
steady state 
t½ 
apparent terminal half-life 
TEAE 
treatment-emergent adverse event 
Tmax 
time to reach Cmax 
TSH 
thyroid-stimulating hormone 

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Abbreviation 
Definition 
ULN 
upper limit of normal 
UK 
United Kingdom 
US 
United States 
VCT 
Verified Clinical Trials 
WBC 
White blood cells 
Worldwide 
Worldwide Clinical Trials 
 
 
 

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1 INTRODUCTION AND RATIONALE 
1.1 
Background 
Schizophrenia is a chronic and debilitating mental illness that affects approximately 1% of the 
population. Hallucinations and delusions are the most striking characteristic positive symptoms 
of schizophrenia; however, more subtle negative symptoms (e.g., social withdrawal and lack of 
emotion, energy, and motivation) may also be present. Patients with schizophrenia have a 
3.5 times higher rate of mortality compared to the general population.1 A study in 2013 of over 
6 million Swedish adults (including 8300 patients with schizophrenia) found that females and 
males with schizophrenia died 12 and 15 years earlier than their counterparts in the general 
population, respectively.1 Schizophrenia patients suffer a profoundly reduced quality of life and 
are 10 times more likely to commit suicide than the general population.1 Half of the suicides 
among patients with schizophrenia occur within the first 2 years of disease onset,1 pointing to the 
urgency for behavioral and pharmaceutical intervention. Schizophrenia is a lifelong disease for 
the majority of patients. The course of schizophrenia is highly variable with periods of psychosis 
and stabilization of varying duration and intensity. Sustained remission of both positive and 
negative symptoms occurs in a minority of patients even with prolonged antipsychotic therapy. 
Many patients, even when stable, suffer disability due to the cognitive impairments that occur 
despite adequate antipsychotic therapy. Compliance with long-term medication is a significant 
problem due to dissatisfaction with antipsychotic side effects or self-discontinuation of 
medication as a result of feeling better and no longer perceiving the need for continuous 
medication. Both of these issues contribute to relapse among schizophrenia patients.1 
1.2 
Current Treatment Options for Schizophrenia 
There are currently 26 Food and Drug Administration (FDA) approved drugs to treat 
schizophrenia, all of which rely on dopamine inhibition to at least a degree. Despite the plethora 
of approved drugs most schizophrenia patients do not experience adequate resolution of their 
symptoms and switching medication or, worse, going off medication is common. Common side 
effects of schizophrenia drugs include extrapyramidal side effects (EPS), interval between Q and 
T wave (QT) prolongation, sedation, and weight gain. In preclinical and clinical studies LB-102 
demonstrated greater dopamine receptor occupancy (RO) than equivalent doses of amisulpride 
which could translate into a better tolerated drug. 
1.3 
Background on LB-102 
LB-102 (4-methylamino-N-((1-ethyl-2-pyrrolidinyl)methyl)-5-(ethylsulfonyl))-2-
methoxybenzamide) was designed to be an improved version of the safe and effective benzamide 
antipsychotic amisulpride by increasing its permeability across the blood-brain-barrier.1 This 
potentially decreases the plasma concentrations needed to achieve efficacy, thereby decreasing 
the magnitude and frequency of adverse events (AEs) typically observed in patients treated with 
amisulpride.1 In vitro studies have confirmed that N-methyl amisulpride (LB-102) is better able 
than amisulpride to passively penetrate a Parallel Artificial Membrane Permeability Assay 
membrane and exhibits similar activity and selectivity toward central nervous system receptors 
(dopamine receptor 2 [D2], dopamine receptor 3 [D3], and 5-hydroxytryptamine (serotonin) 
receptor 7 [5HT7]) as amisulpride.1 In vivo studies have demonstrated that LB-102 has a 

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favorable pharmacokinetic (PK) profile in rats and mice, similar to amisulpride, as well as a 
similar or superior efficacy to amisulpride in animal models (apomorphine induced climbing, 
novel object recognition, and locomotor activity) covering 3 aspects of schizophrenia.1  
In summary, LB-102 is a proprietary molecule having similar physicochemical and biological 
characteristics equivalent to or better than amisulpride, an antipsychotic with an established 
decades-long clinical track record. 
1.4 
Summary of Clinical Experience, Pharmacology, and Safety 
LB-102 was well tolerated with all treatment-emergent adverse events (TEAEs) either mild or 
moderate severity in a Phase 1, randomized double-blind, placebo-controlled study designed to 
evaluate the safety, tolerability, and PK of LB-102 in healthy volunteers. The most notable safety 
result was mildly elevated prolactin levels, which was expected to occur based on LB-102’s 
mechanism of action as a dopamine antagonist and that it is a commonly reported AE for drugs 
of this class.1 At the highest dose (200 mg LB-102) minor interval between Q and T wave 
corrected for heart rate using Fridericia’s formula (QTcF) prolongation was noted; however, 
predefined QT stopping criteria were not reached. In addition, a single incidence of acute 
dystonia was observed at 200 mg LB-102 once daily (QD) as well as a single incidence at 75 mg 
twice daily (BID) and 2 at 100 mg LB-102 BID. There were no serious adverse events (SAEs) 
during the course of the study. The Columbia-Suicide Severity Rating Scale (C-SSRS) score did 
not change during study treatment. The maximum tolerated dose (MTD) of LB-102 was 
identified as 150 mg per day. Study LB-102-001 achieved its objectives of identifying the safety, 
tolerability, and PK of a single oral dose and multiple oral doses of LB-102 in healthy 
volunteers.  
LB-102 was rapidly absorbed and LB-102 concentration generally declined from peak in an 
apparent biphasic manner. Exposure increased in a slightly greater than dose-proportional 
manner. Apparent clearance appeared to decrease as dose increased. Minor (as defined by the 
FDA)1 amounts of amisulpride, approximately 2.5% of LB-102, were detected in plasma 
samples. The plasma concentrations of amisulpride at lower doses were within several fold of 
lower limit of quantification (LLOQ) making descriptive PK analysis tenuous. For PK results in 
Part B (multiple ascending doses [MAD]), trough concentrations of LB-102 and amisulpride 
plateaued before the morning dose on Day 4. After multiple doses, there was slight to moderate 
accumulation of LB-102 across dose levels. 
An open-label positron emission tomography (PET) study was conducted to evaluate dopamine 
RO of LB-102 administered orally to healthy volunteers. This was a Phase 1, open-label study 
with 4 cohorts consisting of 4 patients each. Eligible patients received 1 dose of LB-102 on 
Day 1; patients in the final cohort were dosed for 4 days QD on an inpatient basis. Blood 
samples for PK and safety assessments were collected at Screening, immediately pre-dose, and 
during, before, and after the PET scan. Patients enrolled in the inpatient cohort were monitored 
daily. Follow-up after discharge consisted of a phone call the next day to check on patients. This 
was an adaptive study and doses in Cohorts 2 to 4 were determined after PET data from Cohort 1 
were obtained. For Cohort 1 and 2 dynamic, 11C raclopride PET scans were obtained at Baseline, 
2.5, 7.5, and 23.5 hours after LB-102 administration. For Cohort 3 dynamic, 11C raclopride PET 
scans were obtained at Baseline, 2.5, 7.5, 23.5, and 47.5 hours after LB-102 administration. For 

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Cohort 4 dynamic, 11C raclopride PET scans were obtained at Baseline, 2.5, 7.5, and 23.5 hours 
post-fourth day dosing. 
Cohort 
Treatment 
1 (n=4) 
LB-102 50 mg, single dose 
2 (n=4) 
LB-102 100 mg, single dose 
3 (n=4) 
LB-102 75 mg, single dose 
4 (n=4) 
LB-102 100 mg, multiple dose 2 patients ; LB-102 50 mg, multiple dose 2 patients 
Striatal RO, as measured as the average of the caudate and putamen, are presented in Figure 1.1. 
 
Figure 1.1: 
Striatal dopamine RO from single dose cohorts of LB-102-002 
 
Abbreviations: h = hour; RO = receptor occupancy 
Striatal RO for subjects who received multiple QD doses, i.e., steady state (SS) conditions, of 
LB-102, either 50 mg (n = 2) or 100 mg (N = 2) are presented in Figure 1.2. 
 

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Figure 1.2: 
Striatal dopamine RO from single dose cohorts of LB-102-002 
 
Abbreviations: h = hour; RO = receptor occupancy; SS = steady state. 
There were no SAEs in this study. Results of this study showed that LB-102 afforded dopamine 
RO in the desired range to treat schizophrenia, under SS conditions, as doses as low as 
50 mg/day. A correlation between dopamine RO and plasma LB-102 concentration could not be 
established. 
Further information on the Phase 1 trials can be found in the Section 14.2. 
1.5 
Study Rationale 
The current Phase 2 study is part of the LB-102 clinical development program designed to 
demonstrate the efficacy and safety of LB-102 for the treatment of patients with acutely 
exacerbated schizophrenia. A 4-week double-blind Treatment Period is of adequate length to 
determine whether an antipsychotic effect has been demonstrated. Since efficacy in 
schizophrenia is dependent on both treatment duration and dose, a fixed dose approach 
represents the optimal study design to evaluate efficacy. To facilitate enrollment of acutely ill 
patients and optimize treatment compliance, a 4-week inpatient hospitalization is required 
following the initial screening phase. 
1.6 
Dose Rationale 
Based on the mechanism of action of LB-102 at dopamine D2 and 5HT7 receptors, data from 
animal models, and PET dopamine RO data, it is hypothesized that LB-102 will have 
antipsychotic effects at doses ranging from 50 mg/day to 100 mg/day. 

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1.7 
Study Endpoint Rationale 
The scale utilized for the primary study endpoint, Positive and Negative Syndrome Scale 
(PANSS) is validated and widely used in this patient population.  
1.8 
Risks and Benefits for Patients 
1.8.1 
Risks 
Administration of second generation antipsychotics (SGAs) (including the metabolite of LB-102, 
amisulpride) can result in extrapyramidal symptoms, weight gain, elevations in lipids and blood 
sugar, sedation, dry mouth, constipation, dizziness, and falls due to low blood pressure, QTcF 
prolongation, cognitive impairment, and prolactin elevation.1  
Electrocardiograms (ECGs) and clinical laboratory tests will be conducted throughout the study.  
The effect of LB-102 on pregnant women and fetal development is unknown. Therefore, women 
who are pregnant or lactating will be excluded from this study, and highly effective 
contraception will be required of all female participants of childbearing potential and of male 
participants with sexual partners of childbearing potential. Pregnancy tests will also be required 
of female participants of childbearing potential before the start of treatment. 
1.8.2 
Benefits 
In the 2 clinical trials conducted to date, LB-102 was shown to have an overall safety profile that 
was similar to other SGAs. 
Schizophrenia is a chronic and debilitating mental illness that affects approximately 1% of the 
population. Schizophrenia manifests in hallucinations and delusions, dysfunctional thinking, 
social withdrawal and lack of emotion, energy, and motivation. Schizophrenia patients suffer a 
profoundly reduced quality of life and are 10 times more likely to commit suicide than the 
general population.1 Despite a seeming surfeit of available drugs to treat schizophrenia, adequate 
treatment of schizophrenia remains a challenge.1 LB-102 was designed to be an improved 
version of amisulpride and in vitro studies have demonstrated that it has an increased membrane 
permeability, which could potentially decrease the magnitude and frequency of AEs typically 
observed in patients treated with amisulpride.1 LB-102 may offer improved clinical benefit 
relative to the currently available treatments for schizophrenia.  

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2 STUDY OBJECTIVES 
2.1 
Primary Objective 
The primary objective of this study is: 
• To determine whether LB-102 administered to patients with acutely exacerbated 
schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline 
on the PANSS total score, compared to placebo. 
2.2 
Secondary Objectives 
The secondary objectives of this study are:  
• To evaluate the safety and tolerability of LB-102 in patients with acutely exacerbated 
schizophrenia.  
• To assess the effect of LB-102 on the severity of illness in patients with acutely exacerbated 
schizophrenia, as determined by a change from Baseline in the Clinical Global 
Impressions-Severity of Illness scale (CGI-S) score.  
• To assess the effect of LB-102 on PANSS subscale and Marder Factor scores in patients with 
acutely exacerbated schizophrenia. 
2.3 
Exploratory Objectives 
• To explore the effect of LB-102 on Cogstate test score 
 

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3 STUDY ENDPOINTS 
3.1 
Primary Endpoint 
The primary endpoint of this study is: 
• Change from Baseline to Week 4 in the PANSS total score, compared to placebo 
3.2 
Secondary Efficacy Endpoints 
The secondary endpoints of this study are: 
• Change from Baseline to Week 4 in the CGI-S score 
• Change from Baseline to Week 4 in PANSS positive subscale score 
• Change from Baseline to Week 4 in PANSS negative subscale score 
• Change from Baseline to Week 4 in PANSS Marder Factor scores 
• Response rate, defined as 
o Reduction of ≥20% from Baseline in PANSS total score at Week 4 
3.3 
Exploratory Endpoint 
• Effect of LB-102 on Cogstate test score 
3.4 
Safety Endpoints 
Safety will be assessed by the following: 
• AE reporting 
• Physical examination 
• Vital signs 
• Body weight, body mass index (BMI; derived programmatically from body weight and 
height measurements), and waist circumference 
• Clinical laboratory tests (hematology, serum chemistry [including prolactin], urinalysis, and 
pregnancy tests); prothrombin time (PT), activated partial thromboplastin time (aPTT), 
international normalized ratio (INR), glycosylated hemoglobin (HbA1c), cortisol, 
adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH) and total 
cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) 
• 12-lead ECGs 

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• Assessments of EPS: the Simpson-Angus Scale (SAS), the Abnormal Involuntary Movement 
Scale (AIMS), the Barnes Akathisia Rating Scale (BARS) 
• C-SSRS 

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4 STUDY PLAN 
4.1 
Study Design 
This Phase 2 randomized, double-blinded, placebo-controlled, fixed dose, multicenter clinical 
study is designed to evaluate the efficacy, safety, tolerability, and PK of LB-102 50 mg QD, 
LB-102 75 mg QD, and LB-102 100 mg QD versus placebo in patients diagnosed with 
schizophrenia having an acute exacerbation of psychosis.  
An informed consent form (ICF) form must be signed by the patient before any study-related 
procedures are performed. 
Approximately 350 patients will be randomized to receive 1 of 4 study treatments in a 3:3:3:1 
ratio: placebo QD, LB-102 50 mg QD, LB-102 75 mg QD, or LB-102 100 mg QD, for 28 days. 
Re-screening may be permitted on a case-by-case basis with the approval of LB Pharmaceuticals 
and Medical Monitors. The study will be conducted in up to 25 study centers. 
Study participation will last approximately 8 weeks and includes a 7-day inpatient screening 
phase (up to a 7-day extension of the screening phase is allowed, if necessary with the approval 
of the Medical Monitor), an inpatient Study Treatment Period with 4 weeks of daily study 
treatment, an inpatient Stabilization Period of up to 5 days (during which patients will be 
stabilized on standard antipsychotic medication), and an outpatient Final Safety Follow-up of 
approximately 2 weeks after the end of the Treatment Period. 
Patients will be evaluated at Baseline and periodically thereafter using the PANSS, CGI-S, SAS, 
BARS, AIMS, C-SSRS, 12-lead ECG, vital signs, clinical laboratory values, body weight/waist 
circumference, total cholesterol, triglycerides, HDL, and LDL and reported/observed AEs. In 
addition, blood samples will be collected for PK analysis. 
The study is summarized graphically in Figure 4.1.

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Figure 4.1: 
Study Schematic 
 
 
 
a Inpatient 
Abbreviations: D = Day; EoS = end of study; EoT = end of treatment; mg = milligram; QD = once daily 
 

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4.1.1 
Stopping Criteria 
4.1.1.1 
Individual Patient Stopping Criteria 
Dosing of an individual patient will cease if any of the following criteria are met: 
• SAE regardless of association to LB-102 or placebo according to the Principal Investigator 
(PI) and notification to the Medical Monitor. 
• Any other event that is deemed by the Investigator or Sponsor to pose an unacceptable risk to 
the patient. 
4.1.1.2 
QT Prolongation Stopping Criteria 
Dosing of an individual patient will cease if any of the following criteria are met: 
• An increase in QTcF to >500 msec for male and female patients. 
OR 
• An increase in QTcF of >60 msec over Baseline. 
A confirmation of an abnormal finding meeting the stopping criteria will be required within 
15 minutes of the initial QTcF reading. 
4.2 
Study Duration 
The duration of participation for each individual patient in this study will be approximately 
8 weeks, including a 7-day inpatient screening phase (up to a 7-day extension of the screening 
phase is allowed, if necessary with the approval of the Medical Monitor), a 28-day inpatient 
Study Treatment Period and up to 5-day inpatient Stabilization Period, and the Final Safety 
Follow-up approximately 2 weeks after the completion of the Treatment Period. 
Up to 25 sites are planned to randomly assign approximately 350 patients over a 18-month 
period.  
4.3 
Safety Review Committee 
A Safety Review Committee (SRC) will be established to review available safety data; details 
are included in the safety data plan.  
Detailed roles, responsibilities, and administrative conduct of the SRC will be documented in the 
LB-102-003 Safety Review Committee Plan. The plan will define the roles and responsibilities 
of the SRC, its membership, and purpose and timing of its meetings. The plan will also describe 
procedures for communication, documentation, and an outline of data that will be provided to the 
SRC for review. 
 
 

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5 STUDY POPULATION 
Patients must meet all inclusion criteria and have none of the exclusion criteria at Baseline to be 
enrolled in the study. No deviations will be permitted from the inclusion or exclusion criteria. 
The Investigator may contact the Medical Monitor to discuss eligibility of any given patient. 
To ensure the inclusion of appropriate patients, the information collected during the screening 
phase that pertains to the diagnosis of schizophrenia, evaluation of the level of disease severity 
and exacerbation, and the distinction between symptoms of exacerbated schizophrenia and 
comorbid conditions will be recorded (e.g., using an audio recording device). In addition, the 
Mini International Neuropsychiatric Interview version 7.0.2 (MINI 7.0.2), Placebo-Control 
Reminder Script (PCRS) and Structured Clinical Interview for the Positive and Negative 
Syndrome Scale (SCI-PANSS) will be audio recorded. The information and recorded interviews 
will be submitted for review by an experienced independent central reviewer to confirm that the 
patient is appropriate for inclusion in the study. In addition, at Baseline and final endpoint, 
SCI-PANSS will be evaluated by a local rater with central supervision via independent, central 
review. In addition, SCI-PANSS is audio recorded at all applicable visits when they are 
administered; however, the patient withdrawal or refusal of consent for recording will not 
preclude participation in the study. 
Specific entry criteria are detailed in Section 5.1 and Section 5.2.  
5.1 
Inclusion Criteria 
Patients will be eligible for inclusion in the study if they meet all of the following criteria: 
1. Patient, who is able to provide written informed consent (as required by Institutional Review 
Board [IRB]) prior to the initiation of any protocol-required procedures. Ability, in the 
opinion of the PI, to understand the nature of the trial and follow protocol requirements, 
including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited 
concomitant medication, and to be reliably rated on assessment scales. 
2. Must be willing to be hospitalized for the duration of the inpatient period of the study, and 
willing to comply with instructions from the Investigator and study staff. 
3. Have stable living environment when not in hospital, as demonstrated by the ability to 
provide contact information for themselves or family/friend(s)/caregiver(s). 
4. Male and female patients 18 to 55 years of age inclusive at the time of informed consent with 
a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental 
Disorders, Fifth Edition (DSM-5) criteria and confirmed by the MINI 7.0.2 for Schizophrenia 
and Psychotic Disorders Studies. 
5. BMI must be ≥18 and ≤40 kg/m2. 

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6. Patient who is: 
• experiencing an acute exacerbation of psychotic symptoms, with onset ≤6 weeks before 
Screening AND the patient requires hospitalization for this acute exacerbation of 
psychotic symptoms.  
 OR  
• if already an inpatient at Screening, has been hospitalized for onset ≤2 weeks for the 
current exacerbation. 
7. Patients who are experiencing an acute exacerbation of psychotic symptoms and marked 
deterioration of usual function as demonstrated by meeting ALL of the following criteria at 
the Screening and Baseline visits: 
• Total PANSS score between 80 and 120, inclusive, and 
• Score of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items: Item 1 
(P1; delusions), Item 2 (P2; conceptual disorganization), Item 3 (P3; hallucinatory 
behavior), Item 6 (P6; suspiciousness/persecution), and 
• CGI-S score ≥4 (moderately to severely ill). 
8. Have received previous antipsychotic treatment (dose and duration as per the label) and who 
showed a previous good response to such antipsychotic treatment (other than clozapine) in 
the last 12 months, according to the Investigator’s opinion. 
9. Have history of relapse and/or exacerbation of symptoms when they were not receiving 
antipsychotic treatment, according to the Investigator’s opinion. 
10. Patients willing to discontinue all prohibited psychotropic medications prior to Screening, if 
determined to be clinically appropriate by the Investigator, and not for the sole purpose of 
inclusion in the trial.  
5.2 
Exclusion Criteria 
Patient will be excluded from the study if they meet any of the following criteria: 
Sex and Reproductive Status 
1. Sexually active females of childbearing potential and male patients who are not practicing 2 
different methods of birth control with their partner during the trial and for 30 days after the 
last dose of trial medication or who would not remain abstinent during the trial and for 30 
days after the last dose. If employing birth control, each couple must use 2 of the following 
precautions: oral contraceptives, patch contraceptives, injection contraceptives, implantable 
hormonal contraceptives, male condom with intravaginal spermicide, diaphragm or cervical 
cap with spermicide, vaginal contraceptive ring, intrauterine device or system, surgical 
sterilization (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy), tubal 

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ligation/occlusion, vasectomized partner, or sexual abstinence, if this is the patient’s current 
practice. Contraceptive requirements do not apply to patients who are in same sex 
relationship, who are medically or surgically sterilized (e.g., bilateral tubal ligation, bilateral 
oophorectomy, hysterectomy); or practice sexual abstinence during this study. 
2. Females who are breastfeeding or who have a positive pregnancy test result prior to receiving 
trial medication. 
Target Disease 
3. Patients who presented with a first episode of schizophrenia based on the clinical judgment 
of the Investigator and patients with diagnosed schizophrenia equal to or less than a year. 
4. Improvement of ≥20% in total PANSS score between the Screening and Baseline 
assessments. 
5. History of treatment resistance to schizophrenia medications defined as failure to respond to 
2 adequate courses of pharmacotherapy (dose and duration as per the label) or required 
clozapine within the last 12 months. 
6. Current DSM-5 Axis I diagnosis other than schizophrenia including, but not limited to 
schizoaffective disorder, major depressive disorder, bipolar disorder, post-traumatic stress 
disorder, anxiety disorders, delirium, dementia, amnestic or other cognitive disorders as 
determined by the MINI 7.0.2. Also, patients with borderline, paranoid, histrionic, 
schizotypal, schizoid, or antisocial personality disorder, as determined by the MINI 7.0.2 and 
Mini International Neuropsychiatric Interview with Borderline Personality Disorder Module 
version 7.0.2 (MINI-Plus BPD 7.0.2). 
7. Risk for suicidal behavior during the study as determined by the Investigator’s clinical 
assessment and Columbia-Suicide Severity Rating Scale (C-SSRS) as confirmed by the 
following: answers “Yes” on items 4 or 5 (C-SSRS – Ideation) with the most recent episode 
occurring within the 6 months before Screening, or answers “Yes” to any of the 5 items 
(C-SSRS – Suicidal Behavior) with an episode occurring within the 12 months before 
Screening. This assessment will be repeated at Baseline Visit (at baseline “Since Last Visit” 
version of the CSSR-S scale should be used). Non-suicidal self-injurious behavior is not 
exclusionary. 
8. Risk of violent or destructive behavior based on the Investigator’s opinion and homicidal 
ideation based on responses to SCI-PANSS interview questions or statements made by the 
patient at any other times during the Screening or Baseline visits. 
9. Patients with clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 
of the AIMS at Screening. 
10. Patients with a score of ≥3 on the BARS global clinical assessment of akathisia at Screening. 
Medical History and Concurrent Diseases 

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11. Patients who met DSM-5 criteria for substance abuse or dependence within the past 1 year, 
including alcohol and benzodiazepines, but excluding caffeine and nicotine. Previous 
occasional use of alcohol or cannabis is allowed as long as the level of use does not meet 
DSM-5 criteria for any moderate or severe substance use disorder within the 12 months prior 
to Screening, and the use of alcohol or cannabis is not considered to be the precipitating 
factor of the current psychotic episode in the opinion of the Investigator; subjects are 
required to abstain from alcohol and cannabis use during the trial. 
12. Patients with hypothyroidism or hyperthyroidism (unless condition had been stabilized with 
medications for at least the past 90 days) and/or clinically significant abnormal thyroid 
function (abnormal TSH levels followed by free T3 and T4 levels), as assessed by the 
Investigator, in discussion with the study Medical Monitor.  
13. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, 
hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or 
oncologic disease or any other condition that, in the opinion of the Investigator, would 
jeopardize the safety of the subject or the validity of the study results. Positive result at 
Screening for hepatitis B surface antigen (HbsAg), hepatitis C virus, or human 
immunodeficiency virus- (HIV)-1 or -2. Patients with chronic hepatitis B or hepatitis C may 
be included after discussion with the Medical Monitor provided that their condition is stable 
and values for liver function test meet the specified criteria of alanine aminotransferase 
(ALT) and aspartate aminotransferase (AST) <2 × upper limit of normal (ULN). The 
Medical Monitor should be contacted in any instance where the Investigator is uncertain 
regarding the stability of a patient’s medical condition(s) and the potential impact of the 
condition(s) on trial participation. 
14. Patients with insulin-dependent diabetes mellitus (i.e., any patients using insulin) are 
excluded. Patients with non-insulin-dependent diabetes mellitus may be eligible for the trial 
if their condition is stable as determined by satisfying ALL of the following criteria: 
• Glycosylated hemoglobin (HbA1c) <7.0%, and 
• Screening glucose must have been ≤125 mg/dL or ≤6.94 mmol/L (fasting) or 
<200 mg/dL or <11.1 mmol/L (non-fasting). If the non-fasting Screening glucose was 
≥200 mg/dL or ≥11.1 mmol/L, patients must have been retested in a fasted state and the 
retest value must have been ≤125 mg/dL or ≤6.94 mmol/L, and 
• Patient had been maintained on a stable regimen of oral antidiabetic medication(s) for at 
least 28 days prior to Screening or diabetes had been well controlled by diet for at least 
28 days prior to Screening, and 
• Patient had no hospitalizations within the 12 months prior to Screening due to diabetes or 
complications related to diabetes, and 
• Patient’s diabetes should not be newly diagnosed during Screening for the trial. 

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15. Patients with uncontrolled hypertension (diastolic blood pressure [DBP] >95 mmHg in any 
position or systolic blood pressure [SBP] >145 mmHg) or symptomatic hypotension, or 
orthostatic hypotension defined as a decrease of ≥20 mmHg in SBP or a decrease of 
≥10 mmHg in DBP after at least 3 minutes standing compared with the previous supine 
blood pressure, OR development of symptoms. NOTE: Blood pressure measurements may be 
repeated once to ensure reproducibility of the exclusionary result(s) before excluding a 
patient based on the criteria noted above. 
16. Patients with known ischemic heart disease or any history of myocardial infarction, 
congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or 
coronary artery bypass surgery. 
17. Patients with epilepsy or a history of seizures (with the exception of febrile seizure). 
Physical and Laboratory Results 
18. Patients with a positive urine drug screen or a positive blood alcohol test. Detectable levels of 
marijuana, barbiturates, benzodiazepines or opiates in the drug screen are not exclusionary if, 
in the Investigator’s documented opinion, the patient does not meet DSM-5 criteria for 
substance abuse or dependence, in the Investigator’s documented opinion, the positive test 
does not signal a clinical condition that would impact the safety of the patient or 
interpretation of the trial results, and approval was granted by the Medical Monitor prior to 
treatment. 
19. Patients with a history of alcohol use disorder, substance use disorder (by DSM-5 criteria) 
within 12 months of Screening or a positive screen for drugs of abuse at Screening (unless 
consistent with current prescription for medical condition). 
20. The following laboratory test results are exclusionary:  
• Platelets ≤75,000/µL or ≤75×109/L 
• Hemoglobin ≤9 g/dL or ≤90 g/L 
• Neutrophils, absolute ≤1000/µL or ≤1×109/L 
• AST >2 × ULN 
• ALT >2 × ULN 
• Creatine phosphokinase >3 × ULN, unless discussed with and approved by the Medical 
Monitor 
• Creatinine ≥2 mg/dL or ≥176.8 µmol/L 
• Estimated creatinine clearance of <45 mL/min, calculated using the Cockcroft-Gault 
equation, at Screening 

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• HbA1c ≥7.0%  
• Abnormal free T4 (during Screening), unless discussed with and approve by the Medical 
Monitor (Note: Free T4 will be measured only if the result for TSH is abnormal)  
21. Clinically significant abnormal finding on the triplicate set of ECGs or evidence of any of the 
following cardiac conduction abnormalities at Screening (mean values will be used for the 
following criteria): 
• Heart rate <40 beats per minute (bpm) and >110 bpm (based on the ECG reading). 
NOTE: The Medical Monitor should be contacted in any instance where the Investigator 
is uncertain regarding the stability of a patient’s medical condition(s) and the potential 
impact of the condition(s) on trial participation 
• Interval between Q and T wave corrected for heart rate using Fridericia’s formula (QTcF) 
interval >450 msec for males and females 
• PR interval ≥200 msec 
• Intraventricular conduction delay with QRS duration >120 msec 
• Evidence of second- or third-degree atrioventricular block  
• Electrocardiographic evidence of complete left bundle branch block (LBBB), complete 
right bundle branch block (RBBB), or incomplete LBBB 
Prohibited Therapies or Medications 
22. Patients who are currently taking oral antipsychotic medications, monoamine oxidase 
inhibitors (MAOIs), anticonvulsants (e.g., lamotrigine, Depakote), tricyclic antidepressants 
(e.g., imipramine, desipramine), selective serotonin reuptake inhibitors, and any other 
antidepressants or any other psychoactive medications (except lorazepam, zolpidem, 
zaleplon, eszopiclone, or similar benzodiazepines, diphenhydramine, benztropine, and 
propranolol). Patients taking prohibited psychotropic medications may be eligible for 
inclusion in the study if it is clinically appropriate to discontinue the medication before the 
Baseline Visit (in the opinion of the Investigator). The prohibited psychotropic agent must be 
discontinued and washed out at least 5 half-lives prior to Baseline. Subjects taking a depot 
antipsychotic could not have received a dose of medication for at least 1 and a half injection 
cycles before Baseline. The medications should not be discontinued solely to make the 
patient eligible for enrollment in the study. 
23. Patients who received electroconvulsive therapy within 90 days of Screening. 
24. Patients who received Transcranial Magnetic Stimulation (TMS) within 90 days of 
Screening. 

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Allergies and Adverse Drug Reactions 
25. Patients with a history of neuroleptic malignant syndrome. 
26. Patients with a history of allergic response (defined as hypersensitivity reactions such as 
flushing, rash, wheezing, abdominal cramps, hypotension, seizure, etc., not intolerance) to 
more than 1 class of medications. 
Others 
27. Prisoners or patients who are compulsorily detained (involuntarily hospitalized) for treatment 
of either a psychiatric or physical illness or have been in the last 6 months prior to the 
Screening Visit must not be enrolled in this study. 
28. Patients who have participated in another clinical study in which they received an 
experimental or investigational drug agent within 3 months of Screening. 
5.3 
Patient Withdrawal/Discontinuation Criteria 
All patients are free to withdraw from participation in this study at any time for any reason and 
without prejudice. 
A patient will be considered to have completed the study when they complete the End of Study 
(EoS) Visit (Visit 7). If a patient is discontinued at any time after randomization into the study, 
the Investigator will make every effort to follow the patient and complete the follow-up 
procedures at an Early Termination (ET) Visit as follows: 
• Recording of concomitant medications (e.g., prescription and nonprescription medications) 
• Full physical examination  
• Bodyweight, BMI (derived programmatically from body weight and height measurements), 
and waist circumference 
• Vital signs 
• Resting 12-lead ECG (triplicate, further information in Section 8.2.3) 
• Collection of blood and urine samples for clinical laboratory tests. Additional information is 
presented in the footnotes to the schedule of assessments (SoA) (Table ) 
• Urine pregnancy test for all females of childbearing potential 
• Assessment and recording of AEs 
• PANSS, PCRS must be administered before PANSS 
• CGI-S 

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• C-SSRS  
• AIMS 
• BARS 
• SAS 
• Cogstate test 
Patients may be replaced; however, this must be assessed on a case-by-case basis and be 
approved by the Sponsor or their designee.  
The data on ET will be captured in electronic case report form (eCRF) that should be collected 
for every patient who receives study drug, whether or not the patient completes the study. The 
reason for any early discontinuation should be indicated on this form. The primary reason for a 
patient discontinuing early should be selected from the following standard categories: 
• Adverse Event: Clinical or laboratory events occurred that, in the medical judgment of the 
Investigator for the best interest of the patient, are grounds for discontinuation. These events 
include SAEs and nonserious AEs regardless of relation to the study drug. 
• Lack of Efficacy: Worsening of psychotic symptoms. 
• Non-compliance with study drug according to the PI. 
• Protocol Deviation: The patient’s findings or conduct failed to meet the protocol entry 
criteria or failed to adhere to the protocol requirements (e.g., drug non-compliance, failure to 
return for defined number of visits).  
• Withdrawal of Consent: The patient desired to withdraw from further participation in the 
study in the absence of an Investigator-determined medical need to withdraw – if consent is 
withdrawn, the patient must be questioned by the Investigator or site staff whether the 
withdrawal is due to an AE, lack of efficacy, personal or family reasons, or whether the 
patient withdrew consent and refused all EoS procedures including refusing to give a reason; 
these reasons must be documented in the eCRF, consistent with FDA recommendations. If 
the patient gave a reason for withdrawing, it should be recorded in the eCRF. 
• Investigator Decision: In the Investigator’s opinion, continuation in the study would be 
detrimental to the patient’s well-being. 
• Death: The patient died. 
• Lost to Follow-up: The patient stopped coming for visits and study personnel were unable to 
contact the patient. 
• Study Terminated by Sponsor. 

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• Other: The patient was discontinued for a reason other than those listed above, such as theft 
or loss of study drug. The reason must be clearly documented in the eCRF in order to 
determine whether the withdrawal was associated with an AE or lack of efficacy. 
If a patient is withdrawn from dosing before completing the study, the reason for withdrawal will 
be entered in the appropriate eCRF. Whenever possible and reasonable, evaluations scheduled 
for study completion should be performed at the time of premature discontinuation of dosing. All 
patients who withdraw from the study with an ongoing AE must be followed until the event is 
resolved or deemed stable.  

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6 STUDY TREATMENT AND MANAGEMENT 
6.1 
Description 
Information about the study drugs is provided in 1.  
Table 6.1: 
Details of Study Drug 
 
Preparations to Be Administered 
 
LB-102 
Placebo 
Active Agent 
N-methyl amisulpride  
Not applicable 
Manufacturer 
API is made by Procos in Italy 
Tablets are made by Quotient in the UK 
Quotient in UK 
Dose(s) 
50 mg, 75 mg, 100 mg 
Not applicable 
Route 
Oral  
Oral 
Formulation 
Tablet  
Tablet  
Strength(s) 
50 mg 
Not applicable 
Abbreviations: API = Active Pharmaceutical Ingredient; UK = United Kingdom 
6.1.1 
Formulation and Preparation 
 

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6.1.2 
Labeling 
Study drugs will be packaged and labeled by PCI in Illinois in accordance with applicable 
regulatory requirements.  
6.1.3 
Storage 
Study drug must be stored at secure and locked location at temperature ranges between 
20°C – 25°C (68°F – 77°F) with acceptable excursions to 15°C – 30°C (59°F and 86°F) is 
allowed. 
Verbal and written instructions for proper storage, handling, and administration of the study drug 
will be given to the patient and will include instructions to contact the study site immediately if 
they experience problems with the study drug and/or administration. 
Site storage conditions should be monitored by the site personnel and reviewed by the monitor 
during site visits. Deviations from the storage requirements must be documented and reported to 
the Sponsor. 
Complete instructions for proper study drug storage and handling will be provided in the 
Pharmacy Manual. 
6.2 
Shipment, Blinding, and Unblinding 
6.2.1 
Shipment 
All study drugs will be supplied by the Sponsor and shipped to sites by PCI. No study drug will 
be shipped to a site until authorization has been given by the Sponsor or its representative. The 
study drug will be shipped under ambient conditions.  
6.3 
Treatment Assignment 
This is a randomized, double-blind, placebo-controlled study.  
Patients will be randomized in a 3:3:3:1 ratio to either placebo, LB-102 50 mg QD, LB-102 
75 mg QD, or LB-102 100 mg QD. An unblinded biostatistician, contracted with Worldwide 
Clinical Trials (Worldwide), will be responsible for generating and implementing the 
randomization scheme that will determine treatment assignment. Randomization will occur 
through an integrated response technology (IRT) system. The IRT system will generate the 
randomization number and the randomization number will be captured by and integrated into the 
electronic data capture (EDC) system. The patient identification will be a 6-digit number (i.e., 
the 1-digit country number, followed by a 2-digit site number followed by a hyphen and a 3-digit 
consecutive number).  
PK analyses will include the first 60 patients randomized regardless of cohort and PK blood 
samples will be collected on Day 1, 8, and 21 during the following timepoints after the morning 
dose: 15 minutes, 30 minutes, 1, 2, 3, 4, 8, and 24 hours. On Day 1 only, a pre-dose PK blood 
sample will be collected. Refer to Section 8.3 for PK windows. 

