A Phase 2b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™ in Healthy Subjects and Patients With Varying Degrees of Renal Impairment
Conditions: Kidney Diseases, Renal Insufficiency, Chronic, Acute Kidney Injury, Urologic Diseases, Renal Insufficiency
Sponsor: FAST BioMedical

Clinical Study Protocol 
 
A Phase 2b Open-Label Study to Evaluate the Safety, Tolerability, 
Pharmacokinetics, and Pharmacodynamics of FAST PV and 
mGFR Technology™ in Healthy Subjects and Patients with Varying Degrees 
of Renal Impairment 
 
Protocol Number: 36770001 
 
Final Version 1.1 
Date: 17July 2017 
 
Sponsor: 
FAST BioMedical 
9650 Commerce Drive 
Suite 521 
Carmel, IN 46032, USA 
Telephone: (866)700-7310 ext.701 
 
Contract Research Organization: 
ICON Clinical Research, LLC 
820 West Diamond Avenue, Suite 100 
Gaithersburg, MD 20878, USA 
Telephone: (301) 944-6800 
Fax: (215) 699-6288 
 
Confidentiality Statement 
This document and the information contained herein or attached hereto ("Confidential Material") are confidential 
and proprietary to FAST BioMedical. This Confidential Material should be viewed only by those individuals or 
companies that have been given prior authorization to do so by FAST BioMedical ("Authorized Users"). This 
Confidential Material should not be made available in any form to any person or company, other than the 
Authorized Users and their respective employees or associates on a need-to-know basis, without the prior written 
consent from FAST BioMedical.

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 2 of 81 
TABLE OF CONTENTS 
1 
SIGNATURES .......................................................................................................... 6 
2 
SYNOPSIS................................................................................................................. 9 
3 
INTRODUCTION AND BACKGROUND ............................................................ 37 
3.1 
Introduction ..................................................................................................... 37 
3.2 
Investigational Device Background ................................................................. 37 
3.3 
Investigational Product Background............................................................... 38 
3.4 
Summary of Findings to Date .......................................................................... 38 
3.4.1 
Nonclinical Studies ............................................................................................ 38 
3.4.2 
First-in-Human Study......................................................................................... 40 
3.4.3 
Phase 2a Study at University of Alabama at Birmingham ................................... 41 
3.5 
Iohexol Background ......................................................................................... 43 
3.6 
Study Rationale ................................................................................................ 45 
3.6.1 
Rationale for Dose Selection .............................................................................. 45 
3.6.2 
Rationale for Study Design ................................................................................ 45 
3.7 
Hypotheses ........................................................................................................ 46 
4 
OBJECTIVES ......................................................................................................... 47 
4.1 
Primary Objectives .......................................................................................... 47 
4.2 
Secondary Objectives ....................................................................................... 47 
5 
STUDY DESIGN..................................................................................................... 48 
5.1 
Study Design and Overview ............................................................................. 48 
5.1.1 
Interim Safety Data Review ............................................................................... 50 
5.1.2 
Duration of Study ............................................................................................... 50 
5.1.3 
Definition of Study Completion ......................................................................... 50 
5.1.4 
End of Study ...................................................................................................... 50 
6 
SELECTION AND WITHDRAWAL OF SUBJECTS ......................................... 51 
6.1 
Inclusion Criteria ............................................................................................. 51 
6.2 
Exclusion Criteria ............................................................................................ 52 
6.3 
Subject Withdrawal ......................................................................................... 54 
6.4 
Early Termination of Study ............................................................................. 55 
6.4.1 
Cohort Stopping Criteria .................................................................................... 55 
6.4.2 
Individual Subject Stopping Criteria................................................................... 55 
7 
TREATMENT OF SUBJECTS .............................................................................. 56 
7.1 
Identity of Investigational Product .................................................................. 56 
7.2 
Identity of Comparator Products .................................................................... 56 
7.3 
Treatments Administered ................................................................................ 56 
7.4 
Method of Assigning Subjects to Treatment Groups...................................... 57 
7.5 
Measurements of Treatment Compliance ....................................................... 57 
7.6 
Investigational Product Storage, Accountability, and Retention ................... 57 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
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7.6.1 
Storage Conditions ............................................................................................. 57 
7.6.2 
Drug Preparation ................................................................................................ 57 
7.7 
Packaging and Labeling ................................................................................... 57 
7.7.1 
Study Drug......................................................................................................... 57 
7.7.2 
Blinding of Treatment Assignment ..................................................................... 58 
7.8 
Concomitant Medications and Other Restrictions ......................................... 58 
7.8.1 
Concomitant Medications................................................................................... 58 
7.8.2 
Other Restrictions .............................................................................................. 58 
8 
STUDY ASSESSMENTS AND PROCEDURES ................................................... 59 
8.1 
Medical and Surgical History .......................................................................... 59 
8.2 
Demographic Characteristics .......................................................................... 59 
8.3 
Physical Measurements .................................................................................... 59 
8.4 
Pharmacokinetic Assessments ......................................................................... 59 
8.4.1 
Drug Concentration Measurements .................................................................... 59 
8.4.2 
Pharmacokinetic Parameters .............................................................................. 59 
8.5 
Pharmacodynamic Assessments ...................................................................... 61 
8.5.1 
Pharmacodynamic Parameters ............................................................................ 61 
8.5.1.1 
Plasma Volume .................................................................................................. 61 
8.5.1.2 
Glomerular Filtration Rate ................................................................................. 61 
8.6 
Safety Assessments ........................................................................................... 63 
8.6.1 
Adverse Events .................................................................................................. 63 
8.6.2 
Clinical Laboratory Tests ................................................................................... 63 
8.6.3 
Other Tests......................................................................................................... 64 
8.6.4 
Vital Signs ......................................................................................................... 64 
8.6.5 
Pulse Oximetry .................................................................................................. 64 
8.6.6 
Physical Examination ......................................................................................... 64 
8.6.7 
Electrocardiograms ............................................................................................ 65 
8.6.8 
Appropriateness of Safety Assessments .............................................................. 65 
9 
ADVERSE EVENTS ............................................................................................... 66 
9.1 
Recording Adverse Events ............................................................................... 66 
9.2 
Assessment of Adverse Events ......................................................................... 66 
9.2.1 
Serious Adverse Events ...................................................................................... 67 
9.2.2 
Intensity ............................................................................................................. 67 
9.2.3 
Relationship to Study Drug ................................................................................ 68 
9.2.4 
Significant Adverse Events ................................................................................ 68 
9.3 
Discontinuation due to Adverse Events ........................................................... 68 
9.4 
Reporting Serious Adverse Events .................................................................. 68 
9.5 
Pregnancy ......................................................................................................... 69 
9.6 
Drug-induced Liver Injury .............................................................................. 69 
10 
STATISTICAL CONSIDERATIONS ................................................................... 71 
10.1 
Sample Size Calculation ................................................................................... 71 
10.2 
Analysis Populations ........................................................................................ 71 
10.3 
Endpoints ......................................................................................................... 72 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
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10.3.1 
Primary Endpoints ............................................................................................. 72 
10.3.1.1 Safety................................................................................................................. 72 
10.3.1.2 Pharmcokinetics ................................................................................................. 72 
10.3.2 
Secondary Endpoints .......................................................................................... 72 
10.3.2.1 Pharmacodynamic .............................................................................................. 72 
10.4 
Pharmacokinetic Statistical Analysis .............................................................. 73 
10.5 
Pharmacodynamic Statistical Analysis ........................................................... 73 
10.5.1 
Plasma Volume .................................................................................................. 73 
10.5.2 
Glomerular Filtration Rate ................................................................................. 73 
10.6 
Safety Analysis ................................................................................................. 73 
11 
ACCESS TO SOURCE DATA/DOCUMENTS ..................................................... 74 
12 
QUALITY CONTROL AND QUALITY ASSURANCE ...................................... 75 
12.1 
Conduct of Study.............................................................................................. 75 
12.1.1 
Protocol Deviations ............................................................................................ 75 
12.2 
Protocol Amendments ...................................................................................... 76 
12.3 
Monitoring of Study ......................................................................................... 76 
13 
ETHICS ................................................................................................................... 77 
13.1 
Institutional Review Board/Independent Ethics Committee Approval ......... 77 
13.1.1 
Ethics Review Prior to Study.............................................................................. 77 
13.1.2 
Ethics Review of other Documents..................................................................... 77 
13.2 
Written Informed Consent .............................................................................. 77 
14 
DATA HANDLING AND RECORD KEEPING ................................................... 78 
14.1 
Data Reporting and Case Report Forms ......................................................... 78 
14.1.1 
Case Report Forms ............................................................................................. 78 
14.1.2 
Laboratory Data ................................................................................................. 78 
14.1.3 
Retention of Source Documents ......................................................................... 78 
14.2 
Retention of Essential Documents ................................................................... 78 
15 
ADMINISTRATIVE INFORMATION ................................................................. 79 
15.1 
Financing and Insurance ................................................................................. 79 
15.2 
Publication Policy ............................................................................................. 79 
16 
REFERENCES ....................................................................................................... 80 
APPENDIX A 
PREPARATION OF FAST VISIBLE FLUORESCENT 
INJECTATE™ ....................................................................................................... 81 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
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July 17th, 2017 Version 1.1 Monday, July 24, 2017 
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LIST OF TABLES 
Table 2.1 
Schedule of Assessments and Procedures – Cohort 1 (Single-dose 
Administration of VFI) ...................................................................................... 15 
Table 2.2 
Schedule of Assessments and Procedures – Cohort 2 (Repeat-dose 
Administration of VFI) ...................................................................................... 18 
Table 2.3.1 
UAB Schedule of Assessments and Procedures – Cohorts 3 and 4 
(Single-dose Administration of VFI) .................................................................. 21 
Table 2.3.2 
ICON Schedule of Assessments and Procedures – Cohorts 3  
(Single-dose Administration of VFI) .................................................................. 25 
Table 2.4 
Pharmacokinetic and Pharmacodynamic Sampling Schedule – 
Cohort 1 (Single-dose Administration of VFI).................................................... 29 
Table 2.5 
Pharmacokinetic and Pharmacodynamic Sampling Schedule - 
Cohort 2 (Repeat-dose Administration of VFI) ................................................... 30 
Table 2.6 
Pharmacokinetic and Pharmacodynamic Sampling Schedule – 
Cohort 3 and 4 (Single-dose Administration of VFI) .......................................... 31 
Table 3.2 
Phase II Patients by Cohort ................................................................................ 41 
Table 5.1 
Planned Dose Cohorts ........................................................................................ 49 
Table 6.1 
Individual Stopping Criteria ............................................................................... 55 
Table 7.1 
Investigational Product ....................................................................................... 56 
Table 7.2 
Comparator Products .......................................................................................... 56 
Table 8.1 
Chronic Kidney Disease Epidemiology Collaboration Equation for 
Estimating Glomerular Filtration Rate Expressed for Specified 
Race, Sex, and Serum Creatinine (mg/dL) .......................................................... 62 
Table 8.2 
Chronic Kidney Disease Epidemiology Collaboration Equation for 
Estimating Glomerular Filtration Rate Expressed for Specified 
Race, Sex, and Serum Creatinine (μmol/L) ........................................................ 62 
Table 8.3 
Clinical Laboratory Tests ................................................................................... 63 
 
LIST OF FIGURES 
Figure 3.1 
The results of a FAST Plasma Volume Measurement Volume 
Challenge Test in a healthy dog model. .............................................................. 40 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 6 of 81 
1 
SIGNATURES 
Protocol Number: 36770001 
Protocol Title: A Phase 2b Open-Label Study to Evaluate the Safety, Tolerability, 
Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™ in 
Healthy Subjects and Patients with Varying Degrees of Renal Impairment 
Investigator Signature 
I agree to conduct the aforementioned study according to the terms and conditions of the 
protocol, Good Clinical Practice (GCP) guidelines, and all other applicable local and regulatory 
requirements. All information pertaining to the study will be treated in a confidential manner. 
 
 
 
 
 
Emmanuel DeNoia, MD 
 
Date 
 
 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 7 of 81 
 
Investigator Signature 
I agree to conduct the aforementioned study according to the terms and conditions of the 
protocol, Good Clinical Practice (GCP) guidelines, and all other applicable local and regulatory 
requirements. All information pertaining to the study will be treated in a confidential manner. 
 
 
 
 
 
Dana V. Rizk, MD 
 
Date 
 
 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 8 of 81 
 
FAST BioMedical Signatures 
This clinical study protocol has been reviewed and approved by FAST BioMedical. 
 
 
 
 
 
James Strickland 
President 
 
Date 
 
 
 
 
 
Bruce Molitoris, MD 
Medical Director 
 
Date 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 9 of 81 
2 
SYNOPSIS 
Protocol Title: 
A Phase 2b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, 
and Pharmacodynamics of FAST PV and mGFR Technology™ in Healthy Subjects and 
Patients with Varying Degrees of Renal Impairment 
 
Study Phase: 
2b 
 
Indication: 
Quantitative determination of plasma volume (PV) and measured glomerular filtration 
rate (mGFR) 
 
Investigators and 
Clinical Research 
Units: 
Cohorts 1 and 2: 
Emanuel DeNoia, MD 
ICON Early Phase Services, LLC 
 
Cohort 3: 
Dana V. Rizk, MD 
University of Alabama Birmingham 
Emanuel DeNoia, MD 
ICON Early Phase Services, LLC 
 
Cohort 4: 
Dana V. Rizk, MD 
University of Alabama Birmingham 
 
Objectives: 
Primary: 
x 
To assess the safety and tolerability of visible fluorescent injectate (VFI)™ 
(employing the FAST PV and mGFR Technology™) compared to Iohexol 
(employing Iohexol clearance methods) in healthy subjects and patients with 
impaired renal function 
x 
To evaluate the pharmacokinetics (PK) of FD001 and FD003 in healthy subjects 
and patients with impaired renal function 
x 
To evaluate the PK of FD001 and FD003 in healthy subjects receiving 2 doses of 
VFI separated by 24 hours to evaluate the reproducibility of the FAST mGFR 
Technology. 
 
Secondary: 
x 
To evaluate the relationship between FAST PV and mGFR Technology and 
standard clinical formulaic estimates of PV in healthy subjects 
x 
To evaluate and compare glomerular filtration rates (GFRs) determined from 
FAST PV and mGFR Technology and Iohexol clearance in healthy subjects and 
patients with impaired renal function 
x 
To evaluate the GFR measurements in relation to current clinical standards in 
healthy subjects and patients with impaired renal function 
x 
To evaluate the FAST PV Technology’s ability to measure changes in vascular 
plasma volume resulting from a fluid challenge after the baseline PV measurement 
 
Hypotheses: 
This is an exploratory pilot investigation without any formal statistical hypotheses. All 
results will only be interpreted descriptively. Correlation analysis and Bland-Altman 
plots will be used to compare the FAST mGFR with Iohexol clearance. 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
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Endpoints: 
Primary: 
Safety: 
x 
Adverse events (AEs) and serious AEs (SAEs) 
x 
Clinical laboratory tests, physical examination findings, 12-lead 
electrocardiograms (ECGs), and vital signs including pulse oximetry 
 
 
 
Pharmacokinetics: 
x 
Maximum observed plasma concentration (Cmax) 
x 
Time that Cmax was observed (tmax) 
x 
Area under the plasma concentration-time curve (AUC) from time 0 to 12 hours 
(AUC0-12: FD001 only) 
x 
AUC from time 0 to the time of the last quantifiable concentration (AUClast) 
x 
AUC from time 0 extrapolated to infinity (AUCinf) 
x 
Terminal elimination half-life (t½) 
x 
Terminal eliminDWLRQUDWHFRQVWDQWȜz) 
x 
Total body clearance (CL) 
x 
Renal clearance from time 0 to 2 hours (CLr0-2; FD001 only) 
x 
Renal clearance from time 2 to 12 hours (CLr2-12; FD001 only) 
x 
Renal clearance from time 0 to 12 hours (CLr0 12; FD001 only) 
x 
Volume of distribution during the terminal phase (Vz) 
x 
Volume of distribution at steady state (Vss) 
x 
Amount of FD001 excreted unchanged in the urine from time 0 to 2 hour (Ae0-2) 
x 
Amount of FD001 excreted unchanged in the urine from time 2 to 12 hour (Ae2-12) 
x 
Amount of FD001 excreted unchanged in the urine from time 0 to 12 hour (Ae0-12) 
 
Secondary: 
Pharmacodynamic: 
x 
PV as assessed by FAST PV and mGFR Technology 
x 
PV as assessed by Nadler’s formula 
x 
Assess changes in PV after fluid challenge 
x 
Assess repeatability of GFR measurements over 24 hours 
x 
mGFR as assessed by FAST VFI and Iohexol clearance methods 
x 
Estimated GFR (eGFR) (calculated by the Modification of Diet in Renal Disease 
[MDRD], Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 
Creatinine, and Cockcroft-Gault equations) 
 
Study Design: 
This is a Phase 2b, prospective, open-label study designed to evaluate the safety, 
tolerability, PK, and pharmacodynamics (PD) of FAST PV and mGFR Technology in 
healthy subjects and patients with varying degrees of renal impairment. 
 
For Cohorts 1 and 2, administration of the study drug will occur within 21 days of 
screening. Eligible subjects will be admitted to the clinical research unit (CRU) on Day 
-1, at which time assessments will be performed, and results from both screening and 
Day -1 (inclusion/exclusion criteria, body weight, height [screening only], body mass 
index [BMI], medical and surgical history, physical examination, vital signs and pulse 
oximetry, 12-lead ECG, clinical laboratory tests, renal function assessment, follicle-
stimulating hormone [FSH; screening only] and pregnancy test [females only], urine 
drugs of abuse, and serum alcohol screen) will be reviewed to confirm eligibility. 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
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July 17th, 2017 Version 1.1 Monday, July 24, 2017 
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Study Design: 
continued 
For Cohorts 3 and 4, administration of the study drug will occur within 21 days of 
screening.  
 
Eligible patients enrolled at UAB will be admitted to the CRU on Day 1, at which time 
assessments will be performed and results from both screening and predose 
administration testing (inclusion/exclusion criteria, body weight, height [screening 
only], BMI, medical and surgical history, physical examination, vital signs and pulse 
oximetry, 12-lead ECG, clinical laboratory tests, renal function assessment, FSH 
[screening only] and pregnancy test [females only], urine drugs of abuse, and serum 
alcohol screen) will be reviewed to confirm eligibility. 
 
Eligible patients enrolled into Cohort 3 at ICON Early Phase Services, LLC will be 
admitted to the CRU on Day -1 and will remain resident in the CRU through discharge 
on Day 2. Eligible subjects will be admitted to the clinical research unit (CRU) on Day -
1, at which time assessments will be performed, and results from both screening and 
Day -1 (inclusion/exclusion criteria, body weight, height [screening only], body mass 
index [BMI], medical and surgical history, physical examination, vital signs and pulse 
oximetry, 12-lead ECG, clinical laboratory tests, renal function assessment, follicle-
stimulating hormone [FSH; screening only] and pregnancy test [females only], urine 
drugs of abuse, and serum alcohol screen) will be reviewed to confirm eligibility. 
 
The planned dose cohorts are presented in the table below: 
*Subjects in Cohort 1 will receive a volume challenge 
 
Cohort 1: 
Eligible subjects NJLQZHLJKWwill receive a single dose of VFI followed 
130 minutes later by a 350 mL infusion of 5% albumin over 30 minutes on Day 1. 
Eligible subjects < 50 kg in weight will receive a single dose of VFI followed 
130 minutes later by a maximum infusion of 5% albumin of 7 mL/kg over 30 minutes 
on Day 1. Subjects will remain resident in the CRU for at least 24 hours after VFI 
administration for safety assessment. Subjects will return to the CRU for an 
end-of-study (EOS) visit on Day 21 (± 1 day). 
 
Cohort 2: 
Eligible subjects will receive a dose of VFI followed 160 minutes later by a single dose 
of Iohexol on Day 1 and a second dose of VFI 24 hours (on Day 2) after the initial dose 
of VFI. Subjects will remain resident in the CRU for at least 24 hours after the second 
VFI administration for safety, PK, and PD assessments. Subjects will return to the CRU 
for follow-up visits on Days 5 (± 1 day), 9 (± 1 day), and 16 (± 1 day), and an EOS visit 
on Day 22 (± 1 day). 
 
Cohorts 3 and 4: 
Eligible patients will receive a single dose of VFI followed 160 minutes later by a single 
dose of Iohexol on Day 1.  
 
Cohort 
eGFR 
VFI Dose 
Number 
of Doses 
Comparator 
Dose 
Number 
of Doses 
Number of 
Subjects 
1* 
 60 mL/min/1.73 m2 
47 mg/3 mL 
1 
--- 
--- 
Up to 8 
2 
 60 mL/min/1.73 m2 
47 mg/3 mL 
2 
Iohexol 5 mL 
1 
Up to 8 
3 
DQG mL/min/1.73 m2 
47 mg/3 mL 
1 
Iohexol 5 mL 
1 
Up to 8 
4 
DQG < 30 mL/min/1.73 m2 
47 mg/3 mL 
1 
Iohexol 5 mL 
1 
Up to 8 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 12 of 81 
Study Design: 
continued 
Patients enrolled into Cohort 3 at ICON Early Phase Services will remain resident in the 
CRU for at least 24 hours after VFI administration for safety, PK, and PD assessments. 
Patients will return to the CRU for follow-up visits on Days 4 (± 1 day), 8 (± 1 day), and 
15 (± 1 day), and an EOS visit on Day 21 (± 1 day). 
 
Patients enrolled into Cohorts 3 or 4 at UAB will remain in the CRU through the 12-
hour sample collection after VFI administration for safety, PK, and PD assessments. 
Patients will stay at a local hotel near the CRU and will return to the CRU on Day 2 for 
24-hour sample collection. Patients will return to the CRU for follow-up visits on 
Days 4 (± 1 day), 8 (± 1 day), and 15 (± 1 day), and an EOS visit on Day 21 (± 1 day). 
 
Subject Selection 
Criteria: 
Males and females (women must be post-menopausal or be using a medically 
acceptable form of birth control) 18 to 75 years of age, inclusive, with a body weight of 
at least 40 kg will be enrolled in the study. Reproductively active men must agree to 
either practice abstinence or utilize adequate contraception. Healthy subjects in 
Cohorts 1 and 2 must have an eGFR calculated using the CKD-EPI Creatinine Equation 
(2009)  60 mL/min/1.73 m2 and a BMI of 18.0 to 40.0 kg/m2, inclusive. Patients with 
impaired renal function in Cohort 3 must have an eGFR  30 and < 60 mL/min/1.73 m2 
and patients with impaired renal function in Cohort 4 must have an eGFR 15 and < 
30 mL/min/1.73 m2. Patients in Cohorts 3 and 4 must have a BMI of 18.0 to 40.0 kg/m2, 
inclusive. 
 
Investigational 
Product, Dose, and 
Route of 
Administration: 
 
VFI, 47 mg/3 mL, bolus injection (35mg of FD001 and 12mg of FD003) 
Comparator Products, 
Dose, and Route of 
Administration: 
 
Omnipaque™ 300 (Iohexol), 5 mL, bolus injection (Cohorts 2 through 4) 
 
Criteria for Evaluation: 
Safety:  
Adverse events (AEs) will be collected and evaluated as they occur throughout the 
study. Safety assessments, including physical examinations, vital signs including pulse 
oximetry assessments, 12-lead ECGs, and clinical laboratory tests, will be performed at 
specified time points. 
Pharmacokinetics: Pharmacokinetic samples for plasma FD001 and FD003 
concentration determination in Cohort 1 will be collected predose and 15, 30, 60, 120, 
165, 195, 205, 310, 370, and 480 minutes and 12 and 24 hours post VFI dose. 
Pharmacokinetic samples for plasma FD001 and FD003 concentration determination in 
Cohort 2 will be collected predose and 15, 30, 60, 120, 170, 310, 370, and 480 minutes, 
12 and 24 hours post VFI dose on Days 1 and 2, and on Days 5 (± 1 day), 9 (± 1 day), 
16 (± 1 day), and 22 (± 1 day). Pharmacokinetic samples for plasma FD001 and FD003 
concentration determination in Cohorts 3 and 4 will be collected predose and 15, 30, 60, 
120, 170, 310, 370, and 480 minutes, 12, 24, and 32 hours post VFI dose, and on Days 4 
(± 1 day), 8 (± 1 day), 15 (± 1 day), and 21 (± 1 day). Pharmacokinetic samples for 
urine FD001 concentration determination in Cohorts 2 through 4 will be collected 
predose, from dosing (0 hour) to 2 hours postdose, and from 2 to 12 hours postdose. 
Subjects in Cohort 2 receiving a second VFI dose on Day 2 will follow the same urine 
collection schedule as Day 1. 
 
Plasma concentrations of FD001 and FD003 will be determined using a validated 
fluorometric assay. 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
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Criteria for Evaluation: 
continued 
Urine concentrations of FD001 will be determined using a validated method and 
concentration of FD001 will be multiplied by urine volume to determine the amount of 
excreted FD001. 
 
The following PK parameters will be calculated from the plasma and urine 
concentration/volume data using noncompartmental methods and actual sampling times: 
Cmax, tmax, AUC0-12 (FD001 only), AUClast, AUCinf, t½Ȝz, CL, CLr0-2 (FD001 only), 
CLr2-12 (FD001 only), CLr0 12 (FD001 only),Vz, Vss, Ae0-2, Ae0-2, and Ae0-12. 
 
Pharmacodynamics: 
Plasma Volume (Cohorts 1 through 4): Plasma volume will be determined using FAST 
PV Technology. 
 
Additionally, PV will be estimated using Nadler’s formula. 
 
Glomerular Filtration Rate (Cohort 1): Measured GFR will be determined using FAST 
mGFR Technology. 
 
Glomerular Filtration Rate (Cohorts 2 through 4): Measured GFR will be determined 
using FAST mGFR Technology and Iohexol clearance methods. Correlation analysis 
and Bland-Altman plots will be used to compare the FAST mGFR with Iohexol 
clearance. 
 
Additionally, eGFR will be calculated primarily using the CKD-EPI equations, with 
additional calculations being performed using the MDRD and Cockcroft-Gault 
equations (Cohorts 1 through 4). 
 
Planned Sample Size: 
Approximately 32 subjects/patients will be enrolled in 4 cohorts consisting of up to 
8 subjects/patients each. Only subjects in Cohorts 2 through 4 will contribute to the 
plasma concentration PK statistical analysis; plasma concentrations for subjects in 
Cohort 1 will be analyzed for CLr, Cmax, and using the FAST mGFR and PV 
measurement calculations only. 
 
The sample size in this study is representative of Phase 2b studies of this type. Power 
calculations were not used to derive the sample size. 
 
Statistical Analysis: 
Analysis Populations: 
Pharmacokinetic Full Population: All subjects in Cohorts 2 through 4 who receive a 
known amount of study drug and have at least one quantifiable concentration of FD001 
or FD003 in plasma or FD001 in urine and all subjects in Cohort 1 who receive a known 
amount of study drug. Plasma concentrations for subjects in Cohort 1 will not contribute 
to the overall PK statistical analysis and will be analyzed for CLr, Cmax, and using the 
FAST mGFR and PV measurement calculations only. 
 
Pharmacokinetic Evaluable Population: All subjects in Cohorts 1 through 4 who receive 
a known amount of study drug and have at least 1 estimable PK parameter. 
 
Safety Population: All subjects who received any amount of study drug. 
 
Pharmacodynamic Evaluable Population: All subjects in Cohorts 1 through 4 who have 
either a PV or GFR estimate using any of the techniques under study. Subjects in 
Cohort 1 will not contribute to the overall PD statistical analysis. 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
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Statistical Analysis: 
continued 
Pharmacokinetic Analysis: For Cohorts 2 through 4, subject plasma concentration-time 
profiles will be listed and summarized for each analyte by nominal sampling time. 
Summary statistics will be listed and summarized for each PK parameter by cohort and 
analyte. Plasma concentrations for subjects in Cohort 1 will not contribute to the overall 
PK statistical analysis and will be analyzed for CLr, Cmax, and using the FAST mGFR 
and PV measurement calculations only. 
 
Pharmacodynamic Analysis: 
Plasma Volume (Cohorts 2 through 4): 
The FAST Technology for determining PV will be compared to PV estimated using 
Nadler's formula. Plasma volume data will be listed and summarized by presenting 
descriptive statistics of raw data. The correlation as well as the associated plot will be 
presented for comparing PV between methods. Cosgriff et al. 1999 shows that a 
combination of the correlation and a histogram of the magnitude of difference is needed 
when no measured comparator is available. Subjects in Cohort 1 will not contribute to 
the overall PD statistical analysis. 
 
Glomerular Filtration Rate (Cohorts 2 through 4): 
Measured GFR determined using the FAST VFI Technology will be compared to the 
mGFR determined using the Iohexol clearance test. The results will be listed by subject 
and summarized by presenting descriptive statistics for each cohort. Correlation analysis 
and Bland-Altman plots will be used to compare the FAST mGFR with Iohexol 
clearance. Subjects in Cohort 1 will not receive Iohexol and will not contribute to the 
overall PD statistical analysis. 
 
Estimated GFR calculated using primarily the CKD-Epi equation in addition to the 
MDRD, and Cockcroft-Gault equations will be listed by subject and summarized by 
presenting descriptive statistics for each cohort. 
 
Safety Analysis:  
12-lead ECG, vital signs, pulse oximetry, and clinical laboratory test data (observed and 
change from baseline) will be summarized by cohort, time point, and treatment using 
appropriate descriptive statistics. Physical examination findings will be listed only. 
 
The number and percentage of subjects reporting any treatment-emergent AE (TEAE) 
will be tabulated by system organ class and preferred term, cohort, and treatment (coded 
using Medical Dictionary for Regulatory Activities). Treatment-emergent AEs will be 
further classified by severity and relationship to treatment. 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 15 of 81 
Table 2.1 
Schedule of Assessments and Procedures – Cohort 1 (Single-dose Administration of VFI)  
Study Procedure 
Screening Admissiona 
Treatment Period 
Discharge 
EOSb 
Study Day 
-21 to -2 
-1 
1 
2 
21 
(± 1) 
Nominal Time 
Relative to Start of 
VFI Bolus Injection 
- 
- 
Pre 
0 
15 
30 
60 
120 
130 
165 
195 
205 
310 
370 
480 
12 
24 
480 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
h 
h 
h 
Informed consent 
X 
 
 
Inclusion/exclusion 
criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
Height 
X 
 
 
Body weight 
X 
X 
 
 
X 
BMIc 
X 
X 
 
 
Medical and surgical 
history 
X 
Xd 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examination 
X 
X 
 
 
X 
X 
Vital signs and pulse 
oximetrye  
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECGe 
X 
X 
X 
X 
 
 
X 
Clinical laboratory 
testsf 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Xg 
 
X 
X 
Renal function 
assessmenth 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine protein to 
creatinine ratioi 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Serology (HIV, 
HBsAg, HCV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FSH (females only) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test 
(females only) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 16 of 81 
Table 2.1 
Schedule of Assessments and Procedures – Cohort 1 (Single-dose Administration of VFI)  
Study Procedure 
Screening Admissiona 
Treatment Period 
Discharge 
EOSb 
Study Day 
-21 to -2 
-1 
1 
2 
21 
(± 1) 
Nominal Time 
Relative to Start of 
VFI Bolus Injection 
- 
- 
Pre 
0 
15 
30 
60 
120 
130 
165 
195 
205 
310 
370 
480 
12 
24 
480 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
h 
h 
h 
Urine drugs of abuse 
and serum alcohol 
screen 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In-house residency 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
FAST VFI 
administration 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5% Albumin Infusion 
X 
 
 
FD001 and FD003 
PK/PD plasma and 
urine samples 
 
 
Refer to Table 2.4 for the PK and PD sampling schedule. 
AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
SAEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: BMI = body mass index; ECG = electrocardiogram; EOS = end-of-study; FSH = follicle-stimulating hormone; h = hours; HBsAg = hepatitis B 
surface antigen; HCV = hepatitis C virus; HIV = human immunodeficiency virus; m = minutes; PD = pharmacodynamic; PK = pharmacokinetic; Pre = predose; 
VFI = visible fluorescent injectate 
a. 
Assessments conducted upon clinical research unit admission will be used to reconfirm a subject’s eligibility for enrollment into the study. 
b. Subjects who terminate from the study early will have EOS procedures performed at the time of discontinuation. 
c. 
BMI will be calculated using the height obtained at screening. 
d. Interim medical and surgical history will be collected to determine if any changes have occurred since screening. 
e. 
Vital signs and ECGs will be measured after the subject has been resting quietly in a supine position or in the most recumbent position possible for at least 
5 minutes. 
f. 
Refer to Table 8.3 for a detailed list of clinical laboratory test parameters. 
g. Hematology and serum chemistry only. Glucose and total cholesterol measurements will not be reported at 480 minutes as the subject will not have been 
fasting for 8 hours prior.  
h. 
Measurement of serum blood urea nitrogen, serum creatinine, and calculation of estimated glomerular filtration rate (eGFR) using the Modification of Diet 
in Renal Disease (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009), and Cockcroft-Gault equations. 
i. 
Subjects should be fasting prior to urine protein to creatinine ratio measurement. 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 17 of 81 
NOTE: In the event that multiple postdose procedures are required to be conducted at the same nominal time point, the timing of PD blood sample collections 
will take priority over all other scheduled activities except for dosing. In practice, the following order is recommended: (1) ECG recording; (2) vital signs 
assessments; (3) PD blood sampling; (4) clinical laboratory tests sampling; (5) physical examination. Electrocardiograms and vital signs may be conducted up to 
15 and 10 minutes, respectively, prior to the nominal time to minimize the potential autonomic effects of blood draws on these measurements. 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 18 of 81 
Table 2.2 
Schedule of Assessments and Procedures – Cohort 2 (Repeat-dose Administration of VFI) 
Study 
Procedure 
Screening 
Admissiona 
Treatment Period 
Discharge 
Follow-up 
EOSb 
Study Day 
-21 to -2 
-1 
1 and 2 
3 
5 
9 
16 
22 
(± 1) 
(± 1) 
(± 1) 
(± 1) 
Nominal Time 
Relative to 
Start of VFI 
Bolus Injection 
- 
- 
Pre 
0 15 30 60 120 160 170 280 310 340 370 480 12 
24 
72 
168 
336 
480 
m m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
h 
h 
h 
h 
h 
h 
Informed 
consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/ 
exclusion 
criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
Height 
X 
Body weight 
X 
X 
X 
BMIc 
X 
X 
Medical and 
surgical history 
X 
Xd 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical 
examination 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
X 
Vital signs and 
pulse oximetrye 
X 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECGe 
X 
X 
X 
X 
X 
Clinical 
laboratory testsf 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Xg 
 
X 
Xg 
Xg 
Xg 
X 
Renal function 
assessmenth 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine protein to 
creatinine ratioi 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
Serology (HIV, 
HBsAg, HCV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FSH (females 
only) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test 
(females only) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 19 of 81 
Table 2.2 
Schedule of Assessments and Procedures – Cohort 2 (Repeat-dose Administration of VFI) 
Study 
Procedure 
Screening 
Admissiona 
Treatment Period 
Discharge 
Follow-up 
EOSb 
Study Day 
-21 to -2 
-1 
1 and 2 
3 
5 
9 
16 
22 
(± 1) 
(± 1) 
(± 1) 
(± 1) 
Nominal Time 
Relative to 
Start of VFI 
Bolus Injection 
- 
- 
Pre 
0 15 30 60 120 160 170 280 310 340 370 480 12 
24 
72 
168 
336 
480 
m m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
h 
h 
h 
h 
h 
h 
Urine drugs of 
abuse and 
serum alcohol 
screen 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In-house 
residency 
 
X 
X 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
FAST VFI 
administrationj 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
Iohexol 
administrationk 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
FD001 and 
FD003 PK/PD 
plasma and 
urine samples 
 
 
Refer to Table 2.5 for the PK and PD sampling schedule. 
Iohexol PD 
plasma samples 
 
 
Refer to Table 2.5 for the PK and PD sampling schedule. 
AEs 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
SAEs 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
medications 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: BMI = body mass index; ECG = electrocardiogram; EOS = end-of-study; FSH = follicle-stimulating hormone; h = hours; HBsAg = hepatitis B 
surface antigen; HCV = hepatitis C virus; HIV = human immunodeficiency virus; m = minutes; PD = pharmacodynamic; PK = pharmacokinetic; Pre = predose; 
VFI = visible fluorescent injectate 
a. 
Assessments conducted upon clinical research unit admission will be used to reconfirm a subject’s eligibility for enrollment into the study. 
b. Subjects who terminate from the study early will have EOS procedures performed at the time of discontinuation. 
c. 
BMI will be calculated using the height obtained at screening. 
d. Interim medical and surgical history will be collected to determine if any changes have occurred since screening. 
e. 
Vital signs and ECGs will be measured after the subject has been resting quietly in a supine position or in the most recumbent position possible for at least 
5 minutes. 
f. 
Refer to Table 8.3 for a detailed list of clinical laboratory test parameters. 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 20 of 81 
g. Hematology and serum chemistry only. Glucose and total cholesterol measurements will not be reported at 480 minutes as the subject will not have been 
fasting for 8 hours prior.  
h. Measurement of serum blood urea nitrogen, serum creatinine, and calculation of estimated glomerular filtration rate (eGFR) using the Modification of Diet 
in Renal Disease (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009), and Cockcroft-Gault equations. 
i. 
Subjects should be fasting prior urine protein to creatinine ratio measurement. The 24-hour measurement on Day 2 will also act as the predose measurement 
for VFI dose 2. An additional ratio will be calculated 24 hours post VFI dose 2. 
j. 
VFI administration on Day 2 will occur 24 hours following VFI administration on Day 1. 
k. 
Iohexol administration will only occur on Day 1. 
 
NOTE: In the event that multiple postdose procedures are required to be conducted at the same nominal time point, the timing of PK and PD blood sample 
collections will take priority over all other scheduled activities except for dosing. In practice, the following order is recommended: (1) ECG recording; (2) vital 
signs assessments; (3) PK and PD blood sampling; (4) clinical laboratory tests sampling; (5) physical examination. Electrocardiograms and vital signs may be 
conducted up to 15 and 10 minutes, respectively, prior to the nominal time to minimize the potential autonomic effects of blood draws on these measurements. 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 21 of 81 
Table 2.3.1 
UAB Schedule of Assessments and Procedures – Cohorts 3 and 4 (Single-dose Administration of VFI) 
Study 
Procedure 
Screening 
Treatment Period 
 
Discharge 
Follow-up 
EOSb 
Study Day 
-21 to -1 
1 
2 
4 
8 
15 
21 
(± 1) (± 1) (± 1) (± 1) 
Nominal 
Time 
Relative to 
Start of VFI 
Bolus 
Injection 
 
Pre 
(UAB) 
0 
15 
30 
60 
120 
160 
170 
280 
310 
340 
370 
480 
12 
24 
32 
72 
168 
336 
480 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
h 
h 
h 
h 
h 
h 
h 
Informed 
consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/ 
exclusion 
criteria 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In House 
Residency  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body weight 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
BMI c 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical and 
surgical 
history 
X 
Xa,d 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical 
examination 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
X 
Vital signs 
and pulse 
oximetrye 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECGe 
X 
Xa 
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Clinical 
laboratory 
testsf 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
Xg 
 
X 
 
Xg 
Xg 
Xg 
X 
Renal function 
assessmenth 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 22 of 81 
Table 2.3.1 
UAB Schedule of Assessments and Procedures – Cohorts 3 and 4 (Single-dose Administration of VFI) 
Study 
Procedure 
Screening 
Treatment Period 
 
Discharge 
Follow-up 
EOSb 
Study Day 
-21 to -1 
1 
2 
4 
8 
15 
21 
(± 1) (± 1) (± 1) (± 1) 
Nominal 
Time 
Relative to 
Start of VFI 
Bolus 
Injection 
 
Pre 
(UAB) 
0 
15 
30 
60 
120 
160 
170 
280 
310 
340 
370 
480 
12 
24 
32 
72 
168 
336 
480 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
h 
h 
h 
h 
h 
h 
h 
Urine protein 
to creatinine 
ratioi 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Serology 
(HIV, HBsAg, 
HCV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FSH (females 
only) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy 
Test (females 
only) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drugs of 
abuse and 
serum alcohol 
screen 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In-house 
residency 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
FAST VFI 
administration 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Iohexol 
administration 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
FD001 and 
FD003 PK/PD 
plasma 
samples 
 
Refer to Table 2.6 for the PK and PD sampling schedule. 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 23 of 81 
Table 2.3.1 
UAB Schedule of Assessments and Procedures – Cohorts 3 and 4 (Single-dose Administration of VFI) 
Study 
Procedure 
Screening 
Treatment Period 
 
Discharge 
Follow-up 
EOSb 
Study Day 
-21 to -1 
1 
2 
4 
8 
15 
21 
(± 1) (± 1) (± 1) (± 1) 
Nominal 
Time 
Relative to 
Start of VFI 
Bolus 
Injection 
 
Pre 
(UAB) 
0 
15 
30 
60 
120 
160 
170 
280 
310 
340 
370 
480 
12 
24 
32 
72 
168 
336 
480 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
h 
h 
h 
h 
h 
h 
h 
Iohexol PD 
plasma 
samples 
 
Refer to Table 2.6 for the PK and PD sampling schedule. 
AEs 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
SAEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
medications 
X 
Xa 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: BMI = body mass index; ECG = electrocardiogram; EOS = end-of-study; FSH = follicle-stimulating hormone; h = hours; HBsAg = hepatitis B 
surface antigen; HCV = hepatitis C virus; HIV = human immunodeficiency virus; m = minutes; PD = pharmacodynamic; PK = pharmacokinetic; Pre = predose; 
VFI = visible fluorescent injectate 
a. 
Assessments conducted upon clinical research unit admission will be used to reconfirm a patient’s eligibility for enrollment into the study. Coagulation 
(INR) not repeated at predose, only at screening. 
b. Patients who terminate from the study early will have EOS procedures performed at the time of discontinuation. 
c. 
BMI will be calculated using the height obtained at screening. 
d. Interim medical and surgical history will be collected to determine if any changes have occurred since screening. 
e. 
Vital signs and ECGs will be measured after the patient has been resting quietly in a supine position or in the most recumbent position possible for at least 
5 minutes. 
f. 
Refer to Table 8.3 for a detailed list of clinical laboratory test parameters. 
g. Hematology and serum chemistry only. Glucose and Total Cholesterol measurements will not be reported at 480 minutes as the patient will not have been 
fasting for 8 hours prior.  
h. Measurement of serum blood urea nitrogen, serum creatinine, and calculation of estimated glomerular filtration rate (eGFR) using the Modification of Diet 
in Renal Disease (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009), and Cockcroft-Gault equations. 
i. 
Patients should be fasting prior to urine protein to creatinine ratio measurement. 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 24 of 81 
NOTE: In the event that multiple postdose procedures are required to be conducted at the same nominal time point, the timing of PK and PD blood sample 
collections will take priority over all other scheduled activities except for dosing. In practice, the following order is recommended: (1) ECG recording; (2) vital 
signs assessments; (3) PK and PD blood sampling; (4) clinical laboratory tests sampling; (5) physical examination. Electrocardiograms and vital signs may be 
conducted up to 15 and 10 minutes, respectively, prior to the nominal time to minimize the potential autonomic effects of blood draws on these measurements. 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 25 of 81 
Table 2.3.2 
ICON Schedule of Assessments and Procedures – Cohorts 3  (Single-dose Administration of VFI) 
Study 
Procedure 
Screening 
Day -1 
(ICON 
Cohort 
3 Only) 
Treatment Period 
Discharge 
Follow-up 
EOSb 
Study Day 
-21 to -1 Day -1 
1 
2 
4 
8 
15 
21 
(± 1) (± 1) (± 1) 
(± 1) 
Nominal Time 
Relative to 
Start of VFI 
Bolus 
Injection 
 
 
Pre 
(ICO
N) 
0 
15 
30 
60 
120 160 170 280 310 340 370 480 
12 
24 
32 
72 
168 
336 
480 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
h 
h 
h 
h 
h 
h 
h 
Informed 
consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/ 
exclusion 
criteria 
X 
 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In House 
Residency 
(ICON Only)  
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body weight 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
BMI c 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical and 
surgical history 
X 
 
Xa,d 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical 
examination 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
X 
Vital signs and 
pulse 
oximetrye 
X 
 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECGe 
X 
Xa 
Xa 
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Clinical 
laboratory 
testsf 
X 
 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
Xg 
 
X 
 
Xg 
Xg 
Xg 
X 
Renal function 
assessmenth 
X 
 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 26 of 81 
Table 2.3.2 
ICON Schedule of Assessments and Procedures – Cohorts 3  (Single-dose Administration of VFI) 
Study 
Procedure 
Screening 
Day -1 
(ICON 
Cohort 
3 Only) 
Treatment Period 
Discharge 
Follow-up 
EOSb 
Study Day 
-21 to -1 Day -1 
1 
2 
4 
8 
15 
21 
(± 1) (± 1) (± 1) 
(± 1) 
Nominal Time 
Relative to 
Start of VFI 
Bolus 
Injection 
 
 
Pre 
(ICO
N) 
0 
15 
30 
60 
120 160 170 280 310 340 370 480 
12 
24 
32 
72 
168 
336 
480 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
h 
h 
h 
h 
h 
h 
h 
Urine protein 
to creatinine 
ratioi 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Serology 
(HIV, HBsAg, 
HCV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FSH (females 
only) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test 
(females only) 
 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drugs of 
abuse and 
serum alcohol 
screen 
 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In-house 
residency 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
FAST VFI 
administration 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Iohexol 
administration 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
FD001 and 
FD003 PK/PD 
plasma 
samples 
Refer to Table 2.6 for the PK and PD sampling schedule. 

FAST BioMedical 
Protocol Number: 36770001 
Final Protocol 1.1 
CONFIDENTIAL 
July 17th, 2017 Version 1.1 Monday, July 24, 2017 
Page 27 of 81 
Table 2.3.2 
ICON Schedule of Assessments and Procedures – Cohorts 3  (Single-dose Administration of VFI) 
Study 
Procedure 
Screening 
Day -1 
(ICON 
Cohort 
3 Only) 
Treatment Period 
Discharge 
Follow-up 
EOSb 
Study Day 
-21 to -1 Day -1 
1 
2 
4 
8 
15 
21 
(± 1) (± 1) (± 1) 
(± 1) 
Nominal Time 
Relative to 
Start of VFI 
Bolus 
Injection 
Pre 
(ICO
N) 
0 
15 
30 
60 
120 160 170 280 310 340 370 480 
12 
24 
32 
72 
168 
336 
480 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
m 
h 
h 
h 
h 
h 
h 
h 
Iohexol PD 
plasma 
samples 
Refer to Table 2.6 for the PK and PD sampling schedule. 
AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
SAEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: BMI = body mass index; ECG = electrocardiogram; EOS = end-of-study; FSH = follicle-stimulating hormone; h = hours; HBsAg = hepatitis B 
surface antigen; HCV = hepatitis C virus; HIV = human immunodeficiency virus; m = minutes; PD = pharmacodynamic; PK = pharmacokinetic; Pre = predose; 
VFI = visible fluorescent injectate 
D.
Assessments conducted upon clinical research unit admission will be used to reconfirm a patient’s eligibility for enrollment into the study. Coagulation
(INR) not repeated at predose, only at screening.
E.
Patients who terminate from the study early will have EOS procedures performed at the time of discontinuation.
F.
BMI will be calculated using the height obtained at screening.
G.
Interim medical and surgical history will be collected to determine if any changes have occurred since screening.
H.
Vital signs and ECGs will be measured after the patient has been resting quietly in a supine position or in the most recumbent position possible for at least
5 minutes.
I.
Refer to Table 8.3 for a detailed list of clinical laboratory test parameters.
J.
Hematology and serum chemistry only. Glucose and Total Cholesterol measurements will not be reported at 480 minutes as the patient will not have been
fasting for 8 hours prior.
K.
Measurement of serum blood urea nitrogen, serum creatinine, and calculation of estimated glomerular filtration rate (eGFR) using the Modification of Diet
in Renal Disease (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009), and Cockcroft-Gault equations.
L.
Patients should be fasting prior to urine protein to creatinine ratio measurement.

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NOTE: In the event that multiple postdose procedures are required to be conducted at the same nominal time point, the timing of PK and PD blood sample 
collections will take priority over all other scheduled activities except for dosing. In practice, the following order is recommended: (1) ECG recording; (2) vital 
signs assessments; (3) PK and PD blood sampling; (4) clinical laboratory tests sampling; (5) physical examination. Electrocardiograms and vital signs may be 
conducted up to 15 and 10 minutes, respectively, prior to the nominal time to minimize the potential autonomic effects of blood draws on these measurements. 

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Table 2.4 
Pharmacokinetic and Pharmacodynamic Sampling Schedule – Cohort 1 
(Single-dose Administration of VFI) 
Study Day 
Time (Relative to Start 
of VFI Bolus Injection) 
FD001 and FD003 
PK/PD Plasma Sample 
Time (Relative to Start of 
5% Albumin Infusion) 
1 
Predose 
X 
- 
0 
VFI Administration 
15 minutes 
X 
- 
30 minutes 
X 
- 
60 minutes 
X 
- 
120 minutes 
X 
- 
130 minutes 
5% Albumin Infusion Start (over 30 min) 
160 minutes 
5% Albumin Infusion Ends 
165 minutes 
X 
35 minutes 
195 minutes 
X 
65 minutes 
205 minutes 
X 
75 minutes 
310 minutes 
X 
180 minutes 
370 minutes 
X 
240 minutes 
480 minutes 
X 
350 minutes 
12 hours 
X 
- 
2 
24 hours 
X 
- 
Abbreviations: PD = pharmacodynamic; PK = pharmacokinetic; VFI = visible fluorescent injectate 
Note: Blood samples may not be collected from the same arm used for VFI administration. In the event that vascular 
access cannot be established in both arms, a single arm may be used with documentation in the subject’s records. 
PK/PD blood samples will be collected as close to the nominal time point as possible. Allowable windows for 
PK/PD blood sample collection relative to dosing will be as follows: within 30 minutes predose, ± 1 minute through 
205 minutes postdose , ± 2 minutes through 480 minutes postdose, and ± 10 minutes through 24 hours postdose. 
Subjects should evacuate their bladder prior to beginning 5% albumin infusion. 
 

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Table 2.5 
Pharmacokinetic and Pharmacodynamic Sampling Schedule - Cohort 2 
(Repeat-dose Administration of VFI) 
Study 
Day 
Time (Relative to 
Start of VFI Bolus 
Injection) 
FD001 and 
FD003 PK/PD 
Plasma Sample 
FD001 PK 
Urine Sample 
Time (Relative to 
Start of Iohexol 
Bolus Injection) 
Iohexol PD 
Plasma Sample 
1 
Predose 
X 
Xa 
Predose 
X 
0 minutes 
VFI Administration 
15 minutes 
X 
0 to 2 hoursb 
- 
- 
30 minutes 
X 
- 
- 
60 minutes 
X 
- 
- 
120 minutes 
X 
- 
- 
160 minutes 
Iohexol Administration 
170 minutes 
X 
2 to 12 hoursb 
10 minutes 
X 
280 minutes 
- 
120 minutes 
X 
310 minutes 
X 
150 minutes 
X 
340 minutes 
- 
180 minutes 
X 
370 minutes 
X 
210 minutes 
X 
480 minutes 
X 
320 minutes 
X 
12 hours 
X 
560 minutes 
X 
2 
Predose 
Xe 
- 
- 
- 
0 minutes 
VFI Administrationc 
15 minutes 
X 
0 to 2 hoursb 
- 
- 
30 minutes 
X 
- 
- 
60 minutes 
X 
- 
- 
120 minutes 
X 
- 
- 
170 minutes 
X 
2 to 12 hoursb 
- 
- 
310 minutes 
X 
- 
- 
370 minutes 
X 
- 
- 
480 minutes 
X 
- 
- 
12 hours 
X 
- 
- 
3 
24 hoursd 
X 
- 
- 
- 
5 
72 hours 
X 
- 
- 
- 
9 
168 hours 
X 
- 
- 
- 
16 
336 hours 
X 
- 
- 
- 
22 
480 hours 
X 
- 
- 
- 
Abbreviations: PD = pharmacodynamic; PK = pharmacokinetic; VFI = visible fluorescent injectate 
a. 
Subjects will be asked to void their bladder prior to VFI dosing; a small sample (~10mL) will be saved. 
b. Urine will be collected and pooled from time 0 through 2 hours and from 2 hours through 12 hours. A total 
volume of urine in each pool will be measured. Subjects will be asked to void their bladder at the 2 hour and the 
12 hour time point. Time of void should be recorded. 
c. 
VFI administration on Day 2 should occur 24 hours ± 1 hour after VFI administration on Day 1. 
d. Time relative to start of the second VFI administration. 
e. 
Predose PK/PD sample must be taken within 5 minutes prior to VFI dosing on Day 2. 
Note: Blood samples may not be collected from the same arm used for VFI administration. In the event that vascular 
access cannot be established in both arms, a single arm may be used with documentation in the subject’s records. 
PK/PD blood samples will be collected as close to the nominal time point as possible. Allowable windows for 
PK/PD blood sample collection relative to dosing will be as follows: within 30 minutes predose, ± 1 minute through 
170 minutes postdose, ± 2 minutes through 480 minutes postdose, ± 10 minutes through 24 hours postdose, and 
± 1 day through Day 22. In the event samples for VFI and Iohexol are scheduled to be taken at the same time, VFI 
samples should be taken first, followed by Iohexol samples. 

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Table 2.6 
Pharmacokinetic and Pharmacodynamic Sampling Schedule – Cohort 3 and 4 
(Single-dose Administration of VFI)  
Study 
Day 
Time (Relative to 
Start of VFI 
Bolus Injection) 
FD001 and 
FD003 PK/PD 
Plasma Sample 
FD001 PK 
Urine Sample 
Time (Relative to 
Start of Iohexol 
Bolus Injection) 
Iohexol PD Plasma 
Sample  
1 
Predose 
X 
Xa 
Predose 
X 
0 minutes 
VFI Administration 
15 minutes 
X 
0 to 2 hoursb 
- 
- 
30 minutes 
X 
- 
- 
60 minutes 
X 
- 
- 
120 minutes 
X 
- 
- 
160 minutes 
Iohexol Administration 
170 minutes 
X 
2 to 12 hoursb 
10 minutes 
X 
280 minutes 
- 
120 minutes 
X 
310 minutes 
X 
150 minutes 
X 
340 minutes 
- 
180 minutes 
X 
370 minutes 
X 
210 minutes 
X 
480 minutes 
X 
320 minutes 
X 
12 hours 
X 
560 minutes 
X 
2 
24 hours 
X 
 
- 
- 
32 hours 
X 
 
- 
- 
4 
72 hours 
X 
 
- 
- 
8 
168 hours 
X 
 
- 
- 
15 
336 hours 
X 
 
- 
- 
21 
480 hours 
X 
 
- 
- 
Abbreviations: PD = pharmacodynamic; PK = pharmacokinetic; VFI = visible fluorescent injectate 
a. 
Patients will be asked to void their bladder prior to VFI dosing; a small sample (~10mL) will be saved. 
b. Urine will be collected from time 0 through 2 hours and pooled and from 2 hours through 12 hours and pooled. 
A total volume of urine in each pool will be measured. Patients will be asked to void their bladder at the 2-hour 
and the 12-hour time point. Time of void should be recorded. 
 
Note: Blood samples may not be collected from the same arm used for VFI administration. In the event that vascular 
access cannot be established in both arms, a single arm may be used with documentation in the patient records. 
PK/PD blood samples will be collected as close to the nominal time point as possible. Allowable windows for 
PK/PD blood sample collection relative to dosing will be as follows: within 30 minutes predose, ± 1 minute through 
170 minutes postdose , ± 2 minutes through 480 minutes postdose, ± 10 minutes through 24 hours postdose, 
± 1 hour through 32 hours postdose and ± 1 day through Day 21. In the event samples for VFI and Iohexol are 
scheduled to be taken at the same time, VFI samples should be taken first, followed by Iohexol samples. 

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LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
Ȝz 
terminal elimination rate constant 
ADL 
activities of daily living 
AE 
adverse event 
Ae0-2 
amount of FD001 excreted unchanged in the urine from time 0 to 2 hours 
Ae2-12 
amount of FD001 excreted unchanged in the urine from time 2 to 12 hours 
Ae0-12 
amount of FD001 excreted unchanged in the urine from time 0 to 12 hours 
AIDS 
acquired immune deficiency syndrome 
AKI 
acute kidney injury 
AUC0-12 
area under the plasma concentration-time curve from time 0 to 12 hours 
AUCextrap 
area under the plasma concentration-time curve from the time of last observed concentration 
extrapolated to infinity expressed as a percent 
AUCinf 
area under the plasma concentration-time curve from time 0 extrapolated to infinity 
AUClast 
area under the plasma concentration-time curve from time 0 to the time of the last quantifiable 
concentration 
BP 
blood pressure 
bpm 
beats per minute 
BUN 
blood urea nitrogen 
BVA 
Blood Volume Analyzer 
CI 
confidence interval 
CKD 
chronic kidney disease 
CKD-EPI 
Chronic Kidney Disease Epidemiology Collaboration 
CL 
total body clearance 
CLr0-2 
Renal clearance from time 0 to 2 hours 
CLr2-12 
Renal clearance from time 2 to 12 hours 
CLr0-12 
Renal clearance from time 0 to 12 hours 
Clast 
last measurable concentration 
Cmax 
maximum observed concentration 
CRU 
clinical research unit 
CV% 
coefficient of variation 
CYP 
cytochrome P450 
DILI 
drug-induced liver injury 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
eGFR 
estimated glomerular filtration rate 

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Abbreviation 
Definition 
EOS 
end-of-study 
FD001 
5 kD carboxymethyl dextran 
FD003 
150 kD carboxymethyl dextran 
FD004 
liquid visible fluorescent injectate agent, combination of FD001 and FD003 in a 3:1 ratio  
FDA 
Food and Drug Administration 
FIH 
first-in-human 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GFR 
glomerular filtration rate 
GM 
geometric mean 
HBsAg 
hepatitis B surface antigen 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HR 
heart rate 
ICH 
International Council for Harmonisation, formerly the International Conference on 
Harmonisation 
IEC 
independent ethics committee 
INR 
international normalized ratio 
IRB 
institutional review board 
IV 
intravenous(ly) 
MDRD 
Modification of Diet in Renal Disease 
mGFR 
measured glomerular filtration rate 
MRTinf 
mean residence time extrapolated to infinity 
NADPH 
nicotinamide adenine dinucleotide phosphate 
OTC 
over-the-counter 
PD 
pharmacodynamic(s) 
PK 
pharmacokinetic(s) 
PR (interval) 
interval measured from the beginning of the P wave to the beginning of the QRS complex in the 
heart’s electrical cycle as measured by ECG 
PV 
plasma volume 
QRS (interval) 
the interval between the Q wave and the S wave in the heart’s electrical cycle as measured by 
ECG; principal deflection in the ECG 
QT (interval) 
a measure of the time between the start of the Q wave and the end of the T wave in the heart’s 
electrical cycle as measured by ECG 
QTc (interval) 
QT interval corrected for heart rate 
QTcF (interval) 
QT interval corrected for heart rate using Fridericia’s formula 

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Abbreviation 
Definition 
RR (interval) 
the time elapsed between 2 consecutive R waves as measured by ECG 
SAE 
serious AE 
SAP 
statistical analysis plan 
Scr 
serum creatinine 
SRC 
safety review committee 
t½ 
terminal elimination half-life 
TEAE 
treatment-emergent AEs 
tmax 
time at which the maximum concentration was observed 
ULN 
upper limit of normal 
VFI 
visible fluorescent injectate 
Vz 
volume of distribution during the terminal phase 
Vss 
volume of distribution at steady state 

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STUDY ADMINISTRATIVE STRUCTURE 
Sponsor: 
FAST BioMedical 
9650 Commerce Drive 
Suite 521 
Carmel, IN 46032, USA 
Telephone: (866) 700-7310 ext. 701 
Sponsor’s Responsible Medical Officer: 
Bruce Molitoris, MD 
FAST BioMedical 
Sponsor’s Contact: 
James Strickland, President 
FAST BioMedical 
Investigators and Clinical Research Units: 
Cohorts 1,  2 and 3: 
Emanuel DeNoia, MD 
ICON Early Phase Services, LLC 
8307 Gault Lane 
San Antonio, TX 78209, USA 
Telephone: (210) 283-4500 
Fax: (210) 853-0840 
Cohorts 3 and 4: 
Dana V. Rizk, MD 
University of Alabama Birmingham 
Division of Nephrology 
ZRB614 
1720 2nd Ave South 
Birmingham, AL 35294, USA 
Telephone: (205) 934-9509 
Medical Monitor: 
David Braitman, PhD 
ICON Development Solutions, LLC 
820 West Diamond Avenue, Suite 100 
Gaithersburg, MD 20878, USA 
Mobile: (410) 818-8043 

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Clinical Research Organization: 
ICON Clinical Research, LLC 
820 West Diamond Avenue, Suite 100 
Gaithersburg, MD 20878, USA 
Telephone: (301) 944-6800 
Fax: (215) 699-6288 
Bioanalytical Laboratories: 
Fluorometric Assay: 
Sarah Swenson 
MRIGlobal 
425 Volker Boulevard 
Kansas City, MO 64110, USA 
Telephone: (816) 326-5033 
Iohexol Clearance: 
Jesse Seegmilller, PhD 
Assistant Professor Dept. Lab. Med. and 
Pathology 
University of Minnesota  
Advanced Research & Diagnostic Laboratory 
Room D185 Mayo Bldg.  
420 Delaware St. S.E. 
Minneapolis, MN 55455 
Office Telephone: (612) 625-6198 
FAST mGFR Test™ 
Dan Meier, PhD 
Vice President of Product Development 
FAST BioMedical 
9650 Commerce Dr. 
Suite 521 
Caramel, IN 46032 
Telephone: (866) 700-7310 
Certified clinical laboratories will be used for this study. Contact information will be specified in 
a separate study reference manual. 

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3 
INTRODUCTION AND BACKGROUND 
3.1 
Introduction 
A rapid and accurate measurement of plasma volume (PV) and glomerular filtration rate (GFR) 
is important in acute kidney injury (AKI) and chronic kidney disease (CKD) for assessment of 
impairment, diagnosis, and prompt treatment. 
Reductions in PV and/or GFR secondary to kidney injury, either acute or chronic, are 
accompanied by increases in blood urea nitrogen (BUN) and serum creatinine (Scr) levels. 
Currently, either Scr, or an equation based on Scr, is used to determine a patient’s estimated GFR 
(eGFR). Unfortunately, these 2 approaches are not reliable over the full range of GFR, and 
neither can be used for early detection or functional assessment in patients with a rapidly 
changing GFR, such as patients with AKI. 
Recent data indicate that even very small changes in Scr, which were previously thought to be 
clinically insignificant, are now known to predict an increased mortality rate. A technique to 
measure PV and GFR rapidly would be valuable to detect the loss of kidney function that leads 
to these acute changes in Scr so that treatment can begin as soon as possible. 
Glomerular filtration rate is the most clinically relevant metric for understanding renal function, 
as it is the rate by which the kidney is able to filter waste products in the bloodstream. Accurate 
measurement of GFR in acutely ill patients could also facilitate accurate dosing of drugs to 
maximize therapeutic efficacy while minimizing toxicity. Therefore, technical advances in this 
field are of major clinical importance, especially in high-risk patients where intense surveillance 
is necessary. 
3.2 
Investigational Device Background 
The FAST PV and mGFR Technology™ is a direct measurement of PV and GFR that relies on 
reading the concentration of fluorescent markers attached to different size dextran molecules 
introduced into the bloodstream. The test is intended as an adjunct to current methods utilized to 
assess kidney function. 
The FAST PV and mGFR Technology includes intravenously (IV) administered fluorescent 
markers, timed blood draws, a validated fluorometric assay, and a computed algorithm to 
integrate the results and calculate the GFR. 
The FAST PV and mGFR Technology will aid in identifying and determining the extent of renal 
dysfunction, therefore promoting early treatment, including dialysis initiation, as well as 
enrollment and stratification for clinical studies. It could also be used to determine the effect of a 
clinical maneuver on GFR such as volume resuscitation. 

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3.3 
Investigational Product Background 
The IV administered visible fluorescent injectate (VFI)™ agent is comprised of a mixture of 
2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different 
fluorescent dye molecules attached. The 5 kD carboxymethyl dextran (FD001) is labeled with 
5-aminofluorescein and the 150 kD carboxymethyl dextran (FD003) is labeled with 
2-sulfohexamine rhodamine. These fluorescent labels are covalently attached to the dextran 
through the carboxymethyl moiety. When combined in a 3:1 (mass) ratio of small to large 
molecules, these dextrans make up the VFI, termed FD004. 
The high molecular weight labeled carboxymethyl dextran, FD003, is not rapidly cleared from 
the vasculature and is not rapidly cleared by passive filtration in the kidneys; therefore, its 
concentration in the blood stream after injection provides a direct measurement of the total PV. 
The low molecular weight labeled carboxymethyl dextran, FD001, is also not subject to rapid 
metabolism but is freely filtered by the kidneys. The decline in the concentration of FD001 
combined with the PV measured by FD003 provides a rapid and accurate assessment of GFR. 
The VFI is administered IV through a bolus injection. 
While the VFI is a substantially modified dextran-based compound, other dextran products have, 
on rare occasions, been associated with mild to severe, acute anaphylactic reactions including 
death. As a precaution, subjects will be closely monitored for signs of allergy and anaphylaxis, 
and an emergency resuscitation kit and team will be available within the clinical research unit 
(CRU) throughout the treatment period. 
Fluorescent dyes such as fluorescein, which is also used in the VFI, are known to cause transient 
ocular light sensitivity, although this effect was not reported at any dose studied in the previous 
first-in-human (FIH) or phase 2a clinical study. Should this effect be observed, subjects will be 
provided with disposable protective sunglasses to wear until the effect is reversed. 
3.4 
Summary of Findings to Date 
3.4.1 
Nonclinical Studies 
Proof-of-concept nonclinical pharmacology studies have been conducted in dogs to confirm the 
assessment of GFR using the FAST mGFR Test™ (Wang 2011). The results of these studies 
provide evidence that the method, in combination with the VFI, provides an accurate GFR. 
The liquid VFI agent (FD004) was evaluated in a full range of nonclinical studies, including 
pharmacology, safety pharmacology, pharmacokinetic (PK), single-dose toxicity, genotoxicity, 
and immunotoxicity in male and female rats and dogs at concentrations from 16 (FD003) to 
26 (FD001) fold greater than the planned maximum human dose based upon observed and 
predicted area under the concentration-time curve (AUC) values. For more information please 
refer to the current Investigator’s Brochure. 

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Observed effects of the VFI (FD001 and FD003) in pivotal single dose animal studies at higher 
doses (ranging from approximately 62 to approximately 100 times the planned human clinical 
dose of 47 mg [29 mg/m2]) included emesis in dogs, discolored urine, and a species specific 
effect (rats not dogs) on tissue macrophages of the lymph nodes and spleen resulting in cell 
death, which did not reverse during the recovery period. The clinical relevance of the 
macrophage finding in rats is unknown. 
Though the VFI has shown no pharmacological activity at the human dose in receptor screening, 
a cytochrome P450 (CYP) inhibition study has been performed to assess potential for interaction 
with concomitant medications. The ability of FD001 and FD003 to inhibit CYP isoforms, 
CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5, was assessed to 
identify the potential of drug-drug interactions. FD001 and FD003 were each preincubated for 
0 or 30 minutes at 7 concentrations (0.1, 0.3, 1, 3, 10, 30, and 100 μM) with human liver 
microsomes in the presence of probe substrates phenacetin, efavirenz, amodiaquine, diclofenac, 
mephenytoin, dextromethorphan, midazolam, and testosterone to determine if there was a direct 
effect on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5, 
respectively. Additionally, FD001 and FD003 were each incubated in the presence of 
dihydronicotinamide-adenine dinucleotide phosphate (NADPH) for up to 30 minutes at 37°C to 
assess the time-dependent inhibitory effects on CYP enzymes. 
Results from the CYP inhibition studies suggest that: 
x FD001 does not inhibit any CYP enzyme examined (ie, CYP1A2, CYP2B6, CYP2C8, 
CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 [using 2 different substrates midazolam and 
testosterone]). 
x FD003 is a direct inhibitor of CYP2B6, CYP2C8, CYP2C19, and CYP3A4/5 (midazolam). 
x The R1 values associated with the direct inhibition of CYP2B6, CYP2C8, CYP2C19, and 
CYP3A4/5 (midazolam) by FD003 are all less than 1.1, signifying little likelihood that 
FD003 may cause clinically relevant drug interactions due to direct inhibition in vivo. 
x FD003 did not directly inhibit CYP1A2, CYP2C9, CYP2D6, or CYP3A4/5 (as measured by 
WHVWRVWHURQHȕ-hydroxylation; testosterone). 
x FD003 was a time-dependent inhibitor of CYP3A4/5 (as measured by testosterone 
ȕ-hydroxylation) since the IC50 value shifted from > 100 μM with no preincubation to 
49 μM after FD003 was preincubated with NADPH-fortified human liver microsomes for 
30 minutes. However, this time-dependent inhibition was only apparent in the presence of 
concentrations of FD003 greater than 10 μM, or approximately 1500 times the total bound 
and unbound plasma maximum observed concentration (Cmax) of 0.9 μg/mL (0.0066 μM). 

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x FD003 did not cause time-dependent inhibition of any other CYP enzyme examined 
(ie, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5 [as 
measured by midazolam 1´-hydroxylation]). 
FAST has completed pre-clinical work in dogs to assess the robustness and effectiveness of the 
PV measurement. Normal saline (350 mL) was infused over 10 minutes into a healthy, 
anesthetized, fasting dog. Multiple blood samples were drawn pre- and post-infusion to allow 
FAST to monitor the change in volume status in response to the volume challenge. The results 
(Figure 3.1) showed an immediate increase in volume, followed by a slower return to 
equilibrium. 
Figure 3.1 
The results of a FAST Plasma Volume Measurement Volume Challenge Test 
in a healthy dog model. 
3.4.2 
First-in-Human Study 
A FIH study, representing the first human use of the VFI, was concluded in 2012. Data from the 
study indicated that the FAST PV and mGFR Technology is safe and well tolerated. In this 
study, 32 subjects were enrolled with 8 subjects (6 VFI + 2 placebo) assigned to 1 of 4 dose 
groups. The VFI agent consisted of a mixture of 2 different molecular weight carboxymethyl 
dextran molecules (5 kD [FD001] and 150 kD [FD003]) with different fluorescent dye molecules 
attached. Four increasing doses were administered through a bolus injection: Group 1, 
5 mg/0.1 mL VFI; Group 2, 15 mg/0.3 mL VFI; Group 3, 75 mg/1.5 mL VFI; Group 4, 
150 mg/3 mL VFI. 
All 32 subjects completed the study as planned and were included in the safety analysis. Overall 
9 subjects (28.1%) experienced 15 treatment-emergent adverse events (TEAEs) which were 
considered by the investigator to be reasonably related to VFI administration or study 
procedures. Most related TEAEs were observed after administration of 15 mg VFI (9 TEAEs 
reported by 3 subjects). No related TEAEs were observed after the highest dose. Only 2 subjects 
(both 15 mg VFI) reported 6 TEAEs (pruritus and gastrointestinal disorders) which were 
considered related to VFI administration. All other related TEAEs were judged to be related to 

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the study procedures (mainly injection site pain and hematoma at the blood sampling site). All 
TEAEs were of mild to moderate intensity. There were no serious adverse events (SAEs); no 
subject discontinued the study due to adverse events (AEs). Safety laboratory parameters, vital 
signs, and electrocardiogram (ECG) parameters showed no clinically relevant time- or 
treatment-related effects or differences between dose groups. 
All subjects who received VFI were included in the PK analysis. Geometric mean AUC and Cmax 
of FD001 and FD003 increased dose-proportionally. FD001 had a median time at which the 
maximum concentration was observed (tmax) of 0.25 hours for all doses; median tmax of FD003 
was about 0.5 hours for the 2 lower doses and 2 hours for the 2 higher doses. FD001 was 
eliminated with a short elimination half-life (t½) of about 1.5 to 4 hours; mean t½ for FD003 was 
considerably longer ranging from 47 to 111 hours. Detailed PK data is available in the 
Investigator’s Brochure for this study. 
3.4.3 
Phase 2a Study at University of Alabama at Birmingham 
For the Phase 2a study completed in 2015 at the University of Alabama at Birmingham, 
5 cohorts with a total of 33 patients were studied. The primary endpoint of the study was to 
establish safety of the IV administered VFI. This end point was achieved, and even with 
increasing severity of CKD, with its associated comorbidities, no SAEs were reported during the 
study. A relatively small number of AEs were reported as potentially related to the VFI. The 
FAST BioMedical measured GFR (mGFR) was evaluated by performing an Iohexol study along 
with standard estimates of GFR using creatinine and cystatin C values and both Modification of 
Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration 
(CKD-EPI) equations. The breakdown of patients and GFR ranges in each cohort is listed in 
Table 3.2. 
Table 3.2 
Phase II Patients by Cohort  
Cohort 
Type of Patient 
eGFR 
1 
Normal 
60 mL/min 
2 
CKD 
30-59 mL/min 
3 
CKD 
15-29 mL/min 
4 
AKI 
AKI 
5 
Normal 
60 mL/min 
Following the enrollment of 1 hospitalized patient in Cohort 4 (AKI) the decision to stop 
enrolling patients into this cohort and stop the study was made. At that point, 33 of the originally 
planned 38 patients had been enrolled into the study. The decision for stopping enrollment was 
related to the anticipated time to enroll patients into the AKI cohort because in the opinion of the 
Principal Investigator and FAST management the enrollment criteria, developed to ensure the 
safety and appropriate evaluation of the CKD population, were too restrictive to enable 
enrollment of the originally planned AKI patients. Secondary rationale for stopping enrollment 

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was the expiry of the clinical VFI manufactured in June of 2011, and the inability to extend the 
label dating due to purity issues with the reference materials used to calibrate the stability assay. 
Subsequently, upon review of the medical history of the single patient enrolled in Cohort 4, it 
was determined that while this patient had a declining kidney function and was being treated 
clinically as an AKI patient, the patient did not meet either the Acute Kidney Injury Network 
stage “2” or Rifle (risk [class R], injury [class I] and failure [class F] + 2 outcome classes [loss 
and end-stage kidney disease]) stage “I” enrollment criteria. This was noted as a protocol 
deviation. 
A secondary endpoint of the study was to compare the kidney function quantified by the FAST 
VFI technique to that determined by existing measurements including Iohexol clearance 
(Cohorts 1, 2, 3, and 5) and serum biomarkers including cystatin C and creatinine for eGFR 
(calculated by the MDRD and CKD-EPI equations). Iohexol was omitted from Cohort 4, per 
protocol, because methodological differences between the 2-marker, 2-hour FAST BioMedical 
technology and the single-marker 6-hour Iohexol test would not provide comparable results in 
patients with a dynamically changing GFR, such as can be expected in AKI. 
Both Iohexol and the FAST mGFR technologies utilized timed blood draws and subsequent 
concentrations to calculate a predicted total AUC. The dose of marker given was divided by this 
AUC to calculate the mGFR, with scaling based on body surface area. The FAST mGFR utilized 
3 blood draws taken at early time points out to 2 hours. A fourth virtual point was calculated 
based on the PV at T0 (the starting concentration in the plasma just after the dose is given or 
time 0). The Iohexol GFR 6 test utilized a blank, plus a minimum of 6 additional blood draws 
taken over 6 hours to determine the AUC. Iohexol, having a much smaller molecular size, 
distributes differently within the extracellular space, so some difference in mGFR between the 
2 markers was anticipated. FAST BioMedical expected to measure mGFR values slightly lower 
than Iohexol in normal patients, as most single marker systems like Iohexol have difficulty 
resolving the early decay phase when the clearance is rapid. It was expected that the FAST 
mGFR measurements would be within 10% in the lower GFR groups. Prior studies conducted by 
FAST BioMedical using both the VFI and Iohexol in anesthetized dogs, have shown there were 
differences between the 2 methods. Analysis of the single marker decay rate showed that it 
normally resolved to a falsely high volume of distribution making the resulting mGFR biased 
higher than the FAST 2 marker system, which quantifies the initial volume of marker 
distribution. This small error in AUC was only significant in mGFRs above 80 mL/min. 
In addition to studying a range of GFRs using different measurement techniques, FAST 
BioMedical intended to evaluate FAST’s measured PV method against a standard clinical 
estimate of PV, specifically Nadler’s Formula (Nadler et al 1962). 
Plasma Volume (males) = 0.3669 × (Height [m])3 + 0.03219 × (Body Weight [kg]) + 0.6041 
Plasma Volume (females) = 0.3561 × (Height [m])3 + 0.03308 × (Body Weight [kg]) + 0.1833 

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The difference between a measured and estimated PV are between plus 20% to minus 30% 
(Feldschuh and Enson, 1977) using radioiodinated human serum albumin as the measured 
plasma marker. Since Nadler’s work was based primarily on measurements in healthy subjects, it 
was expected there may be a greater range seen with the CKD population in this study. 
Pharmacokinetic data analysis was performed on Cohorts 2, 3 and 5. The results indicated that 
the VFI performed as expected over the course of the study and corresponded well to the 
measured renal function and PV of the subjects. 
Following administration of 75 mg VFI by IV bolus injection to adults with preserved kidney 
function and impaired kidney function it was concluded that the mean plasma concentrations of 
FD001 exhibited little variability within study groups for samples collected from 0.25 to 
24 hours. Plasma FD001 concentrations generally reached Cmax following the end of the infusion 
and decreased in a multi-exponential, first-order elimination manner with early-phase 
distribution apparently complete at 8 to 12 hours and measureable concentrations observed in all 
subjects at 24 hours. Median plasma FD001 tmax values were 0.25 hours, the time of the first post 
administration sample collection in all study groups. Mean plasma FD001 t½ estimates were 
5.64, 9.48, and 18.3 hours for Groups 5, 2, and 3, respectively, increasing with decreasing renal 
function. Mean FD001 CL decreased with decreasing renal function. No significant differences 
between groups were observed in FD001 Cmax (p = 0.6751), tmax (p = 0.7418), Vss (p = 0.8425), 
or Cmax/Dose (p = 0.4781); and anticipated differences were observed in FD001 
AUClast (p < 0.0001), t½,z (p = 0.0015), CL (p < 0.0001), and AUCinf/Dose (p < 0.0001). 
Following administration of 75 mg VFI by IV bolus injection to adults with preserved kidney 
function and impaired kidney function, mean plasma FD003 concentrations exhibited little 
variability within study groups for samples collected from 0.25 to 504 hours. Plasma FD003 
concentrations reached maximum concentrations within 1 hour in all study groups and decreased 
in a mono-exponential, first-order elimination manner with measureable concentrations observed 
in all subjects at 504 hours. The observed half-life of FD003 ranged from 90 hours for healthy 
subjects to 125 hours for patients with severely impaired kidney function H*)5 15 and 
< 30 mL/min/1.73 m2) and were generally similar irrespective of renal function. Mean FD003 
volume estimates indicated that FD003 appeared to occupy a volume space that corresponds with 
PV. Mean FD003 CL did not change with decreasing renal function. No significant differences 
were observed in FD003 Cmax (p = 0.0743), tmax (p = 0.0600), AUClast (p = 0.8469), 
AUCinf (p = 0.8684), t ½,z (p = 0.0508), Vz (p = 0.2644), Vss (p = 0.3305), CL (p = 0.5048), 
Cmax/Dose (p = 0.1652), or AUCinf/Dose (p = 0.5048). A delay in the dispersion of the FD003 
molecule initially after dosing resulting in a later than anticipated Cmax. Complete PK data for the 
Phase 2a study is located in the Investigator’s Brochure from this study. 
3.5 
Iohexol Background 
OMNIPAQUE™ 300 (hereafter referred to as Iohexol) is indicated in adults for aortography 
including studies of the aortic arch, abdominal aorta and its branches, contrast enhancement for 

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computed tomographic head and body imaging, cerebral arteriography, peripheral venography 
(phlebography), and excretory urography. 
Following intravascular injection, Iohexol is distributed in the extracellular fluid compartment 
and is excreted unchanged by glomerular filtration. It will opacify those vessels in the path of 
flow of the contrast medium permitting radiographic visualization of the internal structures until 
significant hemodilution occurs. 
Approximately 90% or more of the injected dose is excreted within the first 24 hours, with the 
peak urine concentrations occurring in the first hour after administration. Plasma and urine 
Iohexol levels indicate that the Iohexol body clearance is due primarily to renal clearance (CLr). 
An increase in the dose from 500 to 1500 mgI/kg does not significantly alter the clearance of the 
drug. The following PK values were observed following the IV administration of Iohexol 
(between 500 to 1500 mgI/kg) to 16 adult human subjects: CLr, 120 (86 to 162) mL/min; total 
body clearance (CL), 131 (98 to 165) mL/min; and volume of distribution, 
165 (108 to 219) mL/kg. 
Renal accumulation is sufficiently rapid that the period of maximal opacification of the renal 
passages may begin as early as 1 minute after IV injection. Urograms become apparent in about 
1 to 3 minutes with optimal contrast occurring between 5 to 15 minutes. In nephropathic 
conditions, particularly when excretory capacity has been altered, the rate of excretion may vary 
unpredictably, and opacification may be delayed after injection. Severe renal impairment may 
result in a lack of diagnostic opacification of the collecting system and, depending on the degree 
of renal impairment, prolonged plasma Iohexol levels may be anticipated. In these patients, the 
route of excretion through the gallbladder and into the small intestine may increase. 
Iohexol displays a low affinity for serum or plasma proteins and is poorly bound to serum 
albumin. 
No significant metabolism, deiodination, or biotransformation occurs. 
Iohexol enhances computed tomographic imaging through augmentation of radiographic 
efficiency. The degree of density enhancement is directly related to the iodine content in an 
administered dose; peak iodine blood levels occur immediately following rapid IV injection. 
Blood levels fall rapidly within 5 to 10 minutes and the vascular compartment half-life is 
approximately 20 minutes. This can be accounted for by the dilution in the vascular and 
extravascular fluid compartments which causes an initial sharp fall in plasma concentration. 
Equilibration with the extracellular compartments is reached in about 10 minutes; thereafter, the 
fall becomes exponential. 
Refer to the OMNIPAQUE (Iohexol) injection prescribing information (2010) for additional 
details. 

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3.6 
Study Rationale 
3.6.1 
Rationale for Dose Selection 
Doses of VFI for this study were selected based on results of the Phase 1 FIH study in healthy 
subjects and in the Phase 2a study in subjects with normal and compromised renal function, as 
well as from data obtained in nonclinical studies (additional information is provided in the 
Investigator’s Brochure). 
Data from the FIH study evaluating the safety of the FAST PV and mGFR Technology in 
healthy adult subjects indicated the study dose of 75 mg/1.5 mL VFI was appropriate for the 
Phase 2a study. Data from the Phase 2a study and improvements to the FAST PV and mGFR 
Technology have indicated that, in the planned Phase 2b study, a single administration of VFI 
47 mg/3 mL is expected to be well tolerated and easily measured in all subjects. Additionally, for 
Cohort 2, where subjects will receive 2 doses of VFI, each dose being 47 mg/3mL it is expected 
that it will be well tolerated. As the FD001 marker is cleared and the doses are separated by 
24 hours, the maximum level of FD001 in the subjects after the second dose is not anticipated to 
exceed the dose of 52.5 mg of FD001 given in Phase 2a. Also, as the amount of FD003 has been 
reduced in the new VFI formulation, a second dose of VFI will result in values close to the 
amount previously dosed to subjects. In the Phase 2a clinical study a dose of 22.5 mg of FD003 
was given, for Phase 2b the maximum amount of FD003 to be given following repeat dosing is 
24 mg. This repeat-dose strategy was agreed to by FDA in written correspondence dated 
February 24, 2016. The predose sample taken on Day 2 for Cohort 2 will be analyzed and 
provide the residual amount of both FD001 and FD003. The FD003 residuals can then be 
subtracted as would a normal predose sample from the values of the post-second-administration 
samples to allow for a clean calculation of PV. FAST has derived the mathematical equations for 
GFR to appropriately compensate for any residual FD001; however, these normal subjects are 
not anticipating a residual level of FD001 in subjects on Day 2 that would affect the GFR 
calculation. Repeat doses of VFI are likely to be undertaken clinically as a method of evaluating 
treatments. These repeat measurements would not be done rapidly as a treatment required time to 
be effective. FAST chose 24 hours to separate VFI doses to mimic likely clinical situations. 
Similarly, in Cohort 1 a volume challenge is being administered to mimic the dynamic volume 
changes that most likely prompt the use of the FAST PV Technology. By administering a 
volume challenge to healthy individuals FAST will be able to observe the effectiveness of the 
FAST VFI with regards to dynamic changes in the plasma volume over time in a safe and 
controlled manner. 
3.6.2 
Rationale for Study Design 
This is a Phase 2b prospective, open-label study designed to evaluate the safety, tolerability, PK, 
and pharmacodynamics (PD) of the FAST PV and mGFR Technology in healthy adult subjects 
and patients with renal impairment. 

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Male and female subjects will be enrolled in the study. As no sufficient data are available on a 
potential influence of the investigational medicinal products on embryo-fetal development, 
female subjects must be of non-childbearing potential or must provide confirmation of a known 
and medically acceptable contraception method. Reproductively active men must agree to either 
practice abstinence or utilize adequate contraception. 
Subject safety will determine the progression or discontinuation of the study. In rare cases, 
dextran products have been documented to produce anaphylactic reactions in humans, and the 
onset of symptoms is documented to be acute. Though the FAST VFI is a substituted dextran 
product, and has shown little evidence of antigenicity in nonclinical studies, a cautious approach 
to dosing sequence is proposed. 
The duration of confinement and medical surveillance are considered adequate to ensure safety 
of the subjects. 
3.7 
Hypotheses 
This is an exploratory pilot investigation without any formal statistical hypotheses. All results 
will only be interpreted descriptively. Correlation, analysis and Bland-Altman plots will be used 
to compare the FAST mGFR with Iohexol clearance. 

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4 
OBJECTIVES 
4.1 
Primary Objectives 
x To assess the safety and tolerability of VFI (employing the FAST PV and mGFR 
Technology) compared to Iohexol (employing Iohexol clearance methods) in healthy subjects 
and patients with impaired renal function 
x To evaluate the PK of FD001 and FD003 in healthy subjects and patients with impaired renal 
function 
x To evaluate the PK of FD001 and FD003 in healthy subjects receiving 2 doses of VFI 
separated by 24 hours to evaluate the reproducibility of the FAST mGFR Technology 
4.2 
Secondary Objectives 
x To evaluate the relationship between FAST PV and mGFR Technology and standard clinical 
formulaic estimates of PV in healthy subjects 
x To evaluate and compare GFRs determined from FAST PV and mGFR Technology and 
Iohexol clearance methods in healthy subjects and patients with impaired renal function 
x To evaluate the GFR measurements in relation to current clinical eGFR equations in healthy 
subjects and patients with impaired renal function 
x To evaluate the FAST PV Technology’s ability to measure changes in vascular plasma 
volume resulting from a fluid challenge after the baseline PV measurement 

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5 
STUDY DESIGN 
5.1 
Study Design and Overview 
This is a Phase 2b, prospective, open-label study designed to evaluate the safety, tolerability, PK, 
and PD of FAST PV and mGFR Technology in healthy subjects and patients with varying 
degrees of renal impairment. 
For Cohorts 1 and 2, administration of the study drug will occur within 21 days of screening. 
Eligible subjects will be admitted to the CRU on Day -1, at which time assessments will be 
performed, and results from both screening and Day -1 (inclusion/exclusion criteria, body 
weight, height [screening only], body mass index [BMI], medical and surgical history, physical 
examination, vital signs and pulse oximetry, 12-lead ECG, clinical laboratory tests, renal 
function assessment, follicle-stimulating hormone [FSH; screening only] and pregnancy test 
[females only], urine drugs of abuse, and serum alcohol screen) will be reviewed to confirm 
eligibility. 
For Cohorts 3 and 4, administration of the study drug will occur within 21 days of screening.  
Eligible patients enrolled at UAB will be admitted to the CRU on Day 1, at which time 
assessments will be performed and results from both screening and predose administration 
testing (inclusion/exclusion criteria, body weight, height [screening only], BMI, medical and 
surgical history, physical examination, vital signs and pulse oximetry, 12-lead ECG, clinical 
laboratory tests, renal function assessment, FSH [screening only] and pregnancy test [females 
only], urine drugs of abuse, and serum alcohol screen) will be reviewed to confirm eligibility. 
Eligible patients enrolled into Cohort 3 at ICON Early Phase Services, LLC will be admitted to 
the CRU on Day -1 and will remain resident in the CRU through discharge on Day 2. Eligible 
subjects will be admitted to the clinical research unit (CRU) on Day -1, at which time 
assessments will be performed, and results from both screening and Day -1 (inclusion/exclusion 
criteria, body weight, height [screening only], body mass index [BMI], medical and surgical 
history, physical examination, vital signs and pulse oximetry, 12-lead ECG, clinical laboratory 
tests, renal function assessment, follicle-stimulating hormone [FSH; screening only] and 
pregnancy test [females only], urine drugs of abuse, and serum alcohol screen) will be reviewed 
to confirm eligibility. 

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The planned dose cohorts are presented in Table 5.1. 
*Subjects in Cohort 1 will receive a volume challenge 
Cohort 1: 
Eligible subjects  50 kg in weight will receive a single dose of VFI followed 130 minutes later 
by a 350 mL infusion of 5% albumin over 30 minutes on Day 1. Eligible subjects < 50 kg in 
weight will receive a single dose of VFI followed 130 minutes later by a maximum infusion of 
5% albumin of 7 mL/kg over 30 minutes on Day 1. Subjects will remain resident in the CRU for 
at least 24 hours after VFI administration for safety, PK, and PD assessments. Subjects will 
return to the CRU for an end-of-study (EOS) visit on Day 21 (± 1 day). 
Cohort 2: 
Eligible subjects will receive a dose of VFI followed 160 minutes later by a single dose of 
Iohexol on Day 1 and a second dose of VFI 24 hours following the initial dose of VFI. Subjects 
will remain resident in the CRU for at least 24 hours after the second VFI administration for 
safety, PK, and PD assessments. Subjects will return to the CRU for follow-up visits on Days 5 
(± 1 day), 9 (± 1 day), and 16 (± 1 day) and an EOS visit on Day 22 (± 1 day). 
Cohorts 3 and 4: 
Eligible patients will receive a single dose of VFI followed 160 minutes later by a single dose of 
Iohexol on Day 1.  
Patients enrolled into Cohort 3 at ICON Early Phase Services will remain resident in the CRU 
for at least 24 hours after VFI administration for safety, PK, and PD assessments. Patients will 
return to the CRU for follow-up visits on Days 4 (± 1 day), 8 (± 1 day), and 15 (± 1 day), and an 
EOS visit on Day 21 (± 1 day). 
Patients enrolled into Cohorts 3 or 4 at UAB will remain in the CRU through the 12-hour sample 
collection after VFI administration for safety, PK, and PD assessments. Patients will stay at a 
local hotel near the CRU and will return to the CRU on Day 2 for 24-hour sample collection. 
Patients will return to the CRU for follow-up visits on Days 4 (± 1 day), 8 (± 1 day), and 
15 (± 1 day), and an EOS visit on Day 21 (± 1 day). 
Refer to Table 2.1, Table 2.2, and Table 2.3 for the Schedules of Assessments and Procedures. 
Table 5.1 
Planned Dose Cohorts 
Cohort 
eGFR 
VFI Dose 
Number 
of Doses 
Comparator 
Dose 
Number 
of Doses 
Number of 
Subjects 
1* 
 60 mL/min/1.73 m2 
47 mg/3 mL 
1 
--- 
--- 
Up to 8 
2 
 60 mL/min/1.73 m2 
47 mg/3 mL 
2 
Iohexol 5 mL 
1 
Up to 8 
3 
30 and < 60 mL/min/1.73 m2 
47 mg/3 mL 
1 
Iohexol 5 mL 
1 
Up to 8 
4 
15 and < 30 mL/min/1.73 m2 
47 mg/3 mL 
1 
Iohexol 5 mL 
1 
Up to 8 

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5.1.1 
Interim Safety Data Review 
A safety review committee (SRC) will be convened at predetermined interval(s) to review safety 
data from this study. The SRC will consist of, at minimum, the investigator, medical monitor, 
and sponsor medical representative. If warranted, the committee may expand to include PK, PD, 
and other relevant subject matter experts. The SRC may request additional data including 
relevant PK and PD data, if necessary, and may recommend adequate safety measures including 
early termination of the study based on the discretion of the investigator or the criteria set forth 
in Section 6.4. However, should there be no AEs of clinical significance and no evidence of 
signals upon review of the safety data, subsequent dosing of subjects and patients will be 
permitted. 
5.1.2 
Duration of Study 
Subject participation for Cohort 1 is expected to last up to 43 days, including a screening period 
of up to 21 days and an on study period of up to 22 days (consisting of a single treatment period 
and an EOS visit). 
Subject participation for Cohort 2 is expected to last up to 44 days, including a screening period 
of up to 21 days and an on study period of up to 23 days (consisting of a single treatment period, 
follow-up visits, and an EOS visit). 
Patient participation for Cohorts 3 and 4 is expected to last up to 43 days, including a screening 
period of up to 21 days and an on study period of up to 22 days (consisting of a single treatment 
period, follow-up visits, and an EOS visit). 
5.1.3 
Definition of Study Completion 
End-of-study procedures will be performed as specified in the Schedules of Assessments and 
Procedures (Table 2.1, Table 2.2, and Table 2.3); subjects who terminate from the study early 
will have EOS procedures performed at the time of discontinuation. Subjects with ongoing 
clinically significant clinical or laboratory findings will be followed until the finding is resolved 
or medically stable; reasonable attempts will be made to follow-up with subjects. The subject’s 
participation in the study will end once all study assessments and follow-up have been 
completed. 
5.1.4 
End of Study 
The end of the study is defined as the date when the last subject has completed all study 
procedures up to and including the EOS/early termination visit as outlined in the Schedules of 
Assessments and Procedures (Table 2.1, Table 2.2, and Table 2.3). 

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6 
SELECTION AND WITHDRAWAL OF SUBJECTS 
Subjects must meet all the following criteria in order to be enrolled in the study. 
6.1 
Inclusion Criteria 
Subjects must meet all inclusion criteria to be eligible for study participation. 
All Subjects/Patients: 
1. Males or females  18 DQG 75 years of age. 
2. Females must be of non-childbearing potential (eg, postmenopausal [defined as cessation of 
regular menstrual periods for at least 1 year confirmed by follicle-stimulating hormone (FSH) 
test (21.7 to 153 units/mL)] or surgically sterile by hysterectomy, bilateral oophorectomy, or 
tubal ligation [documentation required] or be using a medically acceptable form of birth 
control [eg, a barrier method, intrauterine device, or hormonal contraception]) from screening 
until 30 days after last dose. 
3. Males who are sexually active and whose partners are females of childbearing potential must 
agree to practice abstinence or use condoms from screening through 90 days after 
administration of the last dose of study drug, and their partners must be willing to use a 
medically acceptable method of contraception (a barrier method, intrauterine device, or 
hormonal contraception) from screening through 90 days after administration of the last dose 
of study drug. 
4. Males must agree to not donate sperm from screening through 90 days after administration of 
the last dose of study drug. 
5. Subjects must be able to communicate effectively with the study personnel. 
6. Subjects must be informed of the nature and risks of the study and give written informed 
consent prior to screening. 
7. %RG\PDVVLQGH[ DQG 40.0 kg/m2DQGERG\ZHLJKW kg at screening and CRU 
admission. 
BMI = weight (kg)/(height [m])2 
Subjects with Normal Renal Function (Cohorts 1 and 2): 
8. Subjects must have an eGFR calculated using the CKD-EPI Equation (Levey et al 2009) 
 60 mL/min/1.73 m2 consistent with the National Kidney Foundation stages 1 and 2 of 
CKD. 
9. Subjects must be otherwise healthy and without clinically significant abnormalities as 
assessed by review of medical and surgical history, physical examination, vital signs 
measurement, pulse oximetry, ECG, and clinical laboratory evaluations conducted at 

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screening and CRU admission. A single repeat measurement/test may be performed, at the 
discretion of the physician, to confirm vital signs, pulse oximetry, ECG, and clinical 
laboratory tests abnormalities (ie, to confirm that a subject is eligible). 
Patients with Renal Impairment (Cohorts 3 and 4): 
10. Patients in Cohort 3 must have an eGFR calculated using the CKD-EPI Equation 
 (Levey et al 2009) 30 and < 60 mL/min/1.73 m2 consistent with the National Kidney 
Foundation stages 3a and 3b of CKD. 
11. Patients in Cohort 4 must have an eGFR calculated using the CKD-EPI Equation  
(Levey et al 2009) 15 and < 30 mL/min/1.73 m2 consistent with the National Kidney 
Foundation stage 4 of CKD. 
12. Patients may have clinical, ECG, and clinical laboratory findings consistent with their degree 
of renal dysfunction as assessed by review of medical and surgical history, physical 
examination, vital signs measurement, pulse oximetry, ECG, and clinical laboratory 
evaluations conducted at screening and CRU admission. A single repeat measurement/test 
may be performed, at the discretion of the physician, to confirm vital signs, pulse oximetry, 
ECG, and clinical laboratory tests abnormalities (ie, to confirm that a patient is eligible). 
6.2 
Exclusion Criteria 
Subjects will not be eligible for study participation if they meet any of the exclusion criteria, or 
will be discontinued at the discretion of the investigator in consultation with the medical monitor 
if they develop any of the exclusion criteria during the study. 
All Subjects/Patients: 
1. Female subject/patient is pregnant or breastfeeding. 
2. History or presence of conditions which, in the judgment of the investigator, are known to 
interfere with the distribution, metabolism, or excretion of drugs. 
3. History or presence of conditions that may place the subject at increased risk as determined 
by the investigator. 
4. History of surgery or major trauma within 12 weeks of screening, or surgery planned during 
the study. 
5. History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to 
any opioid, or any history of drug abuse or addiction within 6 months of screening. 
6. Systolic blood pressure (BP) < 90 or > 160 mmHg or diastolic BP < 50 or > 100 mmHg 
measured after the subject has been resting quietly in a supine position or in the most 
recumbent position possible for at least 5 minutes at screening or CRU admission. A single 
repeat measurement may be performed to confirm vital signs abnormalities (ie, to confirm 
that a subject is eligible). 

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7. Heart rate (HR) < 40 or > 105 beats per minute (bpm) measured on ECG after the subject has 
been resting quietly in a supine position or in the most recumbent position possible for at 
least 5 minutes at screening or CRU admission. A single repeat measurement may be 
performed to confirm ECG abnormalities (ie, to confirm that a subject is eligible). 
8. Has taken other investigational drugs or participated in any clinical study within 30 days or 
5 half-lives of the investigational drug’s PK, PD, or biological activity, whichever is longer, 
prior to first dose of study drug in this study. 
9. Prior exposure to VFI or known allergy to dextrans. 
10. History of any clinically significant allergic or negative reactions, side effects, or anaphylaxis 
to iodine, dyes, shellfish, isotopes, or dextran molecules. 
11. Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 
6 weeks prior to study participation. 
12. Positive screen for human immunodeficiency virus (HIV)-1 or HIV-2 antibodies, hepatitis B 
virus surface antigen (HBsAg), or hepatitis C virus (HCV) antibody. 
13. Diagnosis of acquired immune deficiency syndrome (AIDS).  
14. History of nephrectomy or kidney transplant. 
15. History of liver disease or screening liver function tests which exceed 2 × the upper limit of 
normal (ULN) or an albumin value of < 2.5 mg/dL. 
16. International normalized ratio (INR) > 1.5 × ULN or a platelet count < 50,000. 
17. Presence of significant hemodynamic instabilities. 
18. Loss of Limb- as this alters the validity of eGFR and estimated PV equations. 
19. Any other condition or prior therapy that, in the investigator’s opinion, would make the 
subject unsuitable for the study, or unable or unwilling to comply with the study procedures. 
20. Involved in the planning or conduct of this study. 
21. Inability to tolerate venipuncture or poor venous access. 
22. Unwilling to abstain from alcohol from 24 hours prior to admission until discharge from the 
CRU. 
23. Unwilling to abstain from strenuous activity (as assessed by the investigator) from 72 hours 
prior to admission until discharge from the CRU. 
24. Unwilling or unlikely to comply with the requirements of the study. 

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25. Use of over the-counter (OTC) drugs (including herbal preparations) within 3 days or 
5 half-lives, whichever is longer, prior to administration of the first dose of study drug. 
26. Use of nonsteriodal anti-inflammatory drugs within 3 days or 5 half-lives prior to 
administration of the study drug. 
Subjects with Normal Renal Function (Cohorts 1 and 2): 
27. Positive urine drugs of abuse or serum alcohol screen. 
Patients with Renal Impairment (Cohorts 3 and 4): 
28. Clinically significant ongoing bleeding, changing hemoglobin, or experienced significant 
blood loss within 2 weeks prior to administration of the first dose of study drug. 
29. Positive urine drugs of abuse (except for prescribed medications) or serum alcohol screen. 
30. Use of inotropes or vasopressors. 
31. Any other condition or prior therapy that, in the investigator’s opinion, is likely to 
deteriorate. 
6.3 
Subject Withdrawal 
Subjects are free to discontinue the study at any time, for any reason, and without prejudice to 
further treatment. The investigator may remove a subject if, in the investigator’s judgment, 
continued participation would pose unacceptable risk to the subject or to the integrity of the 
study data. All procedures for early termination must be completed. Reasons for removal or 
withdrawal may include: 
x Withdrawal of consent 
x Administrative decision by the investigator or sponsor 
x Ineligibility 
x Significant protocol deviation 
x Subject noncompliance 
x Safety concern by the investigator or sponsor 
x Lost to follow-up 
Subjects who are withdrawn for reasons other than safety issues may be replaced at the 
discretion of the sponsor and investigator. 
In the event of a subject’s withdrawal, the investigator will promptly notify the medical monitor 
and will make every effort to complete the EOS assessments. All withdrawn subjects with 
ongoing clinically significant clinical or laboratory findings will be followed until the finding is 
resolved or medically stable; reasonable attempts will be made to follow-up with subjects. 

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Subjects will be withdrawn from the study if they meet specific stopping criteria for the study 
(see Section 6.4). 
6.4 
Early Termination of Study 
6.4.1 
Cohort Stopping Criteria 
Dosing in a cohort will be suspended if any of the following occur: 
x 2 or more subjects in the dose cohort meet individual stopping criteria (Table 6.1) 
x 2 or more subjects in the dose cohort experience treatment-related clinically relevant 
(ie, moderate and/or severe) AEs 
x 1 or more subjects in the dose cohort experience a treatment-related SAE 
6.4.2 
Individual Subject Stopping Criteria 
The individual subject stopping criteria are presented in Table 6.1. 
Table 6.1 
Individual Stopping Criteria 
Clinical Laboratory Parameter 
Stopping Criteria 
AST 
> 5 × ULN 
ALT 
> 5 × ULN 
Increase of Scr 
> 1.5 × baseline; > 1.5 × ULN 
Subjects who have met one of the stopping criteria will continue with follow-up visits and 
PK/PD sampling unless the investigator or subject decides not to proceed. 
Dosing of a cohort may be suspended on lesser changes in these parameters or change in other 
laboratory parameters at the discretion of the SRC. 

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7 
TREATMENT OF SUBJECTS 
7.1 
Identity of Investigational Product 
The identity of the investigational product is presented in Table 7.1. 
Table 7.1 
Investigational Product 
Investigational Product 
Dosage Form 
Strength 
Dose 
Visible Fluorescent Injectate 
Solution for injection 
35mg FD001/12mg FD003 
47 mg/3 mL 
VFI will be sourced by FAST BioMedical. The VFI is packaged in a 10-mL, 20-mm clear glass 
vial with a 20-mm gray stopper and blue cap, and the product is a deeply colored lyophilized 
cake. 
7.2 
Identity of Comparator Products 
The identity of the comparator products is presented in Table 7.2. 
Table 7.2 
Comparator Products 
Comparator Product 
Dosage Form 
Strength 
Dose 
Omnipaque 300 (Iohexol) 
Solution for injection 
647 mg of Iohexol equivalent to 
300 mg of organic iodine per mL 
5 mL 
Comparator products will be sourced by the CRU. 
Iohexol is packaged in a clear 10 mL bottle with a brown cap, and the product is a colorless to 
pale-yellow liquid. Each mL of Iohexol solution contains 1.21 mg tromethamine and 0.1 mg 
edetate calcium disodium. 
7.3 
Treatments Administered 
Each subject will receive at least a single dose of the VFI, which will be administered IV through 
a bolus injection. Subjects in Cohort 1 will receive an infusion of 5% albumin (up to a maximum 
volume of 7 mL/kg over 30 minutes) 130 minutes after the dose of VFI in order to measure the 
increase in the subject’s plasma volume using the FAST PV Technology. 
An IV catheter will be inserted into the subject’s arm. A single dose of VFI 47 mg/3 mL will be 
administered as a bolus injection through the catheter. A single dose of Iohexol 5 mL will be 
administered as a bolus injection through the same catheter 160 minutes after administration of 
VFI in Cohorts 2 through 4. Subjects in Cohort 2 will receive a second dose of VFI 47 mg/3 mL 
bolus injection 24 hours after the initial dose of VFI in order to assess the repeatability of the 
FAST mGFR Technology. 
For safety reasons, the first 2 subjects in Cohort 2 will receive their second dose of VFI at least 
24 hours before VFI dosing in the remaining subjects. Administration of VFI will be performed 
in a sequential manner with at least 60 minutes between each subject. 

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A low-protein snack will be served prior to administration of the VFI (eg, toast, bagel or 
primarily carbohydrate based small portion). Water will be allowed as desired. 
Standard meals will be served for Cohorts 1 and 2. Meals appropriate for the patient’s medical 
condition will be served for Cohorts 3 and 4. 
7.4 
Method of Assigning Subjects to Treatment Groups 
Eligible subjects/patients will be enrolled in a cohort based on renal function and will be 
assigned sequential subject numbers. 
7.5 
Measurements of Treatment Compliance 
Investigational product will be administered by qualified healthcare professionals at the CRU as 
designated by the investigator. Details regarding dosing, including the dose administered and the 
date and time of dosing, will be recorded. The prepared syringes to be used for VFI and Iohexol 
injections will be weighed and documented before and after dosing in order to calculate the exact 
amount of product administered.  
7.6 
Investigational Product Storage, Accountability, and Retention 
7.6.1 
Storage Conditions 
The VFI will be stored in a refrigerator at 2 to 8°C (36 to 46°F). Vials and glass or polymer 
bottles of Iohexol will be protected from strong daylight and direct exposure to sunlight and will 
be stored at controlled room temperature at 20 to 25°C (68 to 77°F); excursions are permitted to 
15 to 30°C (59 to 86°F). 
The VFI will be prepared within 60 minutes of dosing, and the prepared product will be stored at 
room temperature (25°C). The product will be protected from sunlight and ultraviolet light until 
dosing. The procedure for VFI preparation is located in Appendix A. 
Iohexol will be drawn into a syringe for administration and stored at room temperature (25°C). 
The investigator will ensure that all the study drugs are stored and dispensed in accordance with 
Food and Drug Administration (FDA) regulations concerning the storage and administration of 
investigational drugs. 
7.6.2 
Drug Preparation 
The procedure for reconstitution of the FAST VFI is located in Appendix A. 
7.7 
Packaging and Labeling 
7.7.1 
Study Drug 
The study drugs will be provided with appropriate labeling, including: sponsor name, address, 
and phone number, product name, active constituents, content by volume and number of units, 
batch number, expiry date, storage instructions, and the term “Caution: Investigational New 
Drug Limited by US Federal Law for Investigational Use Only.” 

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7.7.2 
Blinding of Treatment Assignment 
Not applicable. This is an open-label study. 
7.8 
Concomitant Medications and Other Restrictions 
7.8.1 
Concomitant Medications 
For subjects in Cohorts 1 and 2, no concomitant medications (prescription, OTC, and herbal) 
may be administered, other than hormonal birth control, during the study unless they are 
prescribed by the investigator for treatment of specific clinical events (ie, AEs). However, for 
patients in Cohorts 3 and 4, maintenance medications as prescribed by their physicians are 
permitted. All medications (prescription and OTC), vitamin and mineral supplements, and herbs 
taken during the study will be documented on the concomitant medication electronic case report 
form (eCRF). Information recorded will include: start and stop dates and times, dose and route of 
administration, and indication. Medications taken for a procedure should also be included. 
7.8.2 
Other Restrictions 
Subjects will be instructed to adhere to the following restrictions: 
x Strenuous activity (as assessed by the investigator) is prohibited from 72 hours prior to 
admission until discharge from the CRU. 
x Subjects are not permitted to consume alcohol from 24 hours prior to admission until 
discharge from the CRU. 
x Subjects are not permitted to consume any food and drink from outside of the CRU while 
residing at the CRU. 
x Subjects must comply with the CRU smoking policy, if applicable. 
x Subjects are not permitted to participate in any other clinical trial or donate blood or plasma 
while participating in this clinical trial. 

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8 
STUDY ASSESSMENTS AND PROCEDURES 
Subjects will undergo study procedures and assessments at time points specified in the Schedules 
of Assessments and Procedures (Table 2.1, Table 2.2, and Table 2.3). 
8.1 
Medical and Surgical History 
The investigator or designee will collect a complete medical and surgical history at screening. 
Interim medical and surgical history will be collected at CRU admission to determine if any 
changes have occurred since screening. The medical history should include all active medical 
problems regardless of time of onset. 
8.2 
Demographic Characteristics 
Demographic characteristics including sex, age, race, and ethnicity will be recorded. 
8.3 
Physical Measurements 
Height (cm) and body weight (kg) without shoes will be recorded. Body mass index will be 
calculated using the height obtained at screening. 
8.4 
Pharmacokinetic Assessments 
8.4.1 
Drug Concentration Measurements 
Plasma PK samples will be collected at time points specified in the PK and PD Sampling 
Schedules (Table 2.4, Table 2.5, and Table 2.6). Blood sample collection, processing, and 
shipping details will be outlined in a separate study reference manual. 
Plasma concentrations of FD001 and FD0003 will be determined using a validated fluorometric 
assay at MRIGlobal. 
Urine concentrations of FD001 will be determined using a validated method and concentration of 
FD001 will be multiplied by urine volume to determine the amount of excreted FD001. 
8.4.2 
Pharmacokinetic Parameters 
Pharmacokinetic parameters will be calculated from the plasma and urine concentration data 
using noncompartmental methods (Phoenix WinNonlin, Version 6.3 or later, Pharsight 
Corporation, St. Louis, MO) and actual sampling times. The following PK parameters will be 
determined: 
Cmax 
Maximum observed plasma concentration 
tmax 
The time that Cmax was observed 
AUC0-12 
Area under the plasma concentration-time curve from time 0 to 12 hours; 
calculated using the linear/log trapezoidal rule (FD001 only) 

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AUClast 
Area under the plasma concentration-time curve from time 0 to the time of the 
last quantifiable concentration; calculated using the linear/log trapezoidal rule 
AUCinf 
Area under the plasma concentration-time curve from time 0 extrapolated to 
infinity; calculated as AUClast + Clast/Oz, where Clast is the last measurable 
concentration 
AUCextrap 
Area under the plasma concentration-time curve from the time of last observed 
concentration extrapolated to infinity expressed as a percent 
t½ 
Terminal elimination half-life; calculated as ln(2)/Oz 
Ȝz 
Terminal elimination rate constant 
CL 
Total body clearance; calculated as Dose/AUCinf 
CLr0-2 
Renal clearance from time 0 to 2 hours; calculated as Ae0-2/AUC0-2, where Ae0-2 
is the amount of FD001 excreted in the urine from time 0 to 2 hours 
(FD001 only) 
CLr2-12 
Renal clearance from time 2 to 12 hours; calculated as Ae2-12/AUC2-12, where 
Ae2-12 is the amount of FD001 excreted in the urine from time 2 to 12 hours 
(FD001 only) 
CLr0-12 
Renal clearance from time 0 to 12 hours; calculated as Ae0-12/AUC0-12, where 
Ae0-12 is the amount of FD001 excreted in the urine from time 0 to 12 hours 
(FD001 only) 
Vz 
Volume of distribution during the terminal phaseFDOFXODWHGDV&/Ȝz 
Vss 
Volume of distribution at steady state; calculated as MRTinf × CL, where 
MRTinf is the mean residence time extrapolated to infinity 
Ae0-2 
Amount of FD001 excreted unchanged in the urine from time 0 to 2 hours 
Ae2-12 
Amount of FD001 excreted unchanged in the urine from time 2 to 12 hours 
Ae0-12 
Amount of FD001 excreted unchanged in urine from time 0 to 12 hours 

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Extrapolation methods will be used in Cohort 2, as needed, to correct concentration data after a 
second dose of FAST VFI in order to calculate PK parameters. Alternative methods (ie, 
compartmental modeling) may be used if extrapolation methods are inadequate. Computational 
details will be provided in a separate statistical analysis plan (SAP). 
For the calculation of the FAST mGFR and PV in Cohort 2, residual levels of FD003 will be 
measured in the predose sample and those values subtracted from post-second-administration 
sample values to allow for a clean calculation of PV from dose 2. As these are healthy subjects 
we are not anticipating any level of residual FD001 that would affect the calculation of GFR. 
8.5 
Pharmacodynamic Assessments 
Plasma PD samples for determination of PV and GFR will be collected at time points specified 
in the PK and PD Sampling Schedules (Table 2.4, Table 2.5, and Table 2.6). Blood sample 
collection, processing, and shipping details will be outlined in a separate study reference manual. 
Additional PD assessments will be performed at time points specified in the Schedules of 
Assessments and Procedures (Table 2.1, Table 2.2, and Table 2.3). 
8.5.1 
Pharmacodynamic Parameters 
8.5.1.1 
Plasma Volume 
Plasma volume will be determined using FAST PV Technology for Cohorts 1 through 4. 
Additionally, PV will be estimated using Nadler’s formula (Nadler et al 1962) for Cohorts 1 
through 4. Nadler’s formula (Nadler et al 1962) is as follows: 
Plasma Volume (males) = 0.3669 × (Height [m])3 + 0.03219 × (Body Weight [kg]) + 0.6041 
Plasma Volume (females) = 0.3561 × (Height [m])3 + 0.03308 × (Body Weight [kg]) + 0.1833 
8.5.1.2 
Glomerular Filtration Rate 
Measured GFR will be determined using FAST mGFR Technology for Cohorts 1 through 4. 
Glomerular filtration rate will also be determined using the Iohexol clearance test, a widely 
accepted research gold standard for measuring GFR in patients with stable renal function, for 
Cohorts 2 through 4. Plasma concentrations of Iohexol will be determined using a validated high 
performance liquid chromatography assay. 
Additionally, eGFR will be calculated using the MDRD (Levey et al 1999), CKD-EPI (Levey et 
al 2009) and Cockcroft-Gault (Cockcroft et al 1976) equations for Cohorts 1 through 4. 

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The MDRD equation (Levey et al 1999) is as follows: 
GFR (mL/min/1.73 m2) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African 
American) 
The CKD-EPI equation (Levey et al 2009) for eGFR for specified race, sex, and Scr in mg/dL 
and μmol/L is presented in Table 8.1 and Table 8.2, respectively. 
The Cockcroft-Gault equation (Botev et al 2009) is as follows: 
GFR = [(140-Age) x (Weight) x 0.85 if female]/72 x SCr 
 
Table 8.1 
Chronic Kidney Disease Epidemiology Collaboration Equation for 
Estimating Glomerular Filtration Rate Expressed for Specified Race, Sex, 
and Serum Creatinine (mg/dL) 
Race 
Sex 
Scr (mg/dL) 
(TXDWLRQDJHLQ\HDUVIRU 
Black 
Female 
 
GFR = 166 × (Scr/0.7)-0.329 × (0.993)Age 
Black 
Female 
> 0.7 
GFR = 166 × (Scr/0.7)-1.209 × (0.993)Age 
Black 
Male 
 
GFR = 163 × (Scr/0.9)-0.411 × (0.993)Age 
Black 
Male 
> 0.9 
GFR = 163 × (Scr/0.9)-1.209 × (0.993)Age 
White or other 
Female 
 
GFR = 144 × (Scr/0.7)-0.329 × (0.993)Age 
White or other 
Female 
> 0.7 
GFR = 144 × (Scr/0.7)-1.209 × (0.993)Age 
White or other 
Male 
 
GFR = 141 × (Scr/0.9)-0.411 × (0.993)Age 
White or other 
Male 
> 0.9 
GFR = 141 × (Scr/0.9)-1.209 × (0.993)Age 
Source: National Institute of Diabetes and Digestive and Kidney Diseases, Estimating Glomerular Filtration Rate 
(2015) 
 
Table 8.2 
Chronic Kidney Disease Epidemiology Collaboration Equation for 
Estimating Glomerular Filtration Rate Expressed for Specified Race, Sex, 
and Serum Creatinine (μmol/L) 
Race 
Sex 
Scr (μmol/L) 
Equation (age in \HDUVIRU 
Black 
Female 
 
GFR = 166 × (Scr/61.9)-0.329 × (0.993)Age 
Black 
Female 
> 61.9 
GFR = 166 × (Scr/61.9)-1.209 × (0.993)Age 
Black 
Male 
 
GFR = 163 × (Scr/79.6)-0.411 × (0.993)Age 
Black 
Male 
> 79.6 
GFR = 163 × (Scr/79.6)-1.209 × (0.993)Age 
White or other 
Female 
 
GFR = 144 × (Scr/61.9)-0.329 × (0.993)Age 
White or other 
Female 
> 61.9 
GFR = 144 × (Scr/61.9)-1.209 × (0.993)Age 
White or other 
Male 
 
GFR = 141 × (Scr/79.6)-0.411 × (0.993)Age 
White or other 
Male 
> 79.6 
GFR = 141 × (Scr/79.6)-1.209 × (0.993)Age 
Source: National Institute of Diabetes and Digestive and Kidney Diseases, Estimating Glomerular Filtration Rate 
(2015) 

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8.6 
Safety Assessments 
8.6.1 
Adverse Events 
Subjects will be monitored for AEs from administration of the first dose of study drug through 
the EOS visit. Refer to Section 9 for additional details. 
8.6.2 
Clinical Laboratory Tests 
A certified laboratory will be utilized to process and provide results for the clinical laboratory 
tests listed in Table 8.3. The baseline laboratory test results for clinical assessment for a 
particular test will be defined as the last measurement prior to the initial dose of study drug. 
During the screening period, if a subject has an out-of-range value for a clinical laboratory 
parameter which the investigator believes is not clinically significant, but the investigator wants 
to confirm with a repeat laboratory test, a single repeat is allowed to confirm the initial result. 
Table 8.3 
Clinical Laboratory Tests 
Hematology 
Coagulation 
Serum Chemistry 
Urinalysisa,b,e 
Hematocrit 
Hemoglobin 
Red blood cell count 
Mean corpuscular volume 
White blood cell count 
Platelet count (estimate not 
acceptable) 
Neutrophils (absolute) 
Eosinophils (absolute) 
Basophils (absolute) 
Lymphocytes (absolute) 
Monocytes (absolute) 
INRc 
Sodium 
Potassium 
Chloride 
Albumin 
Aspartate aminotransferase 
Alanine aminotransferase 
Alkaline phosphatase 
Creatine phosphokinase 
Glucosed 
Total cholesterold 
BUN 
Creatinine 
Total bilirubin 
Calcium 
Total protein 
Phosphorous 
Nitrites 
Leukocytes 
Protein 
Glucose 
Ketones 
Urobilinogen 
Bilirubin 
Blood 
pH 
Specific gravity 
a. 
In case of clinically significant findings, a microscopic analysis will be performed. 
b. If 1+ or greater protein is noted in the urinalysis, a calculated urine protein to creatinine ratio will be performed. 
c. 
Cohorts 3 and 4 only. 
d. Should be collected after fasting for a minimum of 8 hours. 
e. 
A urine protein to creatinine ratio will be performed only at predose on testing day and 24 hours postdose. 
Subjects will be fasting prior to this measurement. 
For any laboratory test value outside the reference range that the investigator considers clinically 
significant during the on-study period (ie, following dose administration), the investigator will: 
x Repeat the test to verify the out-of-range value and clinical significance. 

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x Follow the out-of-range value to a satisfactory clinical resolution. 
x Record as an AE any laboratory test value that (1) is confirmed by repeat and the investigator 
considers clinically significant, (2) requires a subject to be discontinued from the study, 
(3) requires a subject to receive treatment, or (4) requires a change or discontinuation of the 
study drug (if applicable). 
8.6.3 
Other Tests 
The following tests will be performed: 
x Urine drugs of abuse (at a minimum, cocaine, cannabinoids, amphetamines, opiates, 
barbiturates, benzodiazepines, and phencyclidine [ICON site only) and serum alcohol screens 
x Serology tests (ie, HIV-1 and HIV-2 antibodies, HBsAg, and HCV antibody) 
x Follicle-stimulating hormone (females only; as needed to confirm postmenopausal status) 
x Pregnancy Test (females only) 
During the screening period, urine drugs of abuse and serum alcohol screens may not be repeated 
for eligibility. 
8.6.4 
Vital Signs 
Vital signs assessments will include oral temperature (°C), respiratory rate (breaths per minute), 
systolic and diastolic BP (mmHg) and pulse rate (bpm). Blood pressure and pulse rate will be 
measured after the subject has been resting quietly in a supine position or in the most recumbent 
position possible for at least 5 minutes. 
Vital signs abnormalities that (1) are considered clinically significant initially and on 
confirmation, (2) require a subject to be discontinued from the study, (3) require a subject to 
receive treatment, or (4) require a change or discontinuation from the study drug (if applicable) 
will be recorded as AEs. 
8.6.5 
Pulse Oximetry 
Oxygen saturation will be measured by pulse oximetry. 
Oxygen saturation abnormalities that (1) are considered clinically significant initially and on 
confirmation, (2) require a subject to be discontinued from the study, (3) require a subject to 
receive treatment, or (4) require a change or discontinuation from the study drug (if applicable) 
will be recorded as AEs. 
8.6.6 
Physical Examination 
Complete physical examinations (including eyes, ears, nose and throat, cardiac, peripheral 
vascular, pulmonary, musculoskeletal, neurologic, abdominal, lymphatic, and dermatologic 
systems) will be performed, and abnormal findings will be carefully documented in the subject’s 
eCRF. 

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An abnormal physical examination finding that is considered clinically significant and 
(1) requires the subject to be discontinued from the study, (2) requires the subject to receive 
treatment, or (3) requires a change or discontinuation of the study drug (if applicable) will be 
recorded as an AE. 
8.6.7 
Electrocardiograms 
Subjects must be resting quietly in a supine position or in the most recumbent position possible 
for at least 5 minutes before the ECG is obtained. The following ECG parameters will be 
recorded: HR, RR, PR, QRS, and QT and QT interval corrected for HR using Fridericia’s 
formula (QTcF) intervals. 
Electrocardiogram assessment will include interpretation of the tracings, eg, rhythm, presence of 
arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or 
ST segment, T-wave, and U-wave abnormalities. The investigator or designee is responsible for 
reviewing and over-reading the ECG interpretation, for assessing whether the ECG machine 
interpretation findings are accurate, appropriate, normal or abnormal, and for providing corrected 
interpretations as appropriate. In addition, any abnormal ECGs will be assessed for clinical 
significance. 
Additional ECGs may be obtained if clinically indicated. Any additional relevant data obtained 
by the investigator during the course of this study will be supplied to the sponsor. 
For any ECG that the investigator considers clinically significant, the investigator will: 
x Repeat the ECG. 
x Follow-up ECG(s) will be obtained if any significant abnormalities are detected after dose 
administration to document resolution and as clinically indicated.  
x Record as an AE any ECG that (1) is confirmed and the investigator considers clinically 
significant, (2) requires a subject to be discontinued from the study, (3) requires a subject to 
receive treatment, or (4) requires a change or discontinuation of the study drug (if 
applicable). 
8.6.8 
Appropriateness of Safety Assessments 
Safety evaluations selected for this study are typical of those for this subject population and 
utilize widely accepted measures. 
A crash cart containing epinephrine will be available for each dosing event throughout the study. 

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9 
ADVERