Clinical trial NCT04228302
Conditions: Healthy Adults
Sponsor: EicOsis Human Health Inc.
Start date: 2019-12-09; Completion date: 2020-07-07
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a first-in-human study with EC5026, a new drug candidate intended to treat neuropathic pain. The purpose of the study is to provide initial safety, tolerability, and pharmacokinetics data of single ascending oral doses of EC5026 in healthy subjects.

Detailed description:
This is a single-center, double-blind, placebo-controlled, Phase 1a single ascending dose study evaluating the safety, tolerability and pharmacokinetics of sequential doses of oral EC5026 in healthy male and female subjects. EC5026 is an inhibitor of the soluble Epoxide Hydrolase (sEH) enzyme developed as a first-in-class analgesic for the treatment of pain. This study will help refine the dosing strategy for subsequent multiple-dose studies in healthy subjects and for future clinical trials in patients with neuropathic pain.

sEH is an enzyme that is downstream in the cytochrome P450 (CYP) pathway of the arachidonic acid (AA) cascade. The sEH enzyme is responsible of metabolizing a class of epoxy-fatty acids known as epoxyeicosatrienoic acids (EETs), which are potent, naturally occurring analgesics. EETs are produced at high concentrations in areas of tissue damage and inflammation, but are rapidly metabolized by the sEH enzyme into inactive compounds. Effective inhibition of sEH activity prolongs the ability of EETs to exert their analgesic activity.

Arms: arm 1: Single Ascending Doses of oral EC5026 arm 2: Single doses of matching oral placebo
Interventions: intervention 1: EC5026 oral capsule intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: 5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort).

Oral doses of EC5026 tested in each cohort: 0.5 mg (Cohort 1), 2 mg (Cohort 2), 8 mg (Cohort 3), 16 mg (Cohort 4), and 24 mg (Cohort 5).

A blinded sentinel group of 2 subjects (1 active and 1 placebo) will be dosed at least 2 days before the remaining 6 subjects (5 active and 1 placebo) will receive blinded doses of active study drug or placebo. intervention 2: 5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort)

Protocol documents:
Prot_000.pdf: 
Sponsor: 
Sponsor Contact: 
Medical Monitors: 
Version of Protocol: 
Date of Protocol: 
CLINICAL STUDY PROTOCOL 
IND 142,184 
NCT04228302
A SINGLE-CENTER, DOUBLE-BLIND, PLACEBO-
CONTROLLED, PHASE lA SINGLE ASCENDING DOSE STUDY 
TO INVESTIGATE THE SAFETY, TOLERABILITY, AND 
PHARMACOKINETICS OF SEQUENTIAL DOSE REGIMENS OF 
ORAL EC5026 IN HEALTHY MALE AND FEMALE SUBJECTS 
PROTOCOL NO. EC5026-1-01 
EicOsis Human Health, Inc. 
140 B Street 
Suite 5, Number 346 
Davis, CA 95616 
2.0 
15 October 2019 
CONFIDENTIAL 
The concepts and information contained in this document or generated during the study are 
considered proprietary and may not be disclosed in whole or in part without the expressed, 
written consent of EicOsis Human Health, Inc. 
The study will be conducted according to the International Council for Harmonisation 
Guideline E6(R2): Good Clinical Practice. 





























































































SAP_001.pdf: 
  
 
 
 
 
 
 
 
 
 
EicOsis Human Health, Inc. 
 
EC5026-1-01 
 
NCT04228302 
 
A Single-Center, Double-Blinded, Placebo-Controlled, Phase 1A Single 
Ascending Dose Study to Investigate the Safety, Tolerability, and 
Pharmacokinetics of Sequential Dose Regimens of Oral EC5026 in 
Healthy Male and Female Subjects 
 
21JAN2020 
 
Statistical Analysis Plan 
 
Final Version 1.0 
 
Prepared by: 
 
PPD 
3900 Paramount Parkway 
Morrisville, NC 27560 USA 
 


EicOsis Human Health, Inc 
 
Draft Statistical Analysis Plan, Version 1.0 
EC5026-1-01 
 
Date Issued: 21JAN2020 
 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ........................................................................................... IV 
1. 
INTRODUCTION ....................................................................................................1 
2. 
OBJECTIVES ...........................................................................................................1 
2.1. PRIMARY OBJECTIVES ............................................................................................... 1 
2.2. EXPLORATORY OBJECTIVES ...................................................................................... 1 
3. 
INVESTIGATIONAL PLAN ..................................................................................1 
3.1. OVERALL STUDY DESIGN AND PLAN ........................................................................ 1 
3.2. STUDY ENDPOINTS .................................................................................................... 3 
3.2.1. 
Pharmacokinetic Endpoints .............................................................................. 3 
3.2.2. 
Safety Endpoints ................................................................................................ 3 
3.2.3. 
Pharmacodynamic Endpoints ........................................................................... 3 
4. 
GENERAL STATISTICAL CONSIDERATIONS ...............................................3 
4.1. SAMPLE SIZE ............................................................................................................. 4 
4.2. ANALYSIS POPULATIONS .......................................................................................... 4 
5. 
SUBJECT DISPOSITION, PROTOCOL DEVIATIONS, AND FOLLOW-UP
 ....................................................................................................................................5 
5.1. DISPOSITION ............................................................................................................. 5 
5.2. PROTOCOL DEVIATIONS ............................................................................................ 5 
6. 
DEMOGRAPHICS AND BASELINE CHARACTERISTICS ............................5 
6.1. DEMOGRAPHICS ........................................................................................................ 5 
6.1.1. 
Medical History ................................................................................................. 6 
7. 
TREATMENTS, MEDICATIONS, AND MEALS ...............................................6 
7.1. PRIOR AND CONCOMITANT MEDICATIONS ................................................................ 6 
7.2. MEDICAL AND SURGICAL TREATMENT PROCEDURES ............................................... 6 
7.3. STUDY DRUG ADMINISTRATION ............................................................................... 7 
8. 
PHARMACOKINETIC ANALYSIS .....................................................................7 
8.1. DATA HANDLING ...................................................................................................... 7 
8.2. PLASMA CONCENTRATIONS ...................................................................................... 7 
8.3. URINE CONCENTRATION ........................................................................................... 8 
8.4. PLASMA PHARMACOKINETIC PARAMETERS .............................................................. 8 
8.5. URINE PHARMACOKINETIC PARAMETERS ................................................................. 9 
8.6. PHARMACOKINETIC STATISTICAL ANALYSIS ........................................................... 10 
9. 
PHARMACODYNAMICS ....................................................................................10 
10. 
SAFETY ANALYSIS .............................................................................................10 


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10.1. 
ADVERSE EVENTS ................................................................................................ 10 
10.1.1. 
Incidence of Adverse Events ........................................................................ 11 
10.1.2. 
Relationship of Adverse Events to Study Drug ............................................ 11 
10.1.3. 
Severity of Adverse Event ............................................................................. 12 
10.1.4. 
Serious Adverse Events ................................................................................ 12 
10.1.5. 
Adverse Events Leading to Study Drug Discontinuation ............................. 13 
10.2. 
CLINICAL LABORATORY EVALUATIONS .............................................................. 13 
10.3. 
VITAL SIGN MEASUREMENTS AND WEIGHT ........................................................ 13 
10.4. 
ELECTROCARDIOGRAMS ...................................................................................... 14 
10.4.1. 
12-Lead ECG ............................................................................................... 14 
10.4.2. 
ECG Telemetry ............................................................................................. 14 
10.5. 
PHYSICAL EXAMINATION .................................................................................... 14 
11. 
CHANGES FROM THE PLANNED ANALYSIS ..............................................15 
12. 
INTERIM ANALYSIS ...........................................................................................15 
13. 
REFERENCES .......................................................................................................15 
14. 
APPENDICES ........................................................................................................16 
APPENDIX 1 SCHEDULE OF EVENTS .................................................................................. 16 
APPENDIX 2 CLINICAL LABORATORY ASSESSMENTS .......................................... 20 


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List of Abbreviations 
λz 
apparent terminal elimination rate constant 
%AUCextrap 
percentage of the area extrapolated for calculation of AUC0-inf 
Ae 
amount of drug excreted unchanged in the urine 
AE 
adverse event 
ANOVA 
analysis of variance 
AUC0-48 
area under the serum concentration-time curve from time 0 to 48 
hours postdose 
AUC0-t 
area under the curve from time 0 to time t 
AUC0-∞ 
extrapolation of the area under the curve from time 0 to infinity 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
BLQ 
below the limit of quantification 
BMI 
body mass index 
BP 
blood pressure 
Clast 
the last quantifiable plasma drug concentration 
CI 
confidence interval 
CL 
total serum clearance 
CL/F 
apparent total body clearance 
CLr 
renal clearance 
Cmax 
maximum (peak) serum drug concentration 
CSR 
clinical study report 
CRU 
clinical research unit 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EicOsis 
EicOsis Human Health, Inc. 
EOS 
end of study 
ET 
early termination 
FDA 
Food and Drug Administration 
Fe% 
fraction of dose excreted in urine 
Fe % t1-t2 
fraction of the administered dose excreted in urine over each 
collection interval 
GLP 
Good Laboratory Practice 
HR 
heart rate 
Kel 
apparent terminal elimination rate constant 
MedDRA 
Medical Dictionary for Regulatory Activities 
PD 
pharmacodynamic 
PK 
pharmacokinetic(s) 
PT 
preferred term 
QTcF 
QT interval corrected for heart rate using Fridericia’s formula 


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RR 
time elapsed between 2 consecutive R waves as measured by 
electrocardiogram 
Rsq 
r2, the coefficient of determination (goodness of fit statistic) 
SAD 
single ascending dose 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
standard deviation 
SoA 
schedule of activities 
SOC 
system organ class 
SRC 
Safety Review Committee 
t1/2 
apparent terminal half life 
TEAE 
treatment-emergent adverse event 
Tmax 
time to reach maximum observed serum concentration 
ULN 
upper limit of normal 
Vz/F 
apparent volume of distribution 
 


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1. Introduction 
 
This document outlines the statistical methods to be implemented during the analysis of 
data collected within the scope of EicOsis, protocol EC5026-1-01 (A Single-Center, 
Double-Blinded, Placebo-Controlled, Phase 1A Single Ascending Dose Study to 
Investigate the Safety, Tolerability, and Pharmacokinetics of Sequential Dose Regimens of 
Oral EC5026 in Healthy Male and Female Subjects), Version 2.0, 15 October 2019.  
 
This is a Phase 1A, first-in-human study with EC5026 and is designed to provide initial 
safety, tolerability, and pharmacokinetics (PK) data regarding EC5026 for future clinical 
studies. Analysis of urine and plasma concentrations of EC5026 will characterize the 
single-dose PK of EC5026 and help to refine the dosing strategy for subsequent multiple-
dose studies. 
 
The purpose of this statistical analysis plan is to define the planned statistical analysis of 
the study data consistent with the study objectives. 
2. Objectives 
2.1. Primary Objectives 
 
The primary objectives of this study are as follows: 
• To investigate the safety and tolerability of escalating dose regimens of EC5026 
administered once orally in healthy male and female subjects. 
• To investigate the PK of escalating dose regimens of EC5026 administered once 
orally in healthy male and female subjects. 
2.2. Exploratory Objectives 
 
The exploratory objectives of this study are as follows: 
• To investigate the response of various biomarkers to a single dose of EC5026 
administered to healthy male and female subjects. 
• To investigate putative metabolites of EC5026 following single oral administration 
of EC5026 in healthy male and female subjects. 
3. Investigational Plan 
3.1. Overall Study Design and Plan 
 
This is a Phase 1A, first-in-human, randomized, single-center, double-blind, 
placebo-controlled, single ascending dose (SAD) study to investigate the safety, 
tolerability, and PK of EC5026 in healthy male and female subjects.  


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This study will have up to 5 cohorts with a total of up to 40 subjects (8 subjects per 
cohort). An optional sixth dose cohort (maximum 48 subjects) will be considered after 
completion of 5 dose cohorts. 
 
The study will consist of a screening period (Day -28 to -2), check-in (Day -1), study drug 
administration (Day 1), treatment period (Days 1 to 7), clinic visit (Day 7), and a 
follow-up/end-of-study (EOS) visit (Day 14) for each cohort. 
 
In each cohort, 6 subjects will be randomly assigned to receive EC5026 and 2 subjects will 
receive placebo. Subjects will be enrolled in a manner to include approximately equal 
number of male and female subjects. The doses will be escalated in a stepwise fashion 
following acceptable safety and tolerability of the preceding dose(s). 
 
A blinded sentinel group of 2 subjects will be dosed at least 2 days before the remaining 6 
subjects will receive blinded doses of active study drug or placebo. If either of the sentinel 
subjects experiences a serious adverse event (SAE) or an adverse event (AE) that fulfills 
the stopping rule criteria as discussed in protocol Section 9.2.1.1, the dosing will be 
stopped for all subjects in the study pending a safety review; the remaining subjects will 
not initiate dosing until the safety incident is resolved. 
 
The planned dose levels are provided in Table 3-1. 
 
Table 3-1 
Planned Dosing Levels 
Cohort 
Dose 
Number of Subjects 
Receiving Study Drug 
Number of Subjects 
Receiving Placebo 
1A (Sentinel Group) 
0.5 mg 
1 
1 
1B 
0.5 mg 
5 
1 
2A (Sentinel Group) 
2 mg 
1 
1 
2B 
2 mg 
5 
1 
3A (Sentinel Group) 
8 mg 
1 
1 
3B 
8 mg 
5 
1 
4A (Sentinel Group) 
16 mg 
1 
1 
4B 
16 mg 
5 
1 
5A (Sentinel Group) 
32 mg 
1 
1 
5B 
32 mg 
5 
1 
6A (Sentinel Group)a 
48 mg 
1 
1 
6Ba 
48 mg 
5 
1 
a Optional sixth dose cohort 
 
Subjects will be confined to the clinical unit from check-in (Day -1) until discharge on 


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Day 5. A clinic visit will occur on Day 7, and a follow-up visit (EOS visit) will occur on 
Day 14. The duration of the study, including a 28-day screening period, is approximately 
43 days.  
 
Safety and PK data through Day 7, after completion of each cohort, will be reviewed by 
the safety review committee (SRC) in a blinded fashion before escalation to the next dose 
cohort. 
 
Safety, PK, and biomarker endpoints will be evaluated in the study. 
3.2. Study Endpoints 
3.2.1. Pharmacokinetic Endpoints 
 
The following PK parameters for EC5026 will be calculated as endpoints using standard 
noncompartmental methods: AUC0-t, AUC0-inf, AUC0-48, Cmax, Tmax, Kel, t1/2, CL/F, and 
Vz/F. The following urine PK parameters for EC5026 will be calculated as endpoints using 
standard noncompartmental methods: CLR, Ae, Ae(t1-t2), and Fe%. 
3.2.2. Safety Endpoints 
 
The safety and tolerability endpoints will include monitoring and recording of AEs, 
clinical laboratory test results (hematology, coagulation, serum chemistry, and urinalysis), 
vital sign measurements, 12-lead electrocardiogram (ECG) results, ECG telemetry, 
physical examination findings, and treatment emergent adverse events (TEAEs) compared 
with EC5026 blood levels. 
3.2.3. Pharmacodynamic Endpoints 
 
Exploratory biomarker assessments will be determined by EicOsis and reported separately 
from the clinical study report (CSR). 
4. General Statistical Considerations 
 
All data collected will be presented in data listings. Data from subjects excluded from an 
analysis population will be presented in the data listings but not included in the calculation 
of summary statistics. 
 
Unless otherwise indicated, outputs which are summarized by treatment will be 
summarized for each dose level for subjects on active study drug; subjects who receive 
placebo will be pooled into a single group. 
 


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For categorical variables, frequencies and percentages will be presented. Continuous 
variables will be summarized using descriptive statistics (number of subjects, mean, 
median, standard deviation [SD], minimum, and maximum). 
 
Unless specified otherwise, baseline will be defined as the last nonmissing assessment 
prior to the study drug administration. Unscheduled visits will be used in determining 
baseline. 
 
Unless otherwise indicated, outputs which are summarized by treatment will be 
summarized for each dose level for subjects on active study drug; subjects who receive 
placebo will be pooled into a single group. 
 
Study day will be calculated relative to the first dose date as follows: 
• If assessment date is on or after the dose of study drug administration, then 
Study Day = Assessment Date – Dose Date + 1 
• Otherwise, Study Day = Assessment Date – Dose Date 
4.1. Sample Size 
 
This study will enroll up to 48 subjects in 6 cohorts of 8 subjects each (the sixth cohort is 
optional). The sample size (N = 40 or N=48 with inclusion of the sixth cohort) for this 
study is based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size is considered sufficient to evaluate the objectives of the study. 
4.2. Analysis Populations 
 
The safety population will include all subjects who receive a single dose of study drug. 
 
The PK population will include subjects who receive a single dose of EC5026 and have 
sufficient concentration data to support accurate estimation of at least 1 PK parameter. 
Subjects who experience vomiting within 2 times the median Tmax after study drug dosing 
will be excluded from the PK analysis. 
 
The pharmacodynamic (PD) population will include subjects who receive a single dose of 
EC5026 and have a postdose PD measurement. Exploratory biomarker assessments will be 
determined by EicOsis and reported separately from the CSR and will not be described in 
this analysis plan. 


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5. Subject Disposition, Protocol Deviations, and Follow-up 
5.1. Disposition 
 
Subject disposition will be summarized by treatment and total for all randomized subjects. 
 
The number of subjects who are randomly assigned in the study and the number and 
percentage of subjects who complete the study will be presented. Frequency and 
percentage of subjects who withdraw or discontinue from the study, and the reason for 
withdrawal or discontinuation, will also be summarized. 
 
Subject disposition data, analysis populations, and randomization data will be presented in 
data listings. Subjects with screen failure will also be presented in a data listing. 
5.2. Protocol Deviations 
 
A protocol deviation is any change, divergence, or departure from the study design or 
procedures defined in the protocol. An important deviation (sometimes referred to as a 
major or significant deviation) is a subset of protocol deviations that leads to a subject 
being discontinued from the study, or significantly affects the subject’s rights, safety, or 
well-being or the completeness, accuracy, and reliability of the study data. An important 
deviation can include nonadherence to inclusion or exclusion criteria or nonadherence to 
Food and Drug Administration regulations or ICH E6(R2) guidelines. 
 
Protocol deviations will be documented by the clinical monitor throughout the course of 
monitoring visits. The Investigator will be notified in writing by the monitor of deviations. 
The Institutional Review Board should be notified of all protocol deviations, if appropriate, 
in a timely manner. 
 
Important protocol deviations will be summarized for all randomized subjects. 
 
All protocol deviations will be presented in a data listing, including the categorization of 
the deviation as important or not. Details of admission criteria deviations will be presented 
in a separate data listing. 
6. Demographics and Baseline Characteristics 
6.1. Demographics 
 
Demographic and baseline characteristics will be summarized by treatment and total for 
the safety population.  
 


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The demographic characteristics consist of age (years), sex, race, and ethnicity. The 
baseline characteristics consist of baseline weight (kg), height (cm), and body mass index 
(kg/m2). Percentages will be based on the total number of subjects in the safety population. 
 
Subject demographic and baseline characteristics will be presented in a data listing. 
6.1.1. Medical History 
 
Medical history will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA, version to be delineated in CSR). 
 
Medical history will be presented in a data listing for the safety population. 
7. Treatments, Medications, and Meals 
7.1. Prior and Concomitant Medications 
 
Information regarding prior medications taken by the subject within the 30 days before 
signing the informed consent form will be recorded in the subject’s electronic case report 
form (eCRF). 
 
Any concomitant medication deemed necessary for the welfare of the subject during the 
study may be given at the discretion of the investigator. If a concomitant medication is 
taken, except for those specified in the protocol, a joint decision will be made by the 
investigator and the sponsor to continue or discontinue the subject based on the time the 
medication was administered, its pharmacology and PK, and whether the use of the 
medication will compromise the safety of the subject or the interpretation of the data. The 
investigator is responsible for ensuring that details regarding the medication are adequately 
recorded in the eCRF. 
 
Prior and concomitant medications and therapies will be coded using the latest version of 
the World Health Organization Drug Dictionary. 
 
All prior and concomitant medications will be presented in a data listing for the safety 
population. 
7.2. Medical and Surgical Treatment Procedures 
 
All medical and surgical treatment procedures will be coded using MedDRA (version to be 
delineated in the CSR). All medical and surgical treatment procedures will be presented in 
a data listing for the safety population. 


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7.3. Study Drug Administration 
 
All doses of study drug will be administered in the clinical unit under direct observation of 
site personnel and recorded in the eCRF. Clinic personnel will confirm that the subject has 
received the entire dose of study drug. The date and time of study drug dosing will be 
recorded on the appropriate page of the eCRF. If a subject is not administered study drug, 
the reason for the missed dose will be recorded. 
 
All study drug administration data will be presented in a data listing. 
8. Pharmacokinetic Analysis 
8.1. Data Handling 
 
Plasma concentrations that are below the limit of quantification (BLQ) will be treated as 
zero for calculation of descriptive statistics. When all concentrations are BLQ for a 
timepoint, mean BLQ concentrations will be presented as BLQ, and the SD and CV will be 
reported as not applicable, otherwise the calculated mean will be presented. 
 
For PK parameter calculations, BLQ values will be treated as zero with the exception that a 
BLQ value between 2 quantifiable concentrations will be set as missing. If consecutive 
BLQ concentrations are followed by quantifiable concentrations in the terminal phase, 
those concentrations after BLQ concentrations will be treated as missing. 
 
Missing concentrations will be excluded from summaries and PK parameter calculations. 
8.2. Plasma Concentrations  
 
Blood samples for the determination of plasma concentrations of EC5026 will be collected 
on Day 1 at the following time points: predose (0), and at 1.25, 2.25, 4.25, 6.25, 8.25, 12.25, 
24, 36, 48, 72, 84, 96, and 108 hours postdose. Additional blood samples will be obtained 
on the mornings of Days 7 (168 hours) and 14 (336 hours) (or ET) postdose. 
 
Pharmacokinetic collections that have an actual sampling time that deviates from the 
nominal collection time by more than 10% will be flagged in the data listing, but the nominal 
sampling time will be used for summarization. 
 
EC5026 plasma concentration data will be summarized using descriptive statistics (number 
of subjects, number of nonmissing values, arithmetic mean, SD, CV, median, minimum, and 
maximum) by dose group and nominal sampling time. Individual and mean EC5026 plasma 
concentration versus time data will be plotted by dose group. For ease of presentation, mean 
plasma concentrations of EC5026 will be plotted by nominal time by dose group on both 
linear and semilogarithmic scales.  


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Plasma PK concentrations of EC5026 will be reported to the precision of the raw data in the 
data listing presentations; summary statistics for arithmetic mean, median, minimum, 
maximum, and SD will be reported to 3 significant figures; and CV% will be reported to 1 
decimal place. 
8.3. Urine Concentration 
 
Urine will be collected for analysis of EC5026 during the following time intervals: before 
dosing and 0 to 8 hours, 8 to 16 hours, 16 to 24 hours, 24 to 32 hours, 32 to 40 hours, and 
40 to 48 hours after administration of EC5026.  
 
Individual urine concentrations of EC5026 will be presented in a data listing by time interval 
and dose group. 
8.4. Plasma Pharmacokinetic Parameters 
 
The plasma concentration-time data for EC5026 will be analyzed by non-compartmental 
analysis using Phoenix® WinNonlin® (Certara USA, Inc., Princeton, NJ) Version 8.0 or 
higher. Actual sampling times will be used for the estimation of all plasma PK parameters. 
 
If data allow, the following PK parameters will be calculated: 
 
PK Parameter 
Definition 
Cmax  
Maximum (peak) plasma drug concentration 
Tmax  
Time to reach maximum (peak) plasma concentration following drug 
administration 
AUC0-t  
Area under the curve from time 0 to time t, where t is the time of the last 
quantifiable concentration calculated using the linear trapezoidal method. 
AUC0-inf  
Extrapolation of the area under the curve from time 0 to infinity, calculated 
as AUC0- inf = AUC0-t + Clast/λz, where Clast is the last quantifiable plasma 
drug concentration, calculated using the linear trapezoidal method 
AUC0-48 
Area under the curve from time 0 to time 48 hours postdose, calculated using 
the linear trapezoidal method. 
t1/2 
Terminal half-life, calculated as: t1/2= ln(2)/Kel 
CL/F 
Apparent total clearance of the drug from plasma after oral administration, 
calculated as: CL/F = Dose/AUC0- inf 
Vz/F 
Apparent volume of distribution  
 
In addition to the previously defined PK parameters, which will be listed and summarized, 
the following parameters will also be listed to document the selection of data points used to 
estimate t1/2 using non-compartmental procedures: 


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PK Parameter 
Definition 
%AUCextrap 
Percentage of the area extrapolated for calculation of AUC0-∞. 
Kel 
Apparent terminal elimination rate constant, where Kel is the magnitude of 
the slope of the linear regression of the log concentration versus time profile 
during the terminal phase. 
Number of 
points 
Number of data points used to estimate Kel; a minimum of 3 data points 
must be used, and Cmax must not be included. 
Kel lower 
Lower bound used for the estimation of Kel. 
Kel upper 
Upper bound used for the estimation of Kel. 
Rsq 
r2, the coefficient of determination (goodness of fit statistic); visual 
inspection of the terminal slope will be performed. In general, Kel may only 
be retained if r2 ≥ 0.80 
 
Plasma PK parameters for EC5026 will be presented in data listings and summarized by 
dose group using descriptive statistics (number of subjects, arithmetic mean, SD, CV%, 
median, minimum, and maximum) by dose group. Geometric means and geometric CV% 
will be reported for AUC0-t, AUC0-inf, AUC0-48, and Cmax.  Tmax will be summarized using 
the descriptive statistics median, minimum, and maximum only. 
 
Plasma PK parameters of EC5026 will be displayed to 3 significant figures in all data 
listings and summary tables, with exception of time variables (Tmax, Kel lower, and Kel 
upper) which will be displayed to 2 decimal places. 
8.5. Urine Pharmacokinetic Parameters 
 
The urine concentration-time data for EC5026 will be analyzed by non-compartmental 
analysis using Phoenix® WinNonlin® (Certara USA, Inc., Princeton, NJ) Version 8.0 or 
higher or SAS Version 9.4 or higher (SAS Institute Inc., Cary, North Carolina). 
 
If data allow, the following urine PK parameters will be calculated: 
PK Parameter 
Definition 
Aet1-t2 
Amount of drug excreted in urine (Ae) over each collection interval 
Ae 
Total amount of EC5026 excreted in urine 
Fe% t1-t2 
The fraction of the administered dose excreted in urine over each collection 
interval 
Fe% 
The fraction of the administered dose excreted in urine 
CLr 
Renal clearance 


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Urine PK parameters will be presented in data listings and summarized using descriptive 
statistics (n, arithmetic mean, SD, CV%, median, geometric mean, geometric CV%, 
minimum, and maximum) by dose group.  
 
Urine PK parameters will be displayed to 3 significant figures in all data listings and 
summary tables. 
8.6. Pharmacokinetic Statistical analysis 
 
Dose-proportionality for EC5026 will be evaluated for AUC0-t, AUC0-inf, AUC0-48, and 
Cmax. A power model will be fitted to describe the relationship between Y (AUC0-t, AUC0-
inf, AUC0-48, and Cmax) and X (dose) using the least-squares linear regression model, ln(Y) 
= ln(α) + β ln(X), which is the logarithmic form of Y = αXβ. 
 
The intercept of regression line, ln(α), and the slope of the regression line, β, will be 
presented along with the 90% confidence interval (CI) of the slope. Dose-proportionality 
will be concluded if the 90% CI of the slope β lies entirely within [1+ln(0.8)/ln(r), 
1+ln(1.25)/ln(r)], where r is a ratio that describes the dose range and is defined as the ratio 
of highest dose/lowest dose (Smith et al 2000). If dose proportionality is not observed, then 
the lowest dose followed by the highest dose in succession will be removed, and the model 
will be fit again after the removal of a dose until dose proportionality is achieved or less 
than 3 dose groups remain. 
 
The statistical analyses will be based on the PK population. 
9. Pharmacodynamics 
 
Exploratory PD assays may include biomarker assessments and plasma epoxide:diol ratios 
to evaluate potential target engagement of EC5026 versus the soluble epoxide hydrolase 
(sEH) enzyme. Exploratory PD assays will be reported separately and are not included in 
the statistical analysis plan. 
10. Safety Analysis 
 
All safety summaries and analyses will be conducted for the safety population. 
10.1. 
Adverse Events 
 
An AE is defined as any untoward medical occurrence in a patient or clinical investigation 
subject administered a pharmaceutical product regardless of its causal relationship to the 
study treatment.  
 


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A TEAE is defined as any event not present before exposure to study drug or any event 
already present that worsens in intensity or frequency after exposure. 
Only TEAEs will be included in summary tables. 
 
Adverse events will be coded by preferred term (PT) and system organ class (SOC) using 
MedDRA (version to be delineated in the CSR).  
 
A subject may have more than 1 AE for an SOC or PT. A subject with 2 or more AEs 
within the same level of summarization will be counted only once in that level. 
Percentages will be based upon the number of subjects in the safety population for each 
treatment group.  
 
All AEs will be presented in a data listing.  
10.1.1. Incidence of Adverse Events 
 
An overview of AEs will be presented by treatment and total, including number and 
percentage of subjects with any: 
 
• Treatment-emergent AE 
• Treatment-related TEAE 
• Moderate TEAE 
• Treatment-related moderate TEAE 
• Severe TEAE 
• Treatment-related severe TEAE 
• Serious TEAE 
• Treatment-related serious TEAE 
• Treatment-emergent AE leading to early discontinuation 
• Death 
 
All TEAEs will be presented in a summary table by treatment and total for each SOC and 
PT. Percentages will be calculated out of the number of subjects in the safety population.  
10.1.2. Relationship of Adverse Events to Study Drug 
 
The relationship or association of the study drug in causing or contributing to the AE will 
be characterized by the investigator as “Related” or “Not Related” as defined in protocol 
Section 9.3.5. 
 
All TEAEs will be presented in a summary table for each treatment group and total by 
relationship to study drug. If a subject has 2 or more TEAEs in the same SOC (or with the 
same PT) with a different relationship to study drug, then a “Related” event will be used 


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for that subject. If the relationship information is missing, the AE will be considered 
related in the summary but will be presented as missing in the data listings. 
10.1.3. Severity of Adverse Event 
 
All AEs (laboratory and clinical symptoms) will be graded for severity. The severity will 
be classified as mild, moderate, or severe using the following criteria: 
 
• Mild (Grade 1): Events that are transient and may require only minimal or no 
treatment or therapeutic intervention and do not interfere with the subject’s usual 
activities of daily living. 
• Moderate (Grade 2): Events that are alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, causing 
discomfort but poses no significant or permanent risk of harm to the subject. 
• Severe (Grade 3): Events interrupt usual activities of daily living, or significantly 
affects clinical status, or may require intensive therapeutic intervention. Severe 
events are usually incapacitating. 
• Potentially life-threatening Grade 4): An event that results in an emergency room 
visit or hospitalization. 
 
All TEAEs will be summarized for each treatment group and total by maximum severity. If 
the severity information is missing, the AE will be considered severe in the summary but 
will be presented as missing in the data listings. 
10.1.4. Serious Adverse Events 
 
An AE or suspected adverse reaction is considered an SAE/suspected unexpected serious 
adverse reaction if, in the view of either the investigator or sponsor, it results in any of the 
following outcomes: 
 
• Death 
• Life-threatening AE 
• Inpatient hospitalization or prolongation of existing hospitalization 
• Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions, or 
• Congenital anomaly or birth defect 
 
Important medical events that may not result in death, be life threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an 


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emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse. 
 
All SAEs will be presented in a data listing. 
10.1.5. Adverse Events Leading to Study Drug Discontinuation 
 
An AE where the answer to “What action was taken with study treatment?” is “Drug 
Withdrawn” will be considered an AE leading to study drug discontinuation. 
 
All AEs leading to study drug discontinuation will be presented in a data listing. 
10.2. 
Clinical Laboratory Evaluations 
 
Clinical laboratory testing will occur at Screening, Check-in and on Days 1, 2, 3, 4, 5, 7 
and 14/EOS. A complete list of assessments is provided in Appendix 2.  
 
Actual results and changes from baseline values for hematology, coagulation, serum 
chemistry, and urinalysis test results will be summarized by visit and treatment for subjects 
in the safety population. 
 
Shift from baseline in hematology, coagulation, serum chemistry, and urinalysis test results 
relative to the reference range will be summarized by visit and treatment using the 
frequency count and percentage of subjects in each category for the safety population. 
 
Serology, urine drug screen, and pregnancy test data will not be summarized but will be 
available in the data listings. 
 
All laboratory data will be presented in a data listing for the safety population. 
 
10.3. 
Vital Sign Measurements and Weight 
 
Vital signs will be measured at Screening, Check-in, on Day 1 within 45 minutes predose 
and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours following study drug dosing after the subject has 
been in the seated position for at least 5 minutes. On Days 2, 3, 4, 5, 7, and 14/EOS, 
evaluations will be performed in the morning. Vital signs will include blood pressure, 
pulse rate, respiratory rate, and body temperature. 
 
Actual values and changes from baseline for vital sign data will be summarized by visit 
and treatment for subjects in the safety population. Changes from baseline to each 
scheduled post-baseline visit will be presented. Only systolic and diastolic blood pressure, 
pulse rate, respiratory rate and temperature will be included in the summary tables. 


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All vital sign, height, and weight measurements will be presented in a data listing. 
10.4. 
Electrocardiograms 
10.4.1. 12-Lead Electrocardiogram 
 
Twelve-lead ECGs will be performed at Screening, Check-in, and on Day 1 within 
45 minutes prior to study drug dosing (predose) and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours 
following study drug dosing after the subject has been in the supine position for at least 
5 minutes. On Days 2, 3, 4, 5, 7, and 14/EOS, evaluations will be performed in the 
morning. A single repeat measurement is permitted at Screening for eligibility 
determination. Measurements of the following intervals will be reported: RR interval, 
PR interval, QRS width, QT interval, and QTcF. Assessments should include comments on 
whether the tracings are normal or abnormal; rhythm (if abnormal, specify the 
abnormality); presence of arrhythmia or conduction defects; morphology; any evidence of 
myocardial infarction; or ST-segment, T-Wave, and U-Wave abnormalities. 
 
Actual values and changes from baseline for numeric ECG data will be summarized by 
visit and treatment for subjects in the safety population. 
 
Shift from baseline in interpretation of ECG results will be summarized by visit and 
treatment using the frequency count and percentage of subjects in each category. 
 
All 12-lead ECG data will be presented in a data listing for the safety population. 
10.4.2. Electrocardiogram Telemetry 
 
The ECG telemetry will be evaluated at Check-in and on Days 1, 2, 3, and 4. All ECG 
telemetry data will be presented in a data listing for the safety population. 
10.5. 
Physical Examination 
 
A full physical examination will be performed at Screening, Check-in (Day -1), and on 
Days 1, 2, 3, 4, 5, 7, and 14 (or ET). A full physical examination will include skin, head, 
ears, eyes, nose, throat, neck, thyroid, respiratory, neurological, cardiovascular, abdomen, 
lymph nodes, and musculoskeletal system/extremities. 
 
Physical examination results will be presented in a data listing for the safety population. 


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11. Changes from the Planned Analysis 
 
Subjects will not be stratified to male and female as proposed in protocol Section 3, but 
they will be enrolled to include approximately equal numbers of male and female.  
12. Interim Analysis 
 
No formal interim analyses will be performed in this study. A blinded safety data review 
will be performed for each cohort before dose escalation is allowed. An interim safety 
analysis will be performed on a blinded basis within 1 week following the end of each 
dosing sequence (ie, within 5 business days or 7 calendar days after each SAD sequence is 
administered). Placebo data will be pooled from all completed cohorts to create the placebo 
control for each successive interim dose comparison. Any SAE and a higher-than-placebo 
incidence of nonserious AEs will be evaluated on an ad hoc basis and presented to the 
sponsor for consideration before subjects will be enrolled in the next dose cohort. 
 
The plasma concentration-time data and PK parameters for all subjects will be reviewed by 
the safety review committee (SRC). Pharmacokinetic stopping rules will be implemented 
based on the mean NOAEL of male and female animals from the most sensitive preclinical 
species considered for this study (28-day rat GLP safety study M386-18). Dose escalation 
will be stopped, and data will be reviewed by the SRC, if EC5026 Cmax is equal to 920 
ng/mL and/or if AUC0-48 is equal to 8400 ng•h/mL in any single subject within each cohort, 
or if the mean value is projected to reach either of these values in a subsequent cohort. 
13. References 
 
International Council for Harmonisation (ICH) E6 (R2) GCP: Integrated Addendum to 
ICH E6 (R1) Guidance for Industry, published in the Federal Register (83 Federal Register 
8882 [2018]) 
https://www.fda.gov/media/93884/download. 
 
Protocol EC5026-1-01: A Single-Center, Double-Blind, Placebo-Controlled, Phase 1A 
Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics 
of Sequential Dose Regimens of Oral EC5026 in Healthy Male and Female Subjects, 
Version 2.0, 15 October 2019.


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14. Appendices 
Appendix 1 Schedule of Events 


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Phase Screening 
Check-in 
Treatment Period 
FU/EOS/ET 
ProcedureError! 
Reference source not found. 
Day 
–28 to –2 
–1 
1 
2 
3 
4 
5 
7 
14 (±2) 
Admission to clinic 
 
X 
 
 
 
 
 
 
 
Randomization 
 
 
X 
 
 
 
 
 
 
Discharge from clinic 
 
 
 
 
 
 
X 
 
 
Outpatient visit(b) 
 
 
 
 
 
 
 
X 
X 
Informed consent 
X 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical and medication history 
X 
X 
 
 
 
 
 
 
 
Physical examination(c)  
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height, weight, and BMI(d) 
X 
X 
X 
 
 
 
 
 
 
Vital sign measurements(e) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG(f) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ECG telemetry(f) 
 
X 
X 
X 
X 
X 
 
 
 
Clinical laboratory testing(g) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Viral serology(h) 
X 
 
 
 
 
 
 
 
 
Urine drug and alcohol screen(i) 
X 
X 
 
 
 
 
 
 
 
Serum pregnancy test(j) 
X 
X 
 
 
 
 
 
 
X 
Serum FSH(k) 
X 
 
 
 
 
 
 
 
 
EC5026 administration(l) 
 
 
X 
 
 
 
 
 
 
PK blood sample collection(m) 
 
 
X 
X 
X 
X 
X 
X 
X 
Blood samples for external biomarker assessments(n) 
 
 
X 
X 
X 
X 
X 
X 
X 
Urine volume, electrolytes(o) 
 
X 
X 
X 
X 
X 
 
 
 
Urine samples for EC5026(p) 
 
 
X 
X 
 
 
 
 
 
Fasting period(q) 
 
X 
X 
 
 
 
 
 
 
Non-fasting period(r) 
 
 
 
X 
X 
X 
X 
X 
 
AEs(s) 
 
X 
X 
X 
X 
X 
X 
X 
X 
Prior/concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: AE, adverse event; BMI, body mass index; ECG, electrocardiogram; EOS, end of study; ET, early termination; FSH, follicle-
stimulating hormone; FU, follow-up; PK, pharmacokinetic; QTcF, QT interval corrected for heart rate using Fridericia’s formula. 
Notes: 
(a) When procedures overlap or occur at the same time point, all blood draws should follow vital signs or ECGs, and PK sampling should be timed 
to occur last and as close to the scheduled time window as possible. 
(b) Follow-up/EOS visit will occur on Day 14 (± 2 days) or 2 days after ET. 


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(c) A full physical examination will be performed at Screening, Check-in (Day -1), and on Days 1, 2, 3, 4, 5, 7, and 14 (or ET). A full physical 
examination will include skin, head, ears, eyes, nose, throat, neck, thyroid, respiratory, neurological, cardiovascular, abdomen, lymph nodes, and 
musculoskeletal system/extremities. 
(d) Height and weight will be measured, and BMI calculated at Screening only. Only weight will be measured on Days –1 and 1. 
(e) Vital signs will be measured at Screening, on Day –1, and on Day 1 within 45 minutes prior to study drug dosing (predose) and at 0.5, 1, 2, 3, 4, 
6, 8, and 12 hours following study drug dosing after the subject has been in the seated position for at least 5 minutes. On other days, evaluations will 
be performed in the morning. Vital signs will include blood pressure, pulse rate, respiratory rate, and body temperature. 
(f) Twelve-lead ECGs will be performed at Screening, on Day –1, and on Day 1 within 45 minutes prior to study drug dosing (predose) and at 0.5, 1, 
2, 3, 4, 6, 8, and 12 hours following study drug dosing after the subject has been in the supine position for at least 5 minutes. On other days, 
evaluations will be performed in the morning. A single repeat measurement is permitted at Screening for eligibility determination. Measurements of 
the following intervals will be reported: RR interval, PR interval, QRS width, QT interval, and QTcF. Assessments should include comments on 
whether the tracings are normal or abnormal; rhythm (if abnormal, specify the abnormality); presence of arrhythmia or conduction defects; 
morphology; any evidence of myocardial infarction; or ST-segment, T-Wave, and U-Wave abnormalities. 
(g) Clinical laboratory testing will occur at Screening, on Day –1, and on Days 1, 2, 3, 4, 5, 7, and 14 (or ET). A complete list of assessments is 
provided in Section 6.3.2. Blood and urine samples will be collected under fasted conditions and prepared per the clinic’s standard procedures. 
(h) Viral serology testing (Screening only) will include hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus 
types 1 and 2 antibodies. 
(i) Urine drug and alcohol screen will occur at Screening and on Day –1 per the clinic’s standard procedures. 
(j) A serum pregnancy test will be performed at Screening, on Day –1, and Day 14 (or ET) in premenopausal women of childbearing potential or 
women who are surgically sterile. 
(k) A serum FSH test will be performed at Screening to confirm postmenopausal status in older women. 
(l) The time of study drug dosing will be called “0” hour in each period and is denoted with grey shading. Study drug will be administered with 
240 mL of room temperature water. Subjects will maintain an upright (ie, seated or standing) position for at least 4 hours after dosing. 
(m) Blood samples for PK analysis of EC5026 in plasma will be collected prior to study drug dosing and at 1.25, 2.25, 4.25, 6.25, 8.25, 12.25, 24, 
36, 48, 72, 84, 96, and 108 hours after study drug dosing and after vital signs have been recorded. Additional blood samples will be obtained on the 
mornings of Days 7 and 14 (or ET). Postdose PK blood samples should be collected within ±5 minutes of the scheduled collection time for the first 
8.25 hours, then within ±15 minutes of the scheduled collection time up to 24 hours, and within ±30 minutes of the scheduled collection time up to 
clinic discharge on Day 5. Pharmacokinetic samples may be collected at any time during the day on Days 7 and 14. The actual time of blood 
sampling will be recorded in the source documents and electronic case report form.  
(n) Blood samples (0.1 mL frozen plasma from each PK sample) for external exploratory biomarker assessments will be collected, stored, and 
shipped in bulk to the sponsor for poststudy biomarker measurements.  
(o) Total voided urine will be combined and collected over the following intervals: –16 to –8, –8 to 0, 0 to 8, 8 to 16, 16 to 24, 24 to 32, 32 to 40, 
40 to 48, 48 to 56, 56 to 64, and 64 to 72 hours. Urinalysis on pooled samples includes sodium, potassium, calcium, magnesium, chloride, phosphate, 
and bicarbonate.  
(p) Urine samples for PK analysis of EC5026 will be collected before study drug administration (predose) and collected and pooled over the 
following intervals: 0 to 8, 8 to 16, 16 to 24, 24 to 32, 32 to 40, and 40 to 48 hours after study drug administration. Additional aliquots from each 
period will be collected for exploratory urinary metabolite profiling; samples will be collected, stored, and shipped in bulk to the sponsor for 
poststudy evaluation. 


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(q) During fasting periods, subjects should have nothing to eat or drink, except water, from 10 hours prior to EC5026 dosing until 4 hours after 
dosing. Water is permitted as desired except for the period 1 hour before and 1 hour after administration of study drug (other than as permitted for 
study drug dosing). 
(r) During nonfasting periods, subjects should receive standardized meals per the clinic’s standard procedures that are scheduled at approximately 
the same time each day. 
(s) Adverse events will be assessed from the time of EC5026 dosing until Day 14 (or ET) and should be followed until they are resolved, stable, or 
judged by the investigator to be not clinically significant. 
 


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Appendix 2 CLINICAL LABORATORY ASSESSMENTS 
 
The following clinical laboratory assessments will be performed: 
 
Hematology 
Complete blood count including red blood cell count, 
hemoglobin, hematocrit, mean corpuscular hemoglobin, 
mean corpuscular volume, mean corpuscular hemoglobin 
concentration, white blood cell count, differential white 
blood cell count, and platelet count 
Coagulation 
Activated partial thromboplastin time, prothrombin time, 
and international normalized ratio 
Serum chemistry 
Albumin, ALP, ALT, AST, bicarbonate, total bilirubin, 
blood urea nitrogen, calcium, chloride, total cholesterol, 
creatinine, gamma-glutamyltransferase, glucose, lactate 
dehydrogenase, phosphorus, potassium, total protein, 
sodium, magnesium, total protein, CPK, and uric acid 
Urinalysis 
Protein, glucose, blood, microalbumin, and microscopy 
under reflex only 
Serology 
Hepatitis B surface antigen, hepatitis C virus antibody, and 
human immunodeficiency virus antibody types 1 and 2 
(Screening only) 
Urine drug screen 
Amphetamines, barbiturates, benzodiazepines, 
cannabinoids, cocaine metabolites, cotinine, 
methamphetamines, methylenedioxymethamphetamine, and 
opioids including heroin, codeine, and oxycodone) and 
alcohol screen 
Pregnancy test 
(female subjects only) 
Serum follicle-stimulating hormone test for 
postmenopausal females and serum pregnancy test for 
premenopausal females 
ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase;  
CPK = creatine phosphokinase.