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6.3.1 
Blinding and Unblinding Treatment Assignments 
This study will be conducted under double-blind conditions such that neither the patient nor the 
Investigator or study staff members working directly with patients will know the identity of each 
patient’s treatment.  
Each site will assign a dedicated unblinded pharmacist and/or applicable unblinded study team 
member for the preparation of LB-102 or placebo. The knowledge of the patients assigned 
treatment will only be available to assigned unblinded pharmacist/unblinded study staff member. 
The unblinded pharmacist/unblinded staff team member ensures the treatment assignment is not 
shared with any study staff having direct patient contact and that no other unblinding occurs. 
Clinical sites should follow site specific procedures/processes to ensure the blind is maintained.  
Treatment assignment for an individual patient is restricted. In an emergency situation the 
Investigator may unblind the patient via the IRT when knowledge of the treatment assignment is 
urgently needed for the clinical management or welfare of the patient.  
If possible, the Investigator should notify the Medical Monitor and/or Chief Medical Officer 
(CMO) before unblinding, but priority should be given to the treatment of the patient.  
Study drug unblinding is restricted to the designated unblinded pharmacist/unblinded study team 
member and the Worldwide clinical pharmacovigilance team, and is provided electronically from 
the IRT. 
Breaking of the blind, other than as described above, will be considered as a protocol violation. 
Any patient whose study drug treatment is unblinded will be discontinued, and the date, time, 
and reason for the unblinding will be documented. Additionally, the Investigator/designee will 
need to update the patient’s status in the IRT.  
6.4 
Dose and Administration 
Approximately 350 patients will be randomized to receive 1 of 4 study treatments in a 3:3:3:1: 
placebo, LB-102 50 mg QD, LB-102 75 mg QD, or LB-102 100 mg QD for 28 days. LB-102 and 
placebo will be administered as visually matched tablets for the treatment of adult patients with 
an acute exacerbation of psychotic symptoms of schizophrenia. LB-102 tablets are 50 mg in 
strength. The placebo tablets will match the 50 mg tablets in appearance. Tablet-splitting 
procedures are outlined in the Pharmacy Manual. Therefore, the following tablets will be 
administered based on randomization:  
 
Dose  
Number of Active 
Tablets  
Number of Placebo 
Tablets  
Total Number of 
Tablets per Dose 
Placebo 
0 
2.5 
2.5 
50 mg 
1 
1.5 
2.5 
75 mg 
1.5 
1 
2.5 
100 mg 
2 
0.5 
2.5 

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6.5 
Accountability 
The unblinded pharmacist/unblinded study staff member at the investigational site must maintain 
adequate records showing the receipt, dispensing, return, or other disposition of study drug, 
including the date, quantity, batch or code number, and identification of patients (patient number 
and initials) who received the study drug. The assigned unblinded pharmacist/unblinded staff 
member ensures the treatment assignment is not shared with any study staff having direct patient 
contact and that no other unblinding occurs. Unblinding treatment assignment documentation 
must be stored in a secured manner that restricts access to the blinded team members.   
The unblinded pharmacist/unblinded study staff member will not supply the study drug to any 
person except those named as Investigators and Sub-Investigators on the FDA 1572, designated 
staff, and patients in this study. The unblinded pharmacist/unblinded study staff member will not 
dispense study drug from any sites other than those listed on the FDA 1572. 
The Investigator must keep an accurate accounting of the number of study drug units delivered to 
the site, dispensed to patients, returned to the Investigator by the patient, and returned to the 
Sponsor or other disposition during and at the completion of the study. The study drug must be 
dispensed to patients only by an appropriately qualified person. The study drug is to be used in 
accordance with the protocol by patients who are under the direct supervision of the Investigator. 
Investigators should maintain records that document adequately that the patients were provided 
the doses specified by the protocol and reconcile all study drug received at the site before final 
disposition.  
Upon completion of the study, unused supplies of study drug will be reconciled. The used and 
unused drug supply will be destroyed on-site, as per the site procedure, with approval of the 
Sponsor or, if not allowed, returned to the Sponsor or designee. 
6.6 
Treatment Compliance 
Administration of study drug will be supervised by study personnel to ensure compliance. 
6.7 
Prior and Concomitant Medications 
All prescription, nonprescription medications (e.g., over-the-counter [OTC]) drugs and herbal 
supplements) and non-medical treatments starting from 30 calendar days before Screening until 
end of the study must be recorded in source documents and the eCRF. For each medication, 
documentation should list the trade or generic name, the total daily dose including units (or the 
dose, units, and scheduled and actual frequency of administration if the medication is not taken 
daily), the route of administration, and the reason for use.  
Changes, additions, or discontinuations to medications will be assessed and recorded in the 
eCRF during each study visit. All as-needed prescriptions should be converted to reflect actual 
dose taken per day. 
Starting on the first day of the screening phase, after written informed consent for the study has 
been provided, all antipsychotic or other psychotropic medications will be stopped with 
clinically appropriate titration down as per the Investigator’s clinical judgment. Patients will be 

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instructed not to take any medication(s) during the conduct of the study unless approved by the 
Investigator. Any patient unable to be safely discontinued from current antipsychotic therapy or 
other psychotropic medications will not be eligible for the study. Any treatment other than the 
study treatment given will be considered a concomitant medication and will be documented in 
the eCRF. Any patient requiring emergency treatment with prescription or nonprescription 
medication during the screening phase through the EoS Visit will be approved by the 
Investigator. If the Investigator determines that the patient requires medication during the study, 
the Medical Monitor must be contacted within 24 hours. 
Psychotropic medications are prohibited except for lorazepam as needed for agitation, 
restlessness, irritability, or hostility; zolpidem, zaleplon, or eszopiclone for insomnia; 
diphenhydramine or benztropine for EPS; and propranolol for akathisia. 
Within the daily limits shown in 2, lorazepam, benztropine, and propranolol are not allowed on 
as needed basis; every administration must be considered and approved by the Investigator prior 
to administration.  
The AE associated with the need for lorazepam, benztropine, or propranolol should be recorded 
on the Adverse Events in the eCRF. The amount and timing for each lorazepam, benztropine, or 
propranolol administration should be recorded for each patient. 
Table 6.2: 
Permitted concomitant medications 
Medication 
Study Period 
Dose Permitted 
Timing Restriction 
Lorazepam 
Screening phase through Day 7 
Maximum of 6 mg/day 
Not within 12 hours prior to 
PANSS 
Day 8 though Day 14 
Maximum of 4 mg/day 
Day 15 through Day 28 
Maximum of 2 mg/day 
On no more than 
4 days/Week 
Benztropine 
Screening phase Through Day 
28 
Maximum 4 mg/day 
Not within 12 hours prior to 
SAS, BARS, or AIMS 
Propranolol 
Screening phase Through Day 
28 
Maximum of 40 mg/day 
Sleep 
Medication 
zolpidem, 
zaleplon, or 
eszopiclone for 
insomnia 
Day 1 and Day 28 
No restrictions a 
Not within 8 hours prior to 
Cogstate test 
a Allow nighttime use only (prn); exclude regular use; exclude daytime use; exclude use within 12 hours of a study visit 
Abbreviations: AIMS = Abnormal Involuntary Movement Scale; BARS = Barnes Akathisia Rating Scale; mg = milligram; 
PANSS = Positive and Negative Syndrome Scale; SAS = Simpson-Angus Scale 
During the End of Stabilization period, the use of lorazepam, benztropine, and propranolol is not 
restricted. 
Smoking is allowed, under supervision. 

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Table 6.3 below provides a select list of CYP2D6 inhibitors and CYP3A4 inhibitors and inducers 
that are prohibited within 14 days of randomization and for the duration of the trial. 
Table 6.3: 
Selected CYP2D6 Inhibitors and CYP3A4 Inhibitors and Inducers 
Prohibited During the Trial 
Selected CYP2D6 Inhibitors 
Celecoxib  
Methadone 
Chloroquine  
Moclobemide 
Chlorpheniramine 
Paroxetine 
Clemastine 
Pyrilamine 
Clomipramine 
Quinidine 
Fluoxetine 
Terbinafine 
Halofantrine 
Tripelennamine 
Hydroxyzine 
 
Selected CYP3A4 Inhibitors 
Amiodarone 
Fluvoxamine 
Amprenavir 
Indinavir 
Aprepitant 
Itraconazole 
Chloramphenicol 
Ketoconazole 
Cimetidine 
Nefazodone 
Clarithromycin 
Nelfinavir 
Clotrimazole (if used orally) 
Quinupristin/Dalfopristin 
Delavirdine 
Ritonavir 
Diltiazem 
Saquinavir 
Erythromycin 
Troleandomycin 
Fluconazole 
Verapamil 
Selected CYP3A4 Inducers 
Carbamazepine 
Phenytoin 
Dexamethasone 
Primidone 
Efavirenz 
Rifampin 
Nevirapine 
St. John’s Wort 
Oxcarbazepine 
Troglitazone 
Phenobarbital 
 
Abbreviations: CYP = cytochrome P450 

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6.7.1 
Acceptable Contraceptive Methods 
For females of childbearing potential who may participate in the study, the following methods of 
contraception, if used properly and used for the duration of the study and for 30 days after the 
last dose of study medication, are generally considered reliable; however, if employing birth 
control, each couple must use 2 of the following precautions: oral contraceptives, patch 
contraceptives, injection contraceptives, implantable hormonal contraceptives, male condom 
with intravaginal spermicide, diaphragm or cervical cap with spermicide, vaginal contraceptive 
ring, intrauterine device or system, surgical sterilization (hysterectomy, bilateral oophorectomy, 
and/or bilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexual 
abstinence, if this is the patient’s current practice. Contraceptive requirements do not apply to 
patients who are in same sex relationship, who are medically or surgically sterilized (e.g., 
bilateral tubal ligation, bilateral oophorectomy, hysterectomy); or practice sexual abstinence 
during this study. 
These methods of contraception also apply to female partners of male patients. 
The Investigator and each patient will determine the appropriate method of contraception for the 
patient during participation in the study. This will be documented at the Screening Visit in the 
patient’s source documentation/medical record. 
Male patients or male partners of female patients should not donate sperm until 90 calendar days 
after the last dose of study drug.  
 

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7 STUDY CONDUCT 
Unless otherwise indicated, all assessments will be performed by the Investigator or designated 
study personnel. 
After signing the ICF, each patient will be screened to ensure eligibility for the study. 
7.1 
Schedule of Assessments 
The study consists of a 7-day inpatients screening phase (up to a 7-day extension of the screening 
phase is allowed, if necessary with the approval of the Medical Monitor), Study Treatment 
Period (Days 1 to Day 28 including Baseline [Day 1]), Stabilization Period (up to 5 days, Days 
29 to 33), and EoS Visit (Visit 7 [Day 42] ± 2 days). Therefore, the maximal study duration for 
an individual patient will be approximately up to 8 weeks.  
Note, this is an inpatient study from Screening to the end of the Stabilization Period. The 
procedures to be performed throughout the study are outlined in the SoA (Table ). 
 

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Table do: 
Schedule of Assessments 
Event 
Screening 
Phase 
Baseline 
Study Treatment Period 
End of 
Stabilization 
Period 
End of 
Study Visit 
Up to 7 
daysa 
Day 
1 
Days 
2-7 
Day 
8 
± 1 
Days 
9-14 
Day 
15 
± 1 
Days 
16-20 
Day 
21 
± 1 
Days 
22-27 
Day 
28 or 
ET 
33c 
Day 42± 2 
Visit Number 
1 
2 
NAb 
3 
NAb 
4 
NAb 
5 
NAb 
6 
7 
8 
Entrance/Screening 
Criteria 
 
 
 
 
 
 
 
 
 
 
 
 
Informed Consenta 
X 
 
 
 
 
 
 
 
 
 
 
 
Admission to Inpatient 
Unita 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
Reviewa 
X 
X 
 
 
 
 
 
 
 
 
 
 
Screening Adjudication 
Form(s) and Recordingsd 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical Historye 
X 
 
 
 
 
 
 
 
 
 
 
 
MINI-Plus BPD 7.0.2 
X 
 
 
 
 
 
 
 
 
 
 
 
Prior Medication Washoutf 
X 
 
 
 
 
 
 
 
 
 
 
 
Hepatitis/HIV 
X 
 
 
 
 
 
 
 
 
 
 
 
Urine Drug and Blood 
Alcohol Screeng 
Xg 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
Efficacy 
 
 
 
 
 
 
 
 
 
 
 
 
(PCRS) SCI-PANSS and 
CGI-S 
Xh 
Xh 
 
X 
 
X 
 
X 
 
Xh 
 
 
Cogstate Test 
Xi 
Xi 
 
 
 
 
 
 
 
Xi 
 
 
Safety 
 
 
 
 
 
 
 
 
 
 
 
 
Prior and Concomitant 
Medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical Examj 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
AIMS 
X 
Xk 
 
Xk 
 
Xk 
 
Xk 
 
Xk 
 
 
SAS 
X 
Xk 
 
Xk 
 
Xk 
 
Xk 
 
Xk 
 
 
BARS 
X 
Xk 
 
Xk 
 
Xk 
 
Xk 
 
Xk 
 
 
C-SSRS 
Xl 
Xm 
 
Xm 
 
Xm 
 
Xm 
 
Xm 
Xm  
Xm  
BMI and Waist 
Circumferencen 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
 

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Event 
Screening 
Phase 
Baseline 
Study Treatment Period 
End of 
Stabilization 
Period 
End of 
Study Visit 
Up to 7 
daysa 
Day 
1 
Days 
2-7 
Day 
8 
± 1 
Days 
9-14 
Day 
15 
± 1 
Days 
16-20 
Day 
21 
± 1 
Days 
22-27 
Day 
28 or 
ET 
33c 
Day 42± 2 
Visit Number 
1 
2 
NAb 
3 
NAb 
4 
NAb 
5 
NAb 
6 
7 
8 
Urine Pregnancy Testo 
X 
X 
 
 
 
 
 
 
 
X 
X 
 
Clinical Laboratories (for 
Screening and exclusionary 
purposes)p 
X 
 
 
 
 
 
 
 
 
 
 
 
Hematology, Serum 
Chemistry including 
Prolactin, Urinalysisq 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
 
TSHr 
X 
 
 
 
 
 
 
 
 
X 
 
 
PT, aPTT, and INR 
X 
X 
 
 
 
 
 
 
 
X 
 
 
ACTH and Cortisol 
 
X 
 
 
 
 
 
 
 
X 
 
 
Resting 12-lead ECGs 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
 
Vital Signst 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
 
Adverse Eventsu 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Other 
 
 
 
 
 
 
 
 
 
 
 
 
Study Drug Dosing 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
PK Sample Collectionv 
 
X 
 
X 
 
 
 
X 
 
 
 
 
Restart Standard 
Antipsychoticw 
 
 
 
 
 
 
 
 
 
 
X 
 
a. 
Screening begins when the ICF is signed and will take place between Day −7 and Day −1; up to a 7-day extension of the screening phase is allowed, if necessary with the 
approval of the Medical Monitor; screening procedures should be initiated with a sufficient amount of time allotted in order to obtain central laboratory results and ECG 
results from the central reader prior to randomization. Review of inclusion/exclusion criteria at Baseline will be based on assessments performed during Screening. 
Hospitalization will begin with the signing of the ICF for patients who are not already hospitalized at the initial Screening Visit. 
b. 
Each patient may receive the QD administration of study treatment. No other assessments are scheduled; however, AEs observed or reported, and concomitant medications 
may be recorded. In case of an AE, an unscheduled visit may be conducted at the discretion of the PI. 
c. 
Stabilization Period is up to 5 days. 
d. 
The Screening assessments to be audio recorded include the MINI 7.0.2, PCRS and SCI-PANSS and are submitted to an independent central reviewer for review and 
eligibility confirmation.  
e. 
Includes full psychiatric history, DSM-5 diagnosis of schizophrenia, and MINI 7.0.2. 
f. 
Washout of prohibited medications begins after signing the ICF and after diagnosis of Schizophrenia is confirmed by MINI. Details of medications requiring washout and 
guidance for washout time required are provided in Appendix 14.4. Prohibited and restricted medications are listed in Table 6.3: . 
g. 
Urine drug screen (full panel including opioids) and a blood alcohol test are required at the designated times, but either or both can be conducted at any time during the trial at 
the discretion of the Investigator. 
h. 
At Screening, Baseline, and final endpoint, SCI-PANSS and CGI-S will be evaluated by a local site rater with central supervision via independent, central review. 
SCI-PANSS will be audio recorded at any visit where they are administered. SCI-PANSS assessment should be preceded by the PCRS. Patients with improvement of ≥20% 

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in total PANSS score between the Screening and Baseline assessments will be excluded from study participation. SCI-PANSS will be administered first on visits before any 
other scales, when SCI-PANSS and CGI-S are being administered with the exception of Screening where MINI-Plus BPD 7.0.2 will be administered first. 
The Placebo-Control Reminder Script© Hassman and Cohen, 2019, Version 5.0 educates clinical trial subjects of key causes of the placebo and nocebo effects, level setting of 
the subject’s study expectations, reminding subjects what a placebo is and how that relates to their reporting of symptoms and potential side effects, and explaining how 
interactions with research site staff differ from their experience with clinical providers. The PCRS informs subjects that they are to be honest about their symptoms and that 
the site staff have no expectations of symptom improvement or worsening and will not be disappointed by the subject’s responses, and asks subjects to explain in their own 
words PCRS content to ensure comprehension. The PANSS Rater will read the PCRS before administering the PANSS at each study visit. 
i. 
During Screening, patients will undergo a practice assessment of the Cogstate test. On Day 1 and Day 28, the actual Cogstate testing will be performed. Note: Cogstate 
Battery test creot be done within 8 hours of receiving a benzodiazepine or sleep medication. 
j. 
To include height at the Screening Visit only. A full physical examination will be conducted at the Screening Visit and at EoT Visit. At each other study visit, patients will be 
assessed for continued dosing and any possible physical symptoms and a targeted physical examination may be performed, if indicated.  
k. 
On Days 1, 8, 15, 21, and 28, the SAS, BARS, and AIMS assessments are to be conducted 3 to 6 hours after the administration of study treatment with the exception of ET 
Visit. 
l. 
If the administration of C-SSRS at Screening highlights the risk of suicide not previously known, in the opinion of the Investigator, the patient should be excluded from the 
trial. At this visit the “Baseline/Screening” version of the C-SSRS scale will be used. 
m. 
At all other study visits the “Since Last Visit” version of the C-SSRS scale should be used. 
n. 
BMI; derived programmatically from body weight and height measurements. 
o. 
All positive urine pregnancy test results must be confirmed by a serum test. Patients with positive urine and serum pregnancy test results at Screening must not be enrolled. 
Patients with positive urine and serum pregnancy test results during the trial must discontinue treatment and be withdrawn from the trial. Pregnancy tests can be performed at 
any point during the trial if pregnancy is suspected. 
p. 
Clinical laboratory samples at Screening for exclusionary purposes are to be taken after a fast of at least 8 hours. Vital signs and ECG should be completed before any blood 
samples are collected. Clinical laboratory test results drawn within ± 24 hours of the scheduled timepoint may be used. Clinical laboratory tests will include the following (see 
Table 14.2: 
 and Section 8.2.4): 
• 
Hematology Screening assessments (excluded test result) will include measurement of hemoglobin (≤9 g/dL or ≤90 g/L), platelets (≤75,000/µL or ≤75×109/L), 
neutrophils (absolute ≤1000/µL or ≤1×109/L). 
• 
Clinical chemistry tests for exclusionary purposes are for ALT (>2 × ULN), AST (>2 × ULN), creatinine (≥2 mg/dL or ≥176.8 µmol/L), CPK (≥3 × ULN, unless 
discussed with the Medical Monitor), HbA1c (≥7.0%), TSH. Important note: Free T4 will be measured only if the result for TSH is abnormal. 
• 
Creatinine clearance will be calculated at Screening using the Cockcroft-Gault equation; estimated creatinine clearance of <45 mL/min is exclusionary.  
q. 
Clinical laboratory samples are to be taken after a fast of at least 8 hours. Vital signs and ECG should be completed before any blood samples are collected. Clinical 
laboratory test results drawn within ± 24 hours of the scheduled timepoint may be used. Routine clinical laboratory tests to be monitored throughout the study will include the 
following:  
• 
Hematology will include measurement of hematocrit, RBC, reticulocytes, and WBC with differential. 
• 
Clinical chemistry will include measurement of albumin, ALT, ALP, amylase, AST, bicarbonate, bilirubin-total, blood urea nitrogen, calcium, creatine kinase, creatinine, 
gamma-glutamyl transpeptidase, globulin, glucose, lactate dehydrogenase, lipase, magnesium, phosphate, potassium, prolactin, sodium, total protein, total cholesterol, 
triglycerides, HDL, LDL and uric acid.  
• 
Urinalysis: pH of freshly voided specimen, specific gravity, protein, glucose, ketones, blood, and microscopic examination of the sediment. 
r. 
Important note: Free T4 will be measured only if the result for TSH is abnormal. 
s. 
Standard 12-lead ECGs (in triplicate) will be performed after the patient has been supine and at rest for ≥5 minutes. The captured ECGs must be separated by at least 
1 minute. A central ECG service will be utilized to review all ECGs in order to standardize interpretations for the safety analysis. In addition, ECG results will be evaluated at 
the investigational site to monitor safety during the trial. Any Screening ECG with abnormal result(s) considered to be clinically significant should be repeated to confirm the 
finding(s) before excluding the patient from the trial. Patients will be randomized based on Screening ECG results from the central reader and Baseline ECG results from the 
trial site. If the Baseline ECG results from the central reader, when available, indicate a QTcF >450 msec at Baseline, the Investigator must contact the Medical Monitor to 
discuss the patient’s continued participation in the trial. ECGs scheduled for the same visit as blood samples are to be completed before blood is drawn. 
t. 
Vital signs will include body temperature, SBP, DBP, and heart rate. Blood pressure and heart rate will be measured in the following order: supine, sitting and standing after 
the patient has been in each position for at least 3 minutes. Vital signs scheduled for the same visit as blood sample have to be completed before blood is drawn.  

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u. 
The recording of AEs is to start immediately after the ICF is signed and up to 14 days after the end of EoT. 
v. 
PK analyses will include the first 60 randomized patients regardless of cohort. PK blood samples will be collected on Day 1, 8, and 21 during the following timepoints after 
the morning dose: 15 minutes, 30 minutes, 1, 2, 3, 4, 8, and 24 hours. See protocol Section 8.3. On Day 1 only, a pre-dose PK blood sample will be collected. Samples are 
collected after ECGs and vital signs. The total volume of blood to be collected during the Screening, treatment, and End of Stabilization period is 161 mL. Approximately 
21 mL of blood will be collected during the Screening Visit, 130 mL will be collected during the 28-day Treatment Period, and 10 mL will be collected during the End of 
Stabilization period.  
w. 
On Day 29 patients are to be started on standard antipsychotic medication as prescribed by the Investigator. 
 
Abbreviations: ACTH = adrenocorticotropic hormone; AE = adverse event; AIMS = Abnormal Involuntary Movement Scale; ALP = alkaline phosphatase; ALT = alanine 
aminotransferase; aPTT = activated partial thromboplastin time; AST = aspartate aminotransferase; BARS = Barnes Akathisia Rating Scale; BMI = body mass index; 
CGI-S = Clinical Global Impressions-Severity of Illness scale; CPK = creatine phosphokinase; C-SSRS = Columbia-Suicide Severity Rating Scale; DBP = diastolic blood 
pressure; DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; ECG = electrocardiogram; EoT = end of treatment; ET = early termination; 
HDL = high-density lipoprotein, HIV = human immunodeficiency virus; ICF = informed consent form; INR = international normalized ratio; LDL = low-density lipoprotein; 
MINI 7.0.2 = Mini International Neuropsychiatric Interview version 7.0.2; MINI-Plus BPD 7.0.2 = Mini International Neuropsychiatric Interview with Borderline Personality 
Disorder Module version 7.0.2; NA = not applicable; PANSS = Positive and Negative Syndrome Scale; PCRS = Placebo-Control Reminder Script; PK = pharmacokinetic; 
PT = prothrombin time; QD = once daily; QTcF = interval between Q and T wave corrected for heart rate using Fridericia’s formula; RBC = red blood cells; 
SAS = Simpson-Angus Scale; SBP = systolic blood pressure; SCI-PANSS= Structured Clinical Interview for the Positive and Negative Syndrome Scale; 
TSH = thyroid-stimulating hormone; ULN = upper limit of normal; WBC = white blood cells. 
 

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7.2 
Study Procedures by Time Point 
7.2.1 
Visit 1 (Screening – up to 7 Days) 
The Screening Visit is to occur within 7 calendar days prior to the start of study drug 
administration. After the patient has signed the ICF, the following assessments will be performed 
and recorded in the patient’s source documentation/medical record and in the eCRF: 
• Administration of informed consent 
• Subjects will also be asked to provide additional consent for their participation in a secure, 
proprietary research subject database administered by Verified Clinical Trials ([VCT], 
Garden City, NY). The database will utilize partially identified subject information to review 
subjects’ research study history within the database. Participants who are identified as 
verification failures by VCT, should not be enrolled without documented approval from LB 
Pharmaceuticals and Worldwide. At the last subject contact, VCT staff will automatically 
close out the subject (safety follow-up, ET, or complete) based on the Interactive Response 
System (IXRS) 
• Admission to inpatient unit 
• DSM-5 diagnosis of schizophrenia 
• MINI 7.0.2  
• MINI-Plus BPD 7.0.2 
• Review of inclusion and exclusion criteria  
• Recording of medical history  
• Recording of prior and current medications (e.g., prescription and nonprescription 
medications) 
• Washout of prohibited psychotropic medications (after signing of ICF) 
• PANSS, PCRS must be administered before PANSS 
• CGI-S 
• C-SSRS 
• Collection of demographic information 
• Physical examination including height 
• Body weight, BMI (derived programmatically from body weight and height measurements), 
and waist circumference 
• Vital signs 
• Resting 12-lead ECG (triplicate, further information in Section 8.2.3) 

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• Collection of blood and urine samples for clinical laboratory tests. Lab results that are 
exclusionary are presented in Table 14.2 and other information is presented in the footnotes 
to the SoA (Table ) 
• Urine pregnancy test for all females of childbearing potential 
• Assessment and recording of AEs 
• Urine drug screen/blood alcohol test  
• AIMS 
• BARS 
• SAS 
• Submission of applicable data to the Endpoint Adjudication Committee for confirmation of 
eligibility 
• Cogstate test - practice assessment 
7.2.2 
Visit 2 (Baseline, Study Day 1) 
At this visit, the following assessments will be performed and recorded in the patient’s source 
documentation/medical record and in the eCRF: 
• Review of inclusion and exclusion criteria 
• Recording of concomitant medications (e.g., prescription and nonprescription medications) 
• Targeted physical examination (if applicable) 
• Body weight, BMI (derived programmatically from body weight and height measurements), 
and waist circumference 
• Vital signs 
• Resting 12-lead ECG (triplicate, further information in Section 8.2.3) 
• Collection of blood and urine samples for clinical laboratory tests. Additional information is 
presented in the footnotes to the SoA (Table ) 
• Urine pregnancy test for all females of childbearing potential 
• Assessment and recording of AEs 
• PANSS- patients with improvement of ≥20% in total PANSS score between the Screening 
and Baseline assessments will be excluded from study participation. PCRS must be 
administered before PANSS  
• CGI-S 
• C-SSRS 
• Randomization 
• Pre-dose PK blood sample will be collected 
• Study drug administration 

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• PK sample collection for the first 60 patients randomized regardless of cohort at the 
following timepoints after the morning dose: 15 minutes, 30 minutes, 1, 2, 3, 4, 8, and 24 
hours 
• AIMS, 3 to 6 hours post-dose 
• BARS, 3 to 6 hours post-dose 
• SAS, 3 to 6 hours post-dose 
• Cogstate test 
7.2.3 
Study Days 2 Through 7 
On Days 2, 3, 4, 5, 6, and 7 each patient may receive the QD administration of study treatment. 
No other assessments are scheduled; however, AEs observed or reported, and concomitant 
medications may be recorded. If any assessments are required in order to evaluate an AE, an 
unscheduled visit may be conducted, at the discretion of the PI. 
7.2.4 
 
Visit 3 (Study Day 8) 
The following Study Day 8 assessments can be performed on Day 8 ± 1 day; however, they 
should all be performed on the same day: 
• Recording of concomitant medications (e.g., prescription and nonprescription medications) 
• Targeted physical examination (if applicable) 
• Body weight, BMI (derived programmatically from body weight and height measurements), 
and waist circumference 
• Vital signs 
• Resting 12-lead ECG (triplicate, further information in Section 8.2.3) 
• Collection of blood and urine samples for clinical laboratory tests. Additional information is 
presented in the footnotes to the SoA (Table )  
• Study drug administration 
• PK sample collection first 60 patients randomized regardless of cohort at the following 
timepoints after the morning dose: 15 minutes, 30 minutes, 1, 2, 3, 4, 8, and 24 hours 
• Assessment and recording of AEs 
• PANSS, PCRS must be administered before PANSS 
• CGI-S 
• C-SSRS 
• AIMS, 3 to 6 hours post-dose 
• BARS, 3 to 6 hours post-dose 

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• SAS, 3 to 6 hours post-dose 
7.2.5 
Study Days 9 Through 14 
On Days 9, 10, 11, 12, 13, and 14 each patient may receive the QD administration of study 
treatment. No other assessments are scheduled. However, any AEs observed or reported, and 
concomitant medications may be recorded. If any assessments are required in order to evaluate 
an AE, an unscheduled visit may be conducted, at the discretion of the PI. 
7.2.6 
Visit 4 (Study Day 15) 
The following Study Day 15 assessments can be performed on Day 15 ± 1 day; however, they 
should all be performed on the same day: 
• Recording of concomitant medications (e.g., prescription and nonprescription medications) 
• Targeted physical examination (if applicable) 
• Bodyweight, BMI (derived programmatically from body weight and height measurements), 
and waist circumference 
• Vital signs 
• Resting 12-lead ECG (triplicate, further information in Section 8.2.3) 
• Collection of blood and urine samples for clinical laboratory tests. Additional information is 
presented in the footnotes to the SoA (Table ) 
• Study drug administration 
• Assessment and recording of AEs 
• PANSS, PCRS must be administered before PANSS 
• CGI-S 
• C-SSRS 
• AIMS, 3 to 6 hours post-dose 
• BARS, 3 to 6 hours post-dose 
• SAS, 3 to 6 hours post-dose 
7.2.7 
Study Days 16 Through 20  
On Days 16, 17, 18, 19, 20, each patient may receive QD administration of study treatment. No 
other assessments are scheduled. However, any AEs observed or reported, and concomitant 
medications may be recorded. If any assessments are required in order to evaluate an AE, an 
unscheduled visit may be conducted, at the discretion of the PI. 

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7.2.8 
Visit 5 (Study Day 21) 
The following Study Day 21 assessments can be performed on Day 21 ± 1 day; however, they 
should all be performed on the same day: 
• Recording of concomitant medications (e.g., prescription and nonprescription medications) 
• Targeted physical examination (if applicable) 
• Bodyweight, BMI (derived programmatically from body weight and height measurements), 
and waist circumference 
• Vital signs 
• Resting12-lead ECG (triplicate, further information in Section 8.2.3) 
• Collection of blood and urine samples for clinical laboratory tests. Additional information is 
presented in the footnotes to the SoA (Table )  
• Study drug administration 
• PK sample collection first 60 patients randomized regardless of cohort at the following 
timepoints after the morning dose: 15 minutes, 30 minutes, 1, 2, 3, 4, 8, and 24 hours 
• Assessment and recording of AEs 
• PANSS, PCRS must be administered before PANSS 
• CGI-S 
• C-SSRS 
• AIMS, 3 to 6 hours post-dose 
• BARS, 3 to 6 hours post-dose 
• SAS, 3 to 6 hours post-dose 
7.2.9 
Study Days 22 Through 27 
On Days 22, 23, 24, 25, 26, and 27 each patient may receive the QD administration of study 
treatment. No other assessments are scheduled. However, any AEs observed or reported, and all 
concomitant medications may be recorded. If any assessments are required in order to evaluate 
an AE, an unscheduled visit may be conducted, at the discretion of the PI. 
7.2.10 
Visit 6 (Study Day 28) 
On Study Day 28, all assessments should be performed on the same day; the last day of study 
drug dosing is Day 28 and, if possible, when any patient discontinues prior to this visit, the 
following assessments will be performed: 
• Recording of concomitant medications (e.g., prescription and nonprescription medications) 

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• Full physical examination (if applicable) 
• Bodyweight, BMI (derived programmatically from body weight and height measurements), 
and waist circumference 
• Vital signs 
• Resting 12-lead ECG (triplicate, further information in Section 8.2.3) 
• Collection of blood and urine samples for clinical laboratory tests. Additional information is 
presented in the footnotes to the SoA (Table ) 
• Study drug administration 
• Urine pregnancy test for all females of childbearing potential 
• Assessment and recording of AEs 
• PANSS. PCRS must be administered before PANSS 
• CGI-S 
• C-SSRS  
• AIMS, 3 to 6 hours post-dose 
• BARS, 3 to 6 hours post-dose 
• SAS, 3 to 6 hours post-dose 
• Cogstate test 
7.2.11 
Stabilization Period (Study Days 29 Through 33) 
Patients are to remain inpatient and be restabilized on standard-of-care antipsychotics, which 
may be started on Day 29. No other assessments are scheduled, and therefore no formal visits are 
shown in the SoA. However, any AEs observed or reported and concomitant medications may be 
recorded. If any assessments are required in order to evaluate an AE, an unscheduled visit may 
be conducted at the discretion of the PI. 
7.2.12 
Visit 7 (Study Day 33) 
On Study Day 33 (or the last day of stabilization if it occurs before Day 33) the following 
assessments will be conducted: 
• Recording of concomitant medications (e.g., prescription and nonprescription medications) 
• Urine pregnancy test for all females of childbearing potential (Table ) 
• Assessment and recording of AEs 
• C-SSRS  

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Based on known PK properties of LB-102, it is expected that within 5 days of the end of the 
Study Treatment Period, plasma concentration of LB-102 and its metabolites is expected to be 
minimal.  
7.2.13 
Visit 8 (End of Study) 
At Visit 8 ± 2 days, the following procedures will be conducted: 
• C-SSRS  
• Recording of concomitant medications (e.g., prescription and nonprescription medications) 
• Targeted physical examination (if applicable) 
• Assessment and recording of AEs 
7.2.14 
Study Procedures for Early Termination and Withdrawal 
If a patient is discontinued at any time after randomization into the study, the Investigator will 
make every effort to follow the patient and complete the follow-up procedures at an ET Visit as 
follows: 
• Recording of concomitant medications (e.g., prescription and nonprescription medications) 
• Full physical examination  
• Bodyweight, BMI (derived programmatically from body weight and height measurements), 
and waist circumference 
• Vital signs 
• Resting 12-lead ECG (triplicate, further information in Section 8.2.3) 
• Collection of blood and urine samples for clinical laboratory tests. Additional information is 
presented in the footnotes to the SoA (Table 7.1) 
• Urine pregnancy test for all females of childbearing potential 
• Assessment and recording of AEs 
• PANSS 
• CGI-S 
• C-SSRS  
• AIMS 
• BARS 

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• SAS 
• Cogstate test

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8 DESCRIPTION OF ASSESSMENTS 
All assessments will be performed throughout the study as noted in the SoA (Table ). 
8.1 
Efficacy Assessments 
8.1.1 
Screening Assessments 
8.1.1.1 
Mini International Neuropsychiatric Interview Version 7.0.2 and Mini 
International Neuropsychiatric Interview With Borderline Personality Disorder Module Version 
7.0.2.  
The MINI 7.0.2 is a brief structured interview for the major Axis I psychiatric disorders in the 
DSM-5 and the International Statistical Classification of Diseases and Related Health Problems, 
Version 10. Seventeen diagnostic modules consisting of screening and a series of secondary 
questions are to be answered with “yes” or “no” responses. If the patient answers “yes” to a 
screening question, the interviewer proceeds to questions in the module. If the patient answers 
“no” to a screening question, the interviewer will move forward accordingly to the subsequent 
module, following instructions in the structured interview. The Mini International 
Neuropsychiatric Interview-Plus version 7.0.2 (MINI-Plus 7.0.2) contains additional modules 
beyond what is included in the MINI 7.0.2. For this study, the MINI-Plus 7.0.2 module for 
Borderline Personality Disorder will be used. 
The MINI 7.0.2 is intended to meet the need for a short but accurate structured psychiatric 
interview for multicenter clinical trials and has an administration time of approximately 20-30 
minutes8. At Screening, the patients will be assessed for Schizophrenia as well as the lack of 
exclusionary psychiatric diagnoses by the MINI 7.0.2 and the MINI-Plus BPD 7.0.2. 
8.1.1.2 
Positive and Negative Syndrome Scale 
The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each 
symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence 
of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs 
for each subscale are as follows: 
1. Positive subscale (7 positive symptom constructs: delusions, conceptual disorganization, 
hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility)  
2. Negative subscale (7 negative symptom constructs: blunted affect, emotional withdrawal, 
poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of 
spontaneity and flow of conversation, stereotyped thinking) 
3. General psychopathology subscale (16 symptom constructs: somatic concern, anxiety, guilt 
feelings, tension, mannerisms and posturing, depression, motor retardation, 
uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment 
and insight, disturbance of volition, poor impulse control, preoccupation, and active social 
avoidance) 

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The PANSS will be administered using the clinician rated semi-structured interview via the 
SCI-PANSS. Instructions for administering this instrument will be provided to the site. PANSS 
will be administered first on visits when PANSS and CGI-S are being administered. 
8.1.1.3 
Placebo-Control Reminder Script 
The PCRS© Hassman and Cohen, 2019, Version 5.0 educates clinical trial subjects of key causes 
of the placebo and nocebo effects, level setting of the subject’s study expectations, reminding 
subjects what a placebo is and how that relates to their reporting of symptoms and potential side 
effects, and explaining how interactions with research site staff differ from their experience with 
clinical providers. The PCRS informs subjects that they are to be honest about their symptoms 
and that the site staff have no expectations of symptom improvement or worsening and will not 
be disappointed by the subject’s responses and asks subjects to explain in their own words PCRS 
content to ensure comprehension. The PANSS Rater will read the PCRS before administering the 
PANSS at each study visit. 
8.1.1.4 
Clinical Global Impressions-Severity of Illness Scale 
The severity of illness for each patient will be rated using the CGI-S. To perform this 
assessment, the rater or Investigator will answer the following question: “Considering your total 
clinical experience with this particular population, how mentally ill is the patient at this time?” 
Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 
3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most 
extremely ill patients.  
8.1.1.5 
Cogstate Computerized Battery of Tests 
The Cogstate Computerized Schizophrenia Battery of Tests is a measure of cognitive ability in 
subject with Schizophrenia in both the acute and chronic stages and will take approximately 22 
to 35 minutes to complete. Patients will have 1 practice session during the Screening Visit and 
complete the actual test on Day 1 (Baseline) and Day 28 (Visit 6) ET Visit). For each Cogstate 
test, the construct validity for cognitive impairment in Schizophrenia and sensitivity to change in 
cognition in such patients have been demonstrated in scientific literature. Patients perform the 
test on a provided laptop and then it is uploaded via a web-based portal. 
8.2 
Safety Assessments 
Tolerability will be assessed by reported and observed AEs. Frequency and severity of AEs will 
be summarized. 
Routine safety assessments will be performed throughout the study, with a final assessment 
performed when a patient completes the study on Day 42/Visit 7 or patient discontinues. (See in 
the SoA Table ). 
8.2.1 
Physical Examination and Height 
When required, a full physical examination will include examination of general appearance, skin, 
neck (including thyroid), eyes, ears, nose, throat, heart, lungs, abdomen, lymph nodes, 

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extremities, and nervous system. An AE form must be completed for all changes identified as 
clinically noteworthy. Height without shoes will be recorded in inches. At other time points as 
noted in the SoA, a brief or targeted exam that is focused on any changes since the previous 
exam may be conducted. 
8.2.2 
Vital Signs and Body Weight 
Vital signs will include body temperature, SBP, DBP, and heart rate. Blood pressure and heart 
rate will be measured in the following order: supine, sitting and standing after the patient has 
been in each position for at least 3 minutes. Vital signs scheduled for the same visit as blood 
sample have to be completed before blood is drawn.  
Body weight without shoes will be recorded in pounds.  
An AE form must be completed for all changes identified as clinically noteworthy. 
8.2.3 
Electrocardiogram 
Standard 12-lead ECGs (in triplicate) will be performed after the patient has been supine and at 
rest for ≥5 minutes. The captured ECGs must be separated by at least 1 minute. A central ECG 
service will be utilized to review all ECGs in order to standardize interpretations for the safety 
analysis. In addition, ECG results will be evaluated at the investigational site to monitor safety 
during the trial. Any Screening ECG with abnormal result(s) considered to be clinically 
significant should be repeated to confirm the finding(s) before excluding the patient from the 
trial. Patients will be randomized based on Screening ECG results from the central reader and 
Baseline ECG results from the trial site. If the Baseline ECG results from the central reader, 
when available, indicate a QTcF>450 msec at Baseline, the Investigator must contact the 
Medical Monitor to discuss the patient’s continued participation in the trial. ECGs scheduled for 
the same visit as blood samples are to be completed before blood is drawn. 
8.2.4 
Clinical Laboratory Tests 
The following clinical laboratory tests (samples are to be taken after an overnight fast of at least 
8 hours) are to be performed as indicated in the SoA (Table ):  
• Hematology: hemoglobin, hematocrit, red blood cell (RBC) count, white blood cell (WBC) 
count (with differential), and platelet count 
• Coagulation: PT, aPTT, and INR 
• Chemistry: albumin, albumin/globulin ratio, ALT, alkaline phosphatase, AST, 
bilirubin-direct, bilirubin-indirect, bilirubin-total, blood urea nitrogen, blood urea 
nitrogen/creatinine ratio, calcium, chloride, creatine kinase, creatinine, gamma-glutamyl 
transpeptidase, globulin, glucose, HbA1c, lactate dehydrogenase, phosphate, potassium, 
prolactin, sodium, total cholesterol, triglycerides, HDL, LDL, and uric acid 
• Urinalysis: pH of freshly voided specimen, specific gravity, protein, glucose, ketones, blood, 
and microscopic examination of the sediment 

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• Pregnancy tests: urine or serum pregnancy tests, only required for female patients of 
childbearing potential (e.g., not postmenopausal or surgically sterile [hysterectomy, bilateral 
oophorectomy, and/or bilateral salpingectomy])  
• Other: urine drug screen/blood alcohol test andTSH 
• ACTH and cortisol 
Laboratory samples will be analyzed by a central laboratory to ensure consistent interpretation of 
results. Additional details on the processing and shipment of specimens are provided in the 
Laboratory Manual. In the event of an unexplained clinically noteworthy abnormal laboratory 
test value, the test should be repeated immediately and followed up until it has returned to the 
normal range and/or an adequate explanation of the abnormality is found. 
8.2.5 
Adverse Events 
All AEs occurring after the patient signs the ICF and up to 14 days after the end of the Treatment 
Period will be recorded. 
See Section 9 for additional information. 
8.2.6 
Simpson-Angus Scale 
The SAS is a measure of EPS and consists of a list of 10 symptoms of Parkinsonism (gait, arm 
dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, 
glabella tap, tremor, and salivation). Each item will be rated on a 5-point scale, with a score of 0 
representing absence of symptoms, and a score of 4 representing a severe condition. The SAS 
total score is the sum of the scores for all 10 items. Anticholinergics, propranolol, 
benzodiazepines, and non-benzodiazepine sleep aids are not permitted within 12 hours of scale 
administration (see Section 6.7). Investigators are encouraged to delay scale administration until 
12 hours have elapsed, if at all possible. However, if delaying administration of the scale is not 
feasible, the SAS should still be administered and the use of the medication documented, 
including a notation of the drug name, dose, and time of administration in the eCRF. 
8.2.7 
Barnes Akathisia Rating Scale 
The BARS consists of 4 items related to akathisia: objective observation of akathisia by the 
Investigator, subjective feelings of restlessness by the patient, subjective distress due to 
akathisia, and global clinical assessment of akathisia. The first 3 items will be rated on a 4-point 
scale, with a score of zero representing absence of symptoms and a score of 3 representing a 
severe condition. The global clinical evaluation will be made on a 6-point scale, with 0 
representing absence of symptoms and a score of 5 representing severe akathisia. To complete 
this scale, patients will be observed while they are seated and then standing for a minimum of 
2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral 
conversation or engaged in activity on the ward) may also be rated. Subjective phenomena are to 
be elicited by direct questioning. Anticholinergics, propranolol, benzodiazepines, and 
non-benzodiazepine sleep aids are not permitted within 12 hours of scale administration 
(Section 6.7). Investigators are encouraged to delay scale administration until 12 hours have 

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elapsed, if at all possible. However, if delaying administration of the scale is not feasible, the 
BARS should still be administered and the use of the medication documented, including a 
notation of the drug name, dose, and time of administration in the eCRF. 
The BARS global score is defined as the global clinical assessment of akathisia. 
8.2.8 
Abnormal Involuntary Movement Scale 
The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral 
movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements 
(item 7) will be observed unobtrusively while the patient is at rest (e.g., in the waiting room), and 
the Investigator will also make global judgments on the patient’s dyskinesias (items 8 through 
10). Each item will be rated on a 5-point scale, with a score of 0 representing absence of 
symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 
10, awareness, severe distress). For this scale, the patient is to be sitting on a hard, firm chair. In 
addition, the AIMS includes 2 yes/no questions that address the patient’s dental status. The 
AIMS movement rating score is defined as the sum of items 1 through 7 (i.e., items 1 through 4, 
facial and oral movements; items 5 and 6, extremity movements; and item 7, trunk movements). 
Anticholinergics, propranolol, benzodiazepines, and non-benzodiazepine sleep aids are not 
permitted within 12 hours of scale administration. Investigators are encouraged to delay scale 
administration until 12 hours have elapsed, if at all possible. However, if delaying administration 
of the scale is not feasible, the AIMS should still be administered and the use of the medication 
documented, including a notation of the drug name, dose, and time of administration in the 
eCRF. 
8.2.9 
Columbia-Suicide Severity Rating Scale 
Suicidality will be monitored during the trial using the C-SSRS.  
The C-SSRS was developed by researchers at Columbia University as a tool to help 
systematically assess suicidal ideation and behavior during participation in a clinical trial of 
centrally acting drugs. The C-SSRS is composed of 5 questions addressing suicidal ideation, 
with sub-questions assessing the severity of ideation as well as 5 suicidal behavior categories 
(Completed Suicide, Actual Attempt, Interrupted Attempt, Aborted Attempt, and Preparatory 
Acts or Behavior). The tool is administered via interview with the patient (by a trained 
operator/interviewer). All attempts will be made to use the same interviewer for the same patient 
throughout the study. 
This study will use the “Baseline/Screening” and “Since Last Visit” versions of the scale. The 
“Baseline/Screening” version, which assesses the lifetime experience of the patient with suicide 
events and suicidal ideation and the occurrence of suicide events and/or ideation within a 
specified time period prior to entry into the trial, will be completed for all patients at the 
Screening Visit to determine eligibility (prior to the first dose). Risk for suicidal behavior during 
the study as determined by the Investigator’s clinical assessment and C-SSRS as confirmed by 
the following: answers “Yes” on items 4 or 5 (C-SSRS – Ideation) with the most recent episode 
occurring within the 6 months before Screening, or answers “Yes” to any of the 5 items (C-SSRS 
– Suicidal Behavior) with an episode occurring within the 12 months before Screening. This 

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assessment will be repeated at Baseline Visit (using the Since Last Visit” C-SSRS). The “Since 
Last Visit” C-SSRS form will be completed at all post-Screening visits. 
8.3 
Pharmacokinetic Assessments 
Details of the procedures to be followed for sample collection, storage, and shipment will be 
documented in a separate Laboratory Manual. 
These samples will not be used to assess biomarkers or genetic markers.  
PK plasma samples will be analyzed for concentrations of LB-102 and its metabolites, as 
applicable based on randomization. PK analyses will include the first 60 patients randomized in 
the study regardless of cohort and PK blood samples will be collected on Day 1, 8, and 21 at the 
following timepoints after the morning dose: 15 minutes, 30 minutes, 1, 2, 3, 4, 8, and 24 hours. 
On Day 1 only, a pre-dose PK blood sample will be collected.  
The following windows for PK collection are allowed: 
• Pre-dose PK can be drawn up to 60 minutes prior to first dose. 
• ± 5 minutes window on the 15 minutes, 30 minutes, 1, 2, 3, 4, 8 hours, PK collection times. 
• ±15 minutes window on 24-hour PK collection time. 
Note: The 24-hour PK must be drawn prior to next applicable dose. 
Plasma concentrations of LB-102 and metabolites (including amisulpride) will be measured 
during the study and PK parameters derived using noncompartmental or compartmental methods 
as appropriate. The following PK parameters (as appropriate) will be calculated: area under the 
concentration-time curve from time zero to time (AUC0-t), area under the concentration-time 
curve from time of dosing up to 24 hours (AUC0-24), area under the concentration-time curve 
from time zero to infinity (AUC0-inf), area under the concentration-time curve extrapolated from 
time t to infinity as a percentage of the total AUC (AUC%extrap), oral clearance (CL/F), maximum 
concentration (Cmax), time to reach Cmax (Tmax), terminal elimination rate constant (λz), and 
apparent terminal half-life (t½).  
No value for λz, AUC0-inf, CL/F, or t½ will be reported for cases that do not exhibit a terminal 
log-linear phase in the concentration versus time profile. 
No PK parameters will be calculated for patients with detectable concentrations for 2 or fewer 
time points. 
Individual and mean plasma concentration-time curves (both linear and log-linear) will be 
included in the final report. 
PK parameters of LB-102 and metabolites will be summarized by cohort using descriptive 
statistics (sample size, arithmetic means, geometric means, standard deviation [SD], % 
coefficient of variation [CV], minimum, median, and maximum). Figures will be created to 

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display mean and individual patient LB-102 and amisulpride concentration-time curves in 
plasma on both a linear and logarithmic scale. Dose proportionality will be assessed using linear 
regression, or another acceptable approach. 
 

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9 ADVERSE EVENT REPORTING 
9.1 
Definitions and Criteria 
9.1.1 
Adverse Events 
Per International Council for Harmonization of Technical Requirements for Pharmaceuticals for 
Human Use (ICH) E2A,2 an AE is “any untoward medical occurrence in a patient or clinical 
investigation patient administered a pharmaceutical product and which does not necessarily have 
to have a causal relationship with this treatment. An AE can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding, for example), symptom, or disease 
temporally associated with the use of a medicinal product, whether considered related to the 
medicinal product.” 
Medical interventions such as surgeries, diagnostic procedures, and therapeutic procedures are 
not AEs, but the action taken to treat the medical condition. They should be recorded as 
treatment(s) of the AEs. 
9.1.2 
Serious Adverse Events 
An SAE or a serious adverse drug reaction (ADR) is any untoward event that at any dose meets 
any of the following criteria: 
• Death 
• Life-threatening 
• Inpatient hospitalization or prolongation of existing hospitalization 
• Persistent or significant disability/incapacity 
• Congenital anomaly/birth defect in the offspring of a patient who received study drug 
• Other: important medical events that may not result in death, be life-threatening, or require 
hospitalization, may be considered an SAE when, based upon appropriate medical judgment, 
they may jeopardize the patient and may require medical or surgical intervention to prevent 1 
of the outcomes listed in this definition. Examples of such events are: 
o Intensive treatment in an emergency room or at home for allergic bronchospasm 
o Blood dyscrasias or convulsions that do not result in inpatient hospitalization 
o Development of drug dependency or drug abuse 
For deaths, the underlying or immediate cause of death should always be reported as an SAE. 
An AE is life-threatening if the patient was at immediate risk of death from the event; it does not 
refer to an event that hypothetically might have caused death if it were more serious. For 

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example, drug-induced hepatitis that resolved without evidence of hepatic failure would not be 
considered life-threatening even though drug-induced hepatitis can be fatal. 
All AEs requiring hospitalization should be considered SAEs. Hospitalization for elective 
surgery or routine clinical procedures that are not the result of AEs (e.g., elective surgery for a 
pre-existing condition that has not worsened) need not be considered AEs or SAEs. If anything 
untoward is reported during the procedure, that occurrence must be reported as an AE, either 
“serious” or “nonserious” according to the criteria outlined above. 
An AE is incapacitating or disabling if the experience results in a substantial and/or permanent 
disruption of the patient’s ability to carry out normal life functions. 
Any serious, untoward event that occurs subsequent to the reporting period that the Investigator 
assesses as related to study drug should also be reported and managed as an SAE. 
9.1.3 
Unexpected Adverse Drug Reactions 
An unexpected ADR is a reaction for which the nature or severity is not consistent with the 
applicable product information (Investigator’s Brochure [IB]). Until product information is 
amended, expedited reporting is required for additional occurrences of the reaction. Reports that 
add significant information on specificity or severity of a known, already documented SAE 
constitute unexpected events. For example, an event more specific or more severe than described 
in the IB would be considered “unexpected.” Specific examples would be (a) acute renal failure 
as a labeled ADR with a subsequent new report of interstitial nephritis, and (b) hepatitis with a 
first report of fulminant hepatitis. 
Guidance on reporting AEs and SAEs is described in Section 9.2. 
9.1.4 
Clinical Laboratory Changes 
Any abnormality in a laboratory value that is new in onset or which has worsened in severity or 
frequency from the Baseline condition and meets 1 of the following criteria will be recorded on 
the AE pages of the eCRF: 
• Requires therapeutic intervention or diagnostic tests 
• Leads to discontinuation of study drug 
• Has accompanying or inducing symptoms or signs 
• Is judged by the Investigator as clinically significant 
Combined elevations of aminotransferases and bilirubin, either serious or nonserious, and 
whether or not causally related, meeting the criteria of a potential Hy’s Law case (total bilirubin 
level ≥2 × ULN with simultaneously ALT or AST ≥3 × ULN) should always be reported to the 
Sponsor as soon as possible following the procedures outlined in Section 9.2.2 for SAE 
reporting, with the Investigator’s assessment of seriousness, causality, and a detailed narrative. 

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9.1.5 
Assessment of Severity 
Each AE will be classified according to the following criteria: 
Mild: 
The AE does not interfere in a significant manner with the patient’s 
normal level of functioning. 
Moderate: 
The AE produces some impairment of functioning, but is not 
hazardous to the patient’s health. 
Severe: 
The AE produces significant impairment of functioning or 
incapacitation and is a definite hazard to the patient’s health. 
Severity versus Seriousness: Severity is used to describe the intensity of a specific event while 
the event itself may be of relatively minor medical significance (such as severe headache). 
Severity is not the same as “seriousness,” which is based on patient/event outcome at the time of 
the event. 
When changes in the severity of an AE occur more frequently than once a day, the maximum 
severity for the experience should be noted. If the severity category changes over several days, 
those changes should be recorded as separate AEs (with distinct onset dates). 
9.1.6 
Assessment of Relationship 
Each AE will be assessed as to its relationship to the study drug, based on the following criteria. 
Although the attribution by the Investigator will be collected for reported events, for analytic 
purposes a temporal association with the use of the study drug will be assumed sufficient for at 
least plausible association. 
Not related: 
No causal relationship exists between the study drug and the AE, but 
an obvious alternative cause exists, e.g., the patient’s underlying 
medical condition or concomitant therapy. 
Possibly related: 
A connection with the administration of the study drug appears 
unlikely, but cannot be ruled out with certainty. An AE may be 
considered possibly related if or when it meets 2 of the following 
criteria: (1) it follows a reasonable temporal sequence from 
administration of the study drug; (2) it could not readily have been 
produced by the patient’s clinical state, environmental or toxic 
factors, or other modes of therapy administered to the patient; or 
(3) it follows a known pattern of response to the study drug. 
Related: 
There is a reasonable/plausible possibility that the AE may have been 
caused by the study drug. 
When assessing the relationship to the study drug, the following criteria will be considered: 
• Positive rechallenge 
• Positive dechallenge (resolution upon stopping the suspect study drug, in absence of other 
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• Known class effect 
• Biological plausibility 
• Lack of alternative explanation (e.g., a concomitant drug or disease) 
9.1.7 
Action Taken Regarding Study Drug 
The action taken regarding the study drug as a result of an AE should be selected from 1 of the 
categories listed below and recorded in the eCRF:  
• Dose Not Changed: No change in study drug dose was made. 
• Drug Interrupted: The study drug was temporarily stopped. 
• Drug Withdrawn: The study drug was permanently stopped. 
• Not Applicable: Patient died, study treatment had been completed prior to reaction/event, or 
reaction/event occurred prior to the start of treatment. 
• Unknown. 
9.1.8 
Other Action Taken for Event 
Other action(s) taken as a result of the AE should be selected from 1 of the categories listed 
below and recorded in the eCRF: 
• None (i.e., no treatment was required) 
• Therapy(ies) required (i.e., prescription and/or OTC medication was required to treat the AE) 
• Hospitalization or prolongation of hospitalization required (i.e., hospitalization was required 
or prolonged because of the AE, whether medication was required) 
• Other 
9.1.9 
Adverse Event Outcome 
The outcome of the AE should be selected from 1 of the categories listed below and recorded in 
the eCRF: 
• Recovered/Resolved (i.e., the patient fully recovered from the AE with no residual effect 
observed) 
• Recovering/Resolving (i.e., the AE improved but has not fully resolved) 
• Not Recovered/Not Resolved (i.e., the AE is still present and observable) 

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• Recovered/Resolved with Sequelae (i.e., the residual effects of the AE are still present and 
observable, including sequelae/residual effects) 
• Fatal (i.e., “fatal” should be used when death is a direct outcome of the AE) 
• Unknown 
9.2 
Reporting Procedures and Requirements 
9.2.1 
Adverse Events 
Each time the patient is seen or contacted by the Investigator or the study staff, be it at the study 
clinic, hospital, or over the telephone, the Investigator will determine whether any AE has 
occurred by evaluating the patient. AEs may be directly observed, reported spontaneously by the 
patient, or by questioning the patient at each contact. Patients should be questioned in a general 
way, without asking about the occurrence of any specific symptoms. If AEs occur, the first 
concern will be the safety of the study patients. All AEs will be followed until resolved or stable 
and the outcome documented in the patient’s source documentation/medical record, and in the 
eCRF.  
Any AE that occurs after the patient signs the ICF until 14 days after the end of the Treatment 
Period will be recorded in the patient’s source documentation/medical record and on the AE page 
of the eCRF. If the Investigator detects an AE in a patient after the last scheduled study visit and 
considers the event possibly related or related to prior study treatment, the Investigator should 
report it to the Sponsor or designated representative. 
Illnesses that are present at the time informed consent is given are to be regarded as concomitant 
illnesses and recorded in the medical history. Investigators should document all significant 
illnesses that the patient has experienced within 30 days of Screening as a prior illness. Illnesses 
first occurring or detected during the study and/or worsening of a concomitant illness during the 
study are to be documented as AEs.  
All clinical laboratory results, vital signs, and ECG results or findings should be evaluated by the 
Investigator to determine their clinical significance. Isolated abnormal clinical laboratory test 
results, vital sign findings, or ECG findings (i.e., not part of a reported diagnosis) should be 
reported as AEs if they are symptomatic, lead to study drug discontinuation or dose reduction, 
require corrective treatment, or constitute an AE in the Investigator’s clinical judgment. 
9.2.2 
Serious Adverse Events 
Each AE will be assessed to determine whether it meets seriousness criteria (Section 9.1.2). If 
the AE is considered serious, the Investigator should report this event to Worldwide 
pharmacovigilance and to the IRB according to its standard operating procedures (SOPs). 
If the Investigator detects an SAE in a study patient after the last scheduled study visit, and 
considers the SAE related or possibly related to this study’s study drug administration, the 
Investigator should report it to Sponsor or designated representative. 

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The Investigator must report to Worldwide all SAEs on the eCRF page within 24 hours of 
learning about the event regardless of relationship to study drug. If the site experiences a 
temporary disruption of the eCRF system, a back-up paper SAE Report Form will be available 
for site staff to complete. 
At minimum, the initial report of the SAE should include the following information: 
• AE description 
• Study code/protocol number 
• Patient number and year of birth 
• Study drug 
• Reporter name and contact information 
• Relationship to the study drug 
If the eCRF system is not available, the site staff will complete the back-up paper SAE Report 
Form and e-mail it within 24 hours to the following address: drugsafety@worldwide.com. 
In cases where the email system is unavailable, site staff will transmit the back-up paper SAE 
Report Form by fax to: +1-866-387-5539 (US). 
If notification is made via email or fax, site staff must enter the SAE information into the 
eCRF system as soon as the system becomes available. The original paper SAE Report Form 
submitted should be kept at the study site with the patient’s source documentation/medical 
record or in the site’s study files. 
If the SAE has not resolved at the time the Investigator submits an initial SAE report, the 
Investigator must provide a follow-up report as soon as the event resolves (or upon receipt of 
significant information if the event is still ongoing). Additional follow-up information must be 
reported in the eCRF within 24 hours of awareness following Investigator (or site) awareness of 
the information. The Investigator should not delay reporting an SAE in order to obtain additional 
information. Additional information, when available, should be reported per the reporting 
procedures described above. 
All SAEs shall be followed until resolution, until the condition stabilizes, or until the patient is 
lost to follow-up, or otherwise explained. Once the SAE is resolved, the corresponding AE eCRF 
page shall be updated. Additionally, any relevant laboratory test reports, consultation reports 
from other health care professionals, discharge summaries, or other information that has been 
gathered about the event shall be transmitted to the Sponsor and maintained in the patient’s 
source documentation/medical record.  
In the case of a “minimum report” (one that solely comprises the information bulleted above), a 
more detailed follow-up report should be sent as soon as more information becomes available but 
no later than 7 calendar days after the date of the initial report. For reported deaths, the 
Investigator should supply Worldwide and the IRB with any additional requested information 

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(e.g., autopsy reports and terminal medical reports). Additionally, any such reports shall be 
maintained in the patient’s source documentation/medical record. 
The Sponsor or its representative will be responsible for determining and in turn, reporting SAEs 
to regulatory authorities according to the applicable regulatory requirements. 
Any suspected unexpected serious adverse reaction must be reported according to applicable 
regulatory requirements.  
9.2.3 
Pregnancy During the Study 
If a patient, or the female partner of a male patient, becomes pregnant during the study, the 
Investigator will notify the Sponsor or designated representative immediately after the pregnancy 
is confirmed. The Investigator will report any pregnancies using the eCRF Pregnancy Reporting 
Form within 24 hours of becoming aware of the event. The Investigator will also (1) notify the 
patient’s physician that the patient was being treated with LB-102, and (2) follow the progress of 
the pregnancy and document the outcome of the pregnancy. Pregnancy outcome information 
should be forwarded to Sponsor or designated representative when available. 
Patients who become pregnant during the study will not be eligible for any further study 
treatments, the study drug will be discontinued immediately, and the patient will complete an ET 
Visit. The Investigator should make every effort to follow the patient until completion of the 
pregnancy and complete the Exposure in Utero (EIU) Reporting Form eCRF with complete 
pregnancy outcome information, including normal delivery and induced abortion. Any adverse 
pregnancy outcome, either serious or nonserious, should be reported in accordance with study 
procedures. If the outcome of the pregnancy meets the criteria for immediate classification as an 
SAE (i.e., post-partum complications, spontaneous or induced abortion, stillbirth, neonatal death, 
or congenital anomaly, including that of an aborted fetus), the Investigator should follow the 
procedures for reporting SAEs outlined in Section 9.2.2. In the event the eCRF system is 
unavailable, a back-up paper Pregnancy Reporting Form will be available for site staff to 
complete following the reporting guidelines as outlined in Section 9.2.2. 
For reports of pregnancy in the female partner of a male patient, the eCRF Pregnancy Report 
Form and EIU Reporting form (or SAE form if applicable) should be completed with the 
patient’s identification number and year of birth, and details regarding the female partner should 
be entered in the narrative section. The pregnancy outcome of the female partner should be 
followed and the reporting procedures outlined above (for pregnant patients) should be followed; 
however, consent should be received prior to the collection of any information via a pregnant 
partner ICF. The male partner may continue in the study after re-education and confirmation that 
recommended birth control methods per exclusion criteria are being used. 
 

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10 STATISTICS 
10.1 
General Procedures 
The statistical analysis will be undertaken by Worldwide in collaboration with LB 
Pharmaceuticals Inc. 
A detailed Statistical Analysis Plan (SAP) will be finalized and signed before database lock and 
before analysis of the study being carried out. Any deviations from the analyses described below 
will be included in the SAP, which will be included in the clinical study report. 
Continuous variables will be summarized by treatment using descriptive statistics (n, mean, 
median, SD, minimum, and maximum). For categorical variables, frequencies and percentages 
will be presented by treatment. Baseline is defined as the last observation prior to initiation of 
study medication. Details of the statistical analyses will be provided in the SAP. 
10.2 
Sample Size 
Approximately 350 patients will be randomized in a 3:3:3:1 ratio to placebo, LB-102 50 mg QD, 
LB-102 75 mg QD, or LB-102 100 mg QD, respectively, with 105 patients randomized to each 
of the first 3 arms and 35 to the last one (LB-102 100 mg). This will ensure at least 85% power at 
a 2-sided 5% significance level to detect a treatment difference on the primary endpoint of 8 
between either LB-102 50 mg or 75 mg and placebo QD, assuming a common SD of 18, an 
overall drop-out rate of 25% and a Hochberg procedure to adjust for multiplicity. The sample 
size was estimated via Monte Carlo simulations using 10,000 simulated trials. 
10.3 
Analysis Populations 
The following analysis populations are planned: 
• Safety Analysis Set: all randomized patients who receive study drug. Analyses based on this 
population will use the actual treatment received rather than the randomized one. 
• Intent-to-treat (ITT) Analysis Set: all randomized patients, irrespective of whether they 
receive the drug or not.  
• Modified Intent-to-treat (mITT) Analysis Set: all randomized patients with at least 1 dose of 
study drug. This will be the main analysis population for efficacy analysis purposes and 
patients will be analyzed based on the treatment they were randomized to. 
• Per-Protocol (PP) Analysis Set: all patients included in the mITT Analysis Set that do not 
have a major protocol violation. The PP Analysis Set will be used for supportive analyses of 
the primary and key secondary efficacy endpoints. 

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10.4 
Statistical Methods 
10.4.1 
Protocol Deviations 
All protocol deviations (PDs) will be assessed and documented on a case-by-case basis before 
database lock. PDs should be collected by site and grouped into different categories, such as: 
• Those who entered the study even though they did not satisfy the entry criteria; 
• Those who developed withdrawal criteria during the study but were not withdrawn; 
• Those who received the wrong treatment or incorrect dose; 
• Those who received a prohibited concomitant treatment. 
PDs that are considered to have an impact on the primary and some secondary efficacy variables, 
will be considered to be major PDs and will lead to exclusion of the patient from the PP Analysis 
Set. The deviations that might lead to this exclusion will be detailed in a Protocol Deviation 
Handling Plan and a full list of such occurrences will be provided in the Appendix 16.2 of the 
CSR (clinical study report). 
10.4.2 
Patient Disposition 
Details for the reasons and number of the Screening failures will be tabulated. Patient disposition 
will include the number of patients who enroll in the study and the number and percentage of 
patients included in each analysis set by treatment group. The frequency and percentage of 
patients who withdraw or discontinue from the study, along with the reason for withdrawal or 
discontinuation, as well as of those who complete the study, will be summarized by treatment 
group. 
In addition, for the PP Analysis Set only, the reason for exclusion from this analysis set will also 
be tabulated. 
10.4.3 
Demographic and Baseline Characteristics 
Treatment groups will be compared with respect to patient demographics and baseline 
characteristics using descriptive statistics only. Demographics and Baseline characteristics, 
including age, sex, race, weight, height, BMI, and disease history (duration, etc.) will be 
summarized by treatment group for the Safety Analysis Set. 
10.4.4 
Analysis of Efficacy 
10.4.4.1 
Estimand 
For the definition of the main study estimand, the following intercurrent events (ICEs) have been 
deemed as relevant: 
a) Taking a prohibited medication prior to Week 4 

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b) Starting an emergency treatment prior to Week 4 
The primary estimand for all the above events will follow the treatment-policy strategy, to 
estimate the difference in means (population-level summary) between any active dose of LB-102 
and placebo (treatment) in adult patients with acute schizophrenia as defined by the 
inclusion/exclusion criteria (population) for change from Baseline to Week 4 in the PANSS total 
score (variable) regardless of the occurrence of the above-mentioned ICEs.  
10.4.4.2 
Primary Efficacy Endpoint 
The primary endpoint is the change from Baseline to Week 4 in the PANSS total score. The null 
and alternative hypothesis for each dose level are as follows: 
H0: the difference in the change from Baseline to Week 4 in the PANSS total score between 
LB-102 active treatment and placebo is equal to 0; 
H1: the difference in the change from Baseline to Week 4 in the PANSS total score between 
LB-102 active treatment and placebo is different from 0.  
All efficacy endpoints will be analyzed for the mITT Analysis Set, and the primary endpoint will 
also be analyzed for the PP Analysis Set. 
Principal Analysis 
In line with the estimand definition, all data collected after the occurrence of an ICE will be 
included in the primary efficacy analysis. As a primary analysis, all missing data due to study 
discontinuation for lack of efficacy or drug-related AEs will be imputed assuming a Missing Not 
At Random (MNAR) mechanism and assuming that after withdrawal the subjects revert to the 
distribution of the worst PANSS score values observed up to time of discontinuation, whereas 
missing data due to discontinuation for any other reason, will be imputed under a Missing At 
Random (MAR) assumption using a Multiple Imputation (MI) approach.  
The primary efficacy endpoint (change from Baseline to Week 4 on the PANSS total score) will 
be analyzed using a Mixed Model for Repeated Measures (MMRM) approach, including site, 
visit, treatment, and their interaction as categorical covariates and Baseline PANSS as 
continuous covariates. Within -patient correlation across repeated measures will be accounted for 
by using an unstructured correlation, or the best fit structure should an unstructured matrix cause 
convergence issues. The differences between active treatment groups and placebo at Week 4 will 
be estimated alongside confidence intervals (CIs) and P values. The model will be fit separately 
for each imputed dataset and results pooled using Rubin’s rules to derive one treatment effect 
estimate. 
This analysis will be performed for the mITT and repeated for the PP Analysis Set. Should the 
mITT and ITT differ substantially (e.g., by at least 10%) the primary analysis will be performed 
for the ITT and the mITT only be regarded as supportive information. 

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A strategy for pooling sites enrolling a limited number of patients will be specified in the SAP 
prior to unblinding, and the derived ‘pooled study site’ variable used in all relevant statistical 
analyses. 
Sensitivity Analysis 
As a sensitivity analysis, missing data that was imputed under a MAR mechanism in the primary 
analysis will be imputed under a MNAR mechanism using a tipping-point approach to check 
robustness of the main analysis results. Details of the MI model for this and the main analysis as 
well as further sensitivity analyses will be provided in the SAP. 
The analysis model will be the same as for the primary analysis, with results obtained on each 
imputed dataset that will be pooled to provide a single measure of treatment effectiveness 
(alongside 95% CI and P values). 
Exploratory Analysis 
Further exploratory assessments might be performed to investigate heterogeneity of treatment 
effects across investigational sites, by summarizing the primary endpoint separately by study 
site. Subgroup Analysis 
Subgroups of interest will be defined based on BMI and severity of disease at Baseline (as 
measured by the PANSS total score). The primary and secondary endpoints will be descriptively 
analyzed within the relevant subgroup strata. 
10.4.4.3 
Secondary Efficacy Endpoint(s) 
All continuous secondary efficacy variables will be analyzed using similar approaches to what 
was described for the primary endpoint, using the appropriate Baseline measurement instead of 
the Baseline PANSS score, without any data imputation.  
The secondary efficacy endpoints to analyze in this way are the following: 
• Change from Baseline to Week 4 in CGI-S score 
• Change from Baseline to Week 4 in PANSS positive subscale score  
• Change from Baseline to Week 4 in PANSS negative subscale score  
• Change from Baseline to Week 4 in PANSS Marder factor scores  
The MMRM model for the above endpoints will allow to estimate the least square (LS) means 
and their difference between each active dose and placebo alongside their 95% CI and P values, 
which will only be displayed for informative/descriptive purposes (i.e., no multiplicity correction 
will be implemented). 
An additional exploratory endpoint is clinical response, defined as a reduction of ≥20% from 
Baseline in PANSS total score at Week 4. This will be analyzed consistently with a “composite 

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strategy” estimand, where a patient will be considered a responder if the criteria for clinical 
response are met and none of the ICEs mentioned above has occurred. For the purposes of this 
endpoint, only study discontinuations related to the treatment (e.g., lack of efficacy, AE related 
to the underlying condition such as worsening, etc.) will be considered as relevant ICEs and thus 
contribute to a non-responder status if occurring.  
This endpoint will be analyzed using a logistic regression model including treatment and 
Baseline PANSS score as covariates to estimate the odds ratio of response of any active dose vs 
placebo. 
10.4.4.4 
Exploratory Efficacy Endpoint 
The Cogstate Computerized Battery of Tests scores will be analyzed using an Analysis of 
Covariance (ANCOVA) model including site and treatment as categorical covariates and 
Baseline Cogstate score as continuous covariate. No imputations will be performed for missing 
data and similar quantities to compare treatments as for the primary analysis model (LS means 
and their differences across arms) will be presented. 
10.4.4.5 
Multiplicity 
Results from the analysis of the primary endpoint will be adjusted for multiplicity using a 
standard Hochberg procedure. This approach involves ranking the P values from the smallest 
(P(1)) to the largest (P(2)) and comparing the larger P value against 0.05 and if this hypothesis is 
rejected then even the other one is rejected, otherwise the smaller P values is tested against 
0.025. 
10.4.5 
Analysis of Safety 
All safety analyses will be performed using the Safety Analysis Set.  
10.4.5.1 
Extent of Exposure 
Extent of exposure will be summarized by treatment as number of drug administrations received 
and the overall duration of the exposure (from first to last dose) in days. 
10.4.5.2 
Adverse Events 
AEs will be characterized by type, severity, seriousness, and relationship to treatment. AEs will 
be coded by preferred term and system organ class (SOC) using Medical Dictionary for 
Regulatory Activities (MedDRA) Version 23.0.  
The incidence of TEAEs (number and percent of patients reporting the AE at least once during 
the study), SAEs, AEs related to study treatment, SAEs related to treatment, and AEs leading to 
study discontinuation will be summarized by treatment.  
A TEAE is defined as any AE that has an onset on or after the dose of study drug, or any 
pre-existing condition that has worsened on or after the first dose of study drug.  

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Any AE commencing after the last dose of study drug plus 14 calendar days will not be 
considered treatment-emergent. 
The incidence of TEAEs and treatment-related AEs will also be summarized by maximum 
severity and strongest relationship to study drug by MedDRA primary SOC and preferred term. 
The summary will include the total number and percentage of patients reporting a particular 
event as well as the total number of events. In counting the number of events reported, a 
continuous event, i.e., reported more than once and which did not cease, will be counted only 
once; noncontinuous AEs reported several times by the same patient will be counted as multiple 
events. 
Relative risks for the occurrence of any AE (i.e., at least 1 AE) during the course of the study as 
well as for each SOC/preferred term will be calculated for each LB-102 dose vs placebo 
alongside 95% CI and P values. For such analysis, a Poisson regression model with a log-link 
and a robust error variance will be considered, using the binary indicator for the presence of a 
given SOC/preferred term (or any AE) as response and treatment as the only covariate whose 
betas will be exponentiated to return the associated relative risk. 
10.4.5.3 
Electrocardiogram 
A list of patients with abnormal 12-lead ECG parameters will be presented. Baseline and change 
from Baseline in ECG parameters (heart rate, cardiac rhythm, PR interval, QRS interval, QT 
interval, and QTc interval) will be summarized at each post-Baseline time point.  
10.4.5.4 
Vital Signs 
Summary statistics for absolute vital sign value and the changes from Baseline will be presented 
by treatment group for each visit. 
10.4.5.5 
Physical Examination 
Physical examination data will be listed only. 
10.4.5.6 
Clinical Laboratory Tests 
Mean changes from Baseline at each post-Baseline time point for each laboratory variable will 
be presented. In addition, each reading will be classified as below, within, or above normal 
range, based on ranges supplied by the laboratory used. Shift tables for the Baseline and 
follow-up measurements will be presented. 
10.4.5.7 
Other Variables Related to Safety 
Other safety variables include the SAS, the BARS, the AIMS, and the C-SSRS.  
These scales will be summarized by treatment group and visit including, where appropriate, 
change from Baseline measures. 

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10.4.6 
Pharmacokinetics 
Data from patients who participated in the study will be included in the PK analysis. Patients 
with missing sample concentrations will be included in the PK analyses, provided their PK 
parameters can be adequately characterized based upon the remaining data. 
Deviation from procedures described in this protocol that impact the quality of data required to 
meet the objectives of the study will be documented and may result in the exclusion of PK data 
from the analyses for a particular patient. This includes any deviations or events that would 
invalidate the evaluation of the PK. Examples of deviations and events that could result in the 
exclusion of PK data from the analyses include emesis after dosing (within the predetermined 
time), sample processing, or assay errors that lead to inaccurate bioanalytical results. Other 
deviations or events that do not disqualify data from analyses may require minor adjustments to 
calculations. If these occur, data analyses will be adjusted and documented accordingly such that 
conclusions are not biased. An example of such an event includes, but is not limited to, minor 
deviations between the actual and scheduled time of sample collection. 
Other PK analyses may be performed as appropriate. 
Plasma concentrations of LB-102 and metabolites (including amisulpride) will be measured 
during the study and PK parameters derived using noncompartmental or compartmental methods 
as appropriate. The following PK parameters (as appropriate) will be calculated: AUC0-t, 
AUC0-24, AUC0-inf, AUC%extrap, CL/F, Cmax, Tmax, λz, and t½. 
No value for λz, AUC0-inf, CL/F, or t½ will be reported for cases that do not exhibit a terminal 
log-linear phase in the concentration versus time profile. 
No PK parameters will be calculated for patients with no detectable concentrations for 2 or fewer 
time points. 
Individual and mean plasma concentration-time curves (both linear and log-linear) will be 
included in the final report. 
PK parameters of LB-102 and metabolites will be summarized by cohort using descriptive 
statistics (sample size, arithmetic means, geometric means, SD, % CV, minimum, median, and 
maximum). Figures will be created to display mean and individual patient LB-102 and 
amisulpride concentration-time curves in plasma on both a linear and logarithmic scale. Dose 
proportionality will be assessed using linear regression, or another acceptable approach. 
10.4.7 
Interim Analysis 
No interim analysis is planned for this study. 

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11 STUDY MANAGEMENT AND RESPONSIBILITIES 
11.1 
Ethics 
11.1.1 
Good Clinical Practice 
The study will be performed in accordance with this protocol, local national laws (as applicable), 
ICH guideline for Good Clinical Practice (GCP),3 and the most recent guidelines of the 
Declaration of Helsinki.7  
11.1.2 
Institutional Review Board 
Conduct of the study must be approved by an appropriately constituted IRB. Approval is 
required for the study protocol, IB, protocol amendments, ICFs, patient information sheets, and 
advertising materials. No study drug will be shipped to a site until written IRB authorization has 
been received by the Sponsor or its representative. 
11.1.3 
Informed Consent 
For each study patient, a written ICF will be obtained before any protocol-related activities are 
performed. As part of this procedure, the Investigator or a designated representative must explain 
orally and in writing the nature, duration, and purpose of the study, and the action of the study 
drug in such a manner that the patient is aware of the potential risks, inconveniences, or adverse 
effects that may occur. Patients should be informed that they may withdraw from the study at 
any time. They will receive all information that is required by local regulations and ICH 
guidelines. The PI or a designated representative will provide the Sponsor or its representative 
with a copy of the IRB-approved ICF before the start of the study. 
Subjects will also be asked to provide additional consent for their participation in a secure, 
proprietary research subject database administered by VCT [Verified Clinical Trials, Garden 
City, NY]. The database will utilize partially identified subject information to review subjects’ 
research study history within the database. Participants who are identified as verification failures 
by VCT, should not be enrolled without documented approval from LB Pharmaceuticals and 
Worldwide. At the last subject contact, VCT staff will automatically close out the subject (safety 
follow-up, ET, or complete) based on the IXRS. 
11.1.4 
Confidentiality 
All information generated in this study is considered highly confidential and must not be 
disclosed to any person or entity not directly involved with the study unless prior written consent 
is gained from the Sponsor. However, authorized regulatory officials, IRB personnel, the 
Sponsor and its authorized representatives are allowed full access to the records. 
11.2 
Auditing and Monitoring 
To ensure accurate, complete, and reliable data, Worldwide will provide instructional material to 
the study sites and the Sponsor at a start-up training session to instruct the Investigators and 

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study coordinators. This session will give instruction in the protocol, the completion of the 
eCRFs, and study procedures.  
This study will be monitored for quality assurance at all stages of its development by the clinical 
research personnel employed by the Sponsor or its representative. A Monitoring Plan will be 
developed and approved by the Sponsor and Worldwide using a risk-based monitoring approach 
with the primary focus on critical data and processes that if inaccurate, not performed, or 
performed incorrectly, would threaten the protection of human patients or the integrity of the 
study results. Monitoring may include remote monitoring, personal visits, and/or telephone 
communication to assure that the investigation is conducted according to the protocol, SOPs, 
GCP guidelines, and applicable regulatory requirements. Quality control procedures will be 
applied to each stage of data handling to ensure that all data are reliable and have been processed 
correctly. As defined in the Monitoring Plan, eCRFs may be reviewed remotely or on-site for 
completeness, clarity, and consistency with source documents available for each patient. At the 
conclusion of the study, Worldwide will conduct a quality review of the database.  
The study may be audited by the Sponsor, Worldwide, and/or regulatory agencies at any time. 
Investigators will be given a notice before an audit occurs. 
Medical advisors and clinical research associates or assistants may request to witness patient 
evaluations occurring as part of this protocol. The Investigator and appropriate personnel will be 
periodically requested to attend meetings/workshops organized by the Sponsor to assure 
acceptable protocol execution. The study may be subject to audit by the Sponsor or by regulatory 
authorities. If such an audit occurs, the Investigator must agree to allow access to required 
patient records. By signing this protocol, the Investigator grants permission to personnel from the 
Sponsor, its representatives, and appropriate regulatory authorities for on-site monitoring of all 
appropriate study documentation, as well as on-site review of the procedures employed in the 
eCRF generation, where clinically appropriate. 
11.3 
Data Handling, Documentation, and Record Keeping 
11.3.1 
Source Documentation 
Note that a variety of original documents, data, and records for a given patient (e.g., hospital 
records, clinical and office charts, laboratory notes, memoranda, patient’s diaries or evaluation 
checklists, pharmacy dispensing records, recorded data from automated instruments, copies or 
transcriptions certified after verification as being accurate copies, microfiches, photographic 
negatives, microfilm or magnetic media, X-rays, patient files, and records kept at the pharmacy, 
at the laboratories, and at medico-technical departments involved in the clinical study) will be 
considered as source documents in this study. All study specific information obtained at each 
study visit must be recorded in the patient’s record (source documentation), and then entered into 
a validated EDC database by trained site personnel. 
11.3.2 
Direct Access to Source Data and Documents 
The Investigator/institution will provide direct access to source data and documents for 
trial-related monitoring, audits, IRB, and regulatory inspection. 

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11.3.3 
Record Retention 
The Investigator must arrange for retention of study records at the site. The nature of the records 
and the duration of the retention period must meet the requirements of the relevant regulatory 
authority but should not be less than 2 years after the first marketing approval. In addition, the 
retention period must meet the requirements of the most stringent authority. The Investigator 
should take measures to prevent accidental or premature destruction of these documents. 
11.3.4 
Study Documentation 
By signing a copy of the country-specific regulatory form(s), the PI or designated representative 
acknowledges that they have received a copy of the IB on LB-102 and assures the Sponsor that 
they will comply with the protocol and the provisions stated in the country-specific regulatory 
form(s). No changes in this protocol can be made without the Sponsor’s written approval. 
11.4 
Indemnification 
The Sponsor’s indemnification of the Investigator and institution during the conduct of this study 
is addressed in a letter of indemnification provided as a separate document. Other 
indemnification or insurance will be provided as necessary under local regulations. 
11.5 
Amendments 
Protocol modifications, except those intended to reduce immediate risk to study patients, may be 
made only by the Sponsor. A protocol change intended to eliminate an apparent immediate 
hazard to patients may be implemented immediately, provided the IRB is notified within 
5 calendar days. 
Any permanent change to the protocol must be handled as a protocol amendment. The written 
amendment must be submitted to the IRB and the Investigator must await approval before 
implementing the changes. The Sponsor will submit protocol amendments to the appropriate 
regulatory authorities for approval. 
If in the judgment of the IRB, the Investigator, and/or the Sponsor, the amendment to the 
protocol substantially changes the study design and/or increases the potential risk to the patient 
and/or has an impact on the patient's involvement as a study patient, the currently approved 
written ICF will require similar modification. In such cases, informed consent will be renewed 
for patients enrolled in the study before continued participation. 
11.6 
Study Discontinuation 
Both the Sponsor and the PI or designated representative reserve the right to terminate the study 
at the Investigator’s site at any time. Should this be necessary, the Sponsor or a specified 
designee will inform the appropriate regulatory authorities of the termination of the study and the 
reasons for its termination, and the PI or designated representative will inform the IRB of the 
same within the required time frame. In terminating the study, the Sponsor and the PI or 
designated representative will assure that adequate consideration is given to the protection of the 
patients’ interests. 

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12 PUBLICATION POLICY 
The Sponsor must review and approve any results of the study, abstracts or slide presentation for 
professional meetings prepared by the Investigator(s), before its submission. Published data must 
not compromise the objectives of the study. Data from individual study centers in multicenter 
studies must not be published separately. This review is required to ensure that the Sponsor is 
aware of all written and oral presentations of the data and does not imply any editorial review or 
restriction of the contents of the presentation or use. Authorship of any publication will agree 
with any other study Investigators and the Sponsor. In conformity with the Uniform 
Requirements for Manuscripts Submitted to Biomedical Journals published by the International 
Committee of Medical Journal Editors,4 Investigators whose contribution consists solely in the 
collection of data will not be named individually as authors. Rather, those Investigators will 
receive a collective authorship as the “LB-102 Study Group” and will be identified in a note. 

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13 REFERENCES 
1. Food and Drug Administration [Internet]. Guidance document, safety testing of drug 
metabolites. [cited 9 September 2021]. Available from: https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/safety-testing-drug-metabolites 
2. International Council for Harmonization. Clinical safety data management: definitions 
and standards for expedited reports, E2A. 27 Oct 1994 
3. International Council for Harmonization. Integrated addendum to ICH E6(R1): guideline 
for good clinical practice, ICH E6(R2). 09 Nov 2016. 
4. Kassirer JP, Angell M. On authorship and acknowledgments. N Engl J Med. 
1991;325(21):510-512.  
5. LB Pharmaceuticals Ltd LB-102 Investigator Brochure, Ed. 1, 25 Oct 2019 
6. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric 
Interview (M.I.N.I.): the development and validation of a structured diagnostic 
psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl. 20): 
22-33  
7. World Medical Association. World Medical Association declaration of Helsinki: ethical 
principles for medical research involving human subjects. JAMA. 2013;310(20):2191-
2194. doi:10.1001/jama.2013.281053. 
 

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14 APPENDICES 
14.1 
Names of Study Personnel 
The names of study personnel are provided in separate documentation to the site.  
Role 
Name and Contact Information 
Sponsor: 
 
Medical Monitor: 
 
CRO: 
 
Central Laboratory: 
 
ECG Central Facility: 
 
Abbreviations: CRO = contract research organization; ECG = electrocardiogram 
 
 

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14.2 
Phase 1 Clinical Data 
14.2.1 
Phase 1 LB-102-001 - Completed 
A randomized, double-blinded, placebo-controlled, single and multiple ascending dose study to 
evaluate the safety, tolerability, and PK of LB-102 administered orally to healthy volunteer 
(Protocol LB-102-001). 
This was a Phase 1, randomized double-blind, placebo-controlled study designed to evaluate the 
safety, tolerability, and PK of LB-102 in healthy volunteer. The study consisted of 2 parts: 
Part A – Single Ascending Dose (SAD) and Part B – MAD. There were 5 cohorts in Part A and 
3 cohorts in Part B. Each cohort consisted of 8 patients (n = 6 assigned to LB-102 treatment, and 
n = 2 assigned to placebo treatment). In Parts A and B, eligible healthy volunteers were 
randomized on Day 1 (pre-dose) to placebo (n = 2) or LB-102 (n = 6) treatment. Eligible healthy 
volunteers received 1 dose on Day 1 (Part A) or 13 doses on Days 1 to 7 (Part B) of placebo or 
LB-102. In Cohort 1 (Part A), dosing of the first 2 healthy volunteers (1 active and 1 placebo) 
commenced at least 24 hours prior to the remaining 6 healthy volunteers. Dosing of the 
remaining healthy volunteers in the cohort proceeded if no safety issues were identified for the 
first 2 healthy volunteers. Blood samples for PK and safety assessments were collected at 
nominal timepoints described below. Healthy volunteers were discharged on Day 3 (Part A) or 
Day 9 (Part B) and returned for a Follow-up Visit (Day 8 or Day 15, respectively) for safety 
review. For Cohort 5 (Part A), healthy volunteers returned for an additional Follow-up Visit.  
Safety Results 
LB-102 was generally well tolerated with all TEAEs either mild (37) or moderate (6) severity. 
Out of the 64 healthy volunteers, 28 healthy volunteers (50 mg QD, N = 4; 10 mg QD, N = 2; 
100 mg QD, N = 3; 200 mg QD, N = 3; 150 mg QD, N = 1; 50 mg BID, N = 2; 100 mg 
BID, N = 3; 75 mg BID, N = 5; placebo, N = 5) experienced at least 1 TEAE, with a total of 43 
TEAEs. Out of the 43 TEAEs, 29 (50 mg QD, N = 3; 10 mg QD, N = 1; 100 mg QD, N = 3; 
200 mg QD, N = 5; 150 mg QD, N = 1; 50 mg BID, N = 2; 100 mg BID, N = 5; 75 mg 
BID, N = 8; placebo, N = 1) were considered possibly, probably, or definitely related to 
treatment.  
Of the TEAEs definitely related to study drug, there were 11 cases of elevated prolactin 
(≥100 µg/L; 50 mg QD, N = 3; 10 mg QD, N = 1; 100 mg QD, N = 1; 150 mg QD, N = 1; 50 mg 
BID, N = 2; 100 mg BID, N = 1; 75 mg BID, N = 2), 4 cases of moderate dystonia (200 mg 
QD, N = 1; 100 mg BID, N = 2; 75 mg BID, N = 1), and 1 case of mild ECG QTcF prolongation 
(458 msec, 200 mg LB-102 QD) that were all resolved with either no course of action (prolactin 
increase and QTcF interval prolongation) or concomitant medications (dystonia). Due to 
2 TEAEs in the same SOC (acute dystonic reaction), treatment was halted in all healthy 
volunteers taking 100 mg LB-102 BID (Cohort 7) and the 2 healthy volunteers in Cohort 7 
taking placebo. As a result, the SRC decided to reduce the dose for Cohort 8 to 75 mg LB-102 
BID. Additionally, because QTcF interval was fairly prolonged from pre-dose values (20-
46 msec) in all healthy volunteers taking 200 mg LB-102 QD (Cohort 4), the dosage for Cohort 5 
was reduced to 150 mg LB-102 QD. Of the TEAEs probably or possibly related to study drug, 
there were 4 cases of nausea (100 mg LB-102 QD, N = 1; 200 mg LB-102, N = 1; 100 mg 

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LB-102 BID, N = 1; 75 mg LB-102 BID, N = 1) and 1 case of vomiting (100 mg LB-102 BID), 
urticaria (100 mg LB-102 QD), gastroesophageal disease (200 mg LB-102), insomnia (75 mg 
LB-102 BID), dizziness (75 mg LB-102 BID), and somnolence (75 mg LB-102 BID). 
Vital signs and physical examination results were largely unchanged from Baseline. Other than 
increases in prolactin, chemistry laboratory results were also relatively unchanged throughout 
study treatment. C-SSRS did not change during study treatment. 
Pharmacokinetics Results 
In Part A (SAD), LB-102 was rapidly absorbed and LB-102 concentration generally declined 
from peak in an apparent biphasic manner. The estimates of mean t½ of LB-102 generally ranged 
from 11.993 to 14.146 hours; exposure (as measured by Cmax, AUC0-t, and AUC0-inf) increased in 
a slightly greater than dose-proportional manner. Mean Cmax ranged from 24.1 ng/mL at the 
lowest dose of 10 mg LB-102 to 975.667 ng/mL at the highest dose of 200 mg LB-102. Mean 
AUC0-t ranged from 221.911 h•ng/mL at the lowest dose to 6709.821 h•ng/mL at the highest 
dose. Mean AUC0-inf ranged from 252.637 h•ng/mL at the lowest dose to 7002.109 h•ng/mL at 
the highest dose. Apparent clearance (CL/F) appeared to decrease as dose increased (42.44 L/h to 
28.89 L/h).  
In Part A (SAD), amisulpride was formed quickly over time after a single dose of LB-102 
(median Tmax, range = 2 to 3.5 hours) and generally declined with an approximate biphasic 
disposition of comparable shape to LB-102 but at approximately 2.5% of LB-102 abundance. 
The plasma concentrations of amisulpride at lower doses were within several fold of LLOQ 
making descriptive PK analysis tenuous. In fact, amisulpride was not detected in healthy 
volunteers taking 10 mg LB-102 QD (Cohort 2). Mean amisulpride t½ ranged from 
approximately 8.921 to 14.614 hours. Mean Cmax ranged from 4.167 ng/mL at the lowest 
detectable dose, 50 mg LB-102, to 27.747 ng/mL at the highest dose, 200 mg LB-102. Mean 
AUC0-t ranged from 31.183 h•ng/mL at the lowest detectable dose, 50 mg LB-102, to 
247.397 h•ng/mL at the highest dose, 200 mg LB-102. Mean AUC0-inf ranged from 
188.552 h•ng/mL at the lowest detectable dose, 100 mg LB-102, to 314.264 h•ng/mL at the 
highest dose, 200 mg LB-102.  
In Part B (MAD), extensive PK sampling occurred on Day 6 rather than Day 7 and the last dose 
was given on Day 7. Thus, the PK profile for the second dose on Day 6 (including the pre-dose 
on Day 7) was used to calculate the PK parameter after multiple doses. For the calculation of 
area under the concentration-time curve from time of dosing up to 12 hours (AUC0-12), Day 1, 
the actual time for the 12-hour sample was used in place of the nominal 12 hour since the 
concentration at 12 hours post-dose could not be predicted. In Part B (MAD), trough 
concentrations of LB-102 and amisulpride plateaued before the morning dose on Day 4. After 
multiple doses, there was slight to moderate accumulation of LB-102 across dose levels with 
mean accumulation ratio based on Cmax after the first dose and last dose (RCmax) values ranged 
from 1.121 to 1.798 and with mean accumulation ratio based on AUC after the first and last dose 
(RAUC) values ranged from 1.472 to 1.925. Amisulpride had a higher accumulation than 
LB-102 across dose levels with mean RCmax values ranged from 1.317 to 2.016 and with mean 
RAUC values ranged from 1.801 to 2.232. Exposure (as measured by Cmax, Day 7 and AUC0-12, 

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Day 7) to LB-102 increased in a dose-proportional manner. Apparent clearance at steady state 
(CLss/F) to LB-102 appeared to be similar as dose increased. 

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Table 14.1: 
Summary of Key Plasma LB-102 Pharmacokinetic Parameters – Pharmacokinetic Population 
PK Parameter 
Statistic 
10 mg LB-102 
(N = 6) 
50 mg LB-102 
(N = 6) 
100 mg LB-102 
(N = 6) 
150 mg LB-102 
(N = 6) 
200 mg LB-102 
(N = 6) 
Cmax (ng/mL) 
n 
6 
6 
6 
6 
6 
Mean (SD) 
24.1 (10.728) 
176 (52.786) 
348.167 (141.832) 
596.5 (117.527) 
975.667 (253.995) 
GM (GM CV%) 
22.292 (44.5) 
169.502 (30.8) 
322.891 (45.6) 
585.831 (21.7) 
949.831 (25.4) 
Tmax (h) 
n 
6 
6 
6 
6 
6 
Median  
(min, max) 
3 (3, 3) 
3 (2, 4) 
3.01 (1, 4) 
3 (3, 4) 
1.75 (1.5, 3) 
λz (l/h) 
n 
6 
6 
6 
6 
6 
Mean (SD) 
0.054 (0.01411) 
0.0592 (0.00877) 
0.0521 (0.0136) 
0.0591 (0.00945) 
0.0569 (0.01591) 
t½ (h) 
n 
6 
6 
6 
6 
6 
Mean (SD) 
13.75 (3.9375) 
11.933 (1.7797) 
14.146 (3.9617) 
11.969 (1.8897) 
12.997 (3.5854) 
AUC0-t 
(ng•h/mL) 
n 
6 
6 
6 
6 
6 
Mean (SD) 
221.911 (69.4093) 
1526.08 (176.5906) 
2636.04 (481.5386) 
4490.161 (741.2812) 
6709.821 (834.9332) 
GM (GM CV%) 
212.353 (35.1) 
1517.497 (11.7) 
2594.86 (20.2) 
4439.9 (16.5) 
6668.19 (12.2) 
AUC0-24 
(ng•h/mL) 
n 
6 
6 
6 
6 
6 
Mean (SD) 
198.807 (66.9513) 
1336.105 (167.6764) 
2303.664 (533.1684) 
4067.23 (685.9163) 
5983.093 (833.9816) 
GM (GM CV%) 
189.498 (35.1) 
1327.048 (12.9) 
2244.225 (26.5) 
4019.483 (17) 
5938.059 (13.3) 
AUC0-inf 
(ng•h/mL) 
n 
6 
6 
6 
6 
6 
Mean (SD) 
252.637 (69.857) 
1595.938 (189.1599) 
2809.785 (477.7622) 
4363.577 (745.7299) 
7002.109 (820.7252) 
GM (GM CV%) 
244.171 (29.7) 
1586.584 (11.9) 
2773.559 (18.1) 
4587.238 (16.1) 
6962.173 (11.8) 
CL/F (L/h) 
n 
6 
6 
6 
6 
6 
Mean (SD) 
42.44 (12.598) 
31.7 (3.794) 
36.56 (6.935) 
33.05 (5.25) 
28.89 (3.381) 
Abbreviations: AUC0-24 = area under the concentration-time curve up to 24 hours; AUC0-inf = area under the concentration-time curve from time zero to infinity; AUC0-t = area 
under the concentration-time curve from time zero to time; CL/F = oral clearance; Cmax = maximum concentration; CV = coefficient of variation; GM = geometric mean; 
h = hours; λz = terminal elimination rate constant; mg = milligram; ng/mL = nanogram per milliliter; PK = pharmacokinetic; SD = standard deviation; t½ = apparent terminal half-
life; Tmax = time to reach maximum concentration  

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Summary – Conclusions 
LB-102 was well tolerated with all TEAEs either mild or moderate severity. The most notable 
safety result was mildly elevated prolactin levels, which was expected to occur based on 
LB-102’s mechanism of action as a dopamine antagonist and that it is a commonly reported AE 
for drugs of this class.1 At the highest dose (200 mg LB-102), QTcF prolongation was noted; 
however, predefined stopping criteria were not met. In addition, acute dystonic reaction was 
reported in 200 mg LB-102 QD (which resulted in this dose being discontinued) and 75-100 mg 
LB-102 BID. There were no significant TEAEs at the lower doses.  
For PK results in Part A (SAD), LB-102 was rapidly absorbed and LB-102 concentration 
generally declined from peak in an apparent biphasic manner. Exposure increased in a slightly 
greater than dose-proportional manner. Apparent clearance appeared to decrease as dose 
increased. Minor (as defined by the FDA)1 amounts of amisulpride, approximately 2.5% of 
LB-102, were detected in plasma samples. The plasma concentrations of amisulpride at lower 
doses were within several fold of LLOQ making descriptive PK analysis tenuous. For PK results 
in Part B (MAD), trough concentrations of LB-102 and amisulpride plateaued before the 
morning dose on Day 4. After multiple doses, there was slight to moderate accumulation of LB-
102 across dose levels. 
Amisulpride had a higher accumulation than LB-102 across dose levels. Exposure to LB-102 
increased in a dose-proportional manner. Apparent clearance at steady state to LB-102 appeared 
to be similar as the dose increased. LB-102 was designed to be an improved version of 
amisulpride by having increased permeability across the blood-brain-barrier, which would 
potentially decrease the plasma concentrations needed to achieve efficacy. This would thereby 
decrease the magnitude and frequency of AEs typically observed in schizophrenia patients 
treated with amisulpride. The MTD of LB-102 was identified as 150 mg per day as either 
150 mg QD or 75 mg BID. LB-102-001 achieved its objectives of identifying the safety, 
tolerability, and PK of a single oral dose and multiple oral doses of LB-102 in healthy volunteer. 

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14.3 
Exclusionary Laboratory Results for Screening 
Table 14.2: 
Important Exclusionary Criteria for Screening 
Diabetes 
Patients with insulin-dependent diabetes mellitus (i.e., any patients using insulin) are excluded. Patients with 
non-insulin-dependent diabetes mellitus may be eligible for the trial if their condition is stable as determined by 
satisfying ALL of the following criteria: 
• 
HbA1c <7.0%, and 
• 
Screening glucose must have been ≤125 mg/dL or ≤6.94 mmol/L (fasting) or <200 mg/dL or 
<11.1 mmol/L (non-fasting). If the non-fasting Screening glucose was ≥200 mg/dL or ≥11.1 mmol/L, 
patients must have been retested in a fasted state, and the retest value must have been ≤125 mg/dL or 
≤6.94 mmol/L, and 
• 
Patient had been maintained on a stable regimen of oral antidiabetic medication(s) for at least 28 days 
prior to Screening or diabetes had been well controlled by diet for at least 28 days prior to Screening, 
and 
• 
Patient had no hospitalizations within the 12 months prior to Screening due to diabetes or complications 
related to diabetes, and 
• 
Patient’s diabetes should not be newly diagnosed during Screening for the trial. 
 
Laboratory 
• 
Platelets ≤75,000/µL or ≤75×109/L 
• 
Hemoglobin ≤9 g/dL or ≤90 g/L 
• 
Neutrophils, absolute ≤1000/µL or ≤1×109/L 
• 
Aspartate transaminase (AST) >2 × ULN 
• 
Alanine transaminase (ALT) >2 × ULN  
• 
Creatine phosphokinase (CPK) >3 × ULN, unless discuss with and approve by the Medical Monitor 
• 
Creatinine ≥2 mg/dL or ≥176.8 µmol/L 
• 
Estimated creatinine clearance of <45 mL/min, calculated using the Cockcroft-Gault equation, at 
Screening 
• 
HbA1c ≥7.0%  
• 
Abnormal free T4 (during Screening), unless discussed with and approve by the Medical Monitor. 
(Note: Free T4 will be measured only if the result for TSH is abnormal.) 
ECG Results 
Clinically significant abnormal finding on the triplicate set of ECGs or evidence of any of the following cardiac 
conduction abnormalities at Screening (mean values will be used for the following criteria): 

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• 
Heart rate <40 bpm or >110 bpm (based on the ECG reading). NOTE: The Medical Monitor should be 
contacted in any instance where the Investigator is uncertain regarding the stability of a patient’s medical 
condition(s) and the potential impact of the condition(s) on trial participation 
• 
QTcF interval >450 msec for males and females 
• 
PR interval ≥200 msec 
• 
Intraventricular conduction delay with QRS duration >120 msec 
• 
Evidence of second- or third-degree AVB 
• 
Electrocardiographic evidence of complete LBBB, complete RBBB, or incomplete LBBB 
 
 
 
 
 

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14.4 
Half-Life of Major Psychiatric Medications 
The recommended duration of the washout period should be 5 × the duration of the known half-
life of the drug. 
Medication 
Half-life after oral administration (hours) 
Antipsychotics 
Second Generation Antipsychotics 
Aripiprazole 
75-94 
Asenapine 
24 
Brexpiprazole 
91 
Cariprazine 
48-96 (parent drug) 
7-21 days (active metabolites) 
Clozapine 
12 
Iloperidone 
18-26 
Lurasidone 
29-37 (at steady state) 
Olanzapine 
30-38 
Paliperidone 
23 
Pimavanserin 
57 parent drug  
(200 for active metabolite) 
Quetiapine 
6-12 
Risperidone 
20 
Ziprasidone 
7 oral 
2-5 IM 
First Generation Antipsychotics 
Chlorpromazine 
30 
Fluphenazine 
33 
Haloperidol 
20 
Loxapine 
6-8 (parent drug) 
12 (active metabolites) 
Perphenazine 
9-12 (parent drug) 
10-19 (active metabolite) 
Pimozide 
55 
Thiothixene 
34 

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Thioridazine 
4-10 (parent drug) 
21-25 (active metabolites) 
Trifluoperazine 
3-12 (parent drug) 
22 (active metabolites) 
Antidepressants 
Selective Serotonin Reuptake Inhibitors (SSRI) 
Citalopram 
Escitalopram 
Paroxetine 
Sertraline 
20-30 
Fluoxetine 
1-3 days 
Fluvoxamine 
15 
Serotonin-norepinephrine (SNRI) reuptake inhibitors 
Desvenlafaxine 
9-11 
Duloxetine 
10-12 
Levomilnacipran ER 
12 
Milnacipran 
8-10 
Venlafaxine 
5 (parent) 
11 (active metabolites) 
Tricyclics 
Amitriptyline 
9-25 
Imipramine 
19 
Clomipramine 
12-36 
Doxepin 
3-80 
Nortriptyline 
36 
Monoamine oxidase inhibitors (MAOIs) 
Tranylcypromine 
2 
Phenelzine 
12 
Isocaroxazid 
36 
Moclobemide 
2-4 
Other 
Mirtazapine 
20-40 

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Agomelatine 
1-2 
Reboxetine 
13 
Vortioxetine 
66 
Benzodiazepines 
Alprazolam 
12-15 
Lorazepam 
10-20 
Oxazepam 
6-20 
Diazepam 
36-200 
Chlordiazepoxide 
3 -200 
Temazepam 
5-15 
Nitrazepam 
24-40 
Non-Benzodiazepine Anxiolytics 
Buspirone 
2-11 
Pregabalin 
6  
Antiepileptics 
Carbamazepine 
12-27 
Gabapentin 
5-7  
Lamotrigine 
15-35  
Levetiracetam 
6-8  
Oxcarbazepine 
8-15  
Pregabalin 
5-7  
Topiramate 
20-30  
Vigabatrin 
5-8  
Valproic acid 
6-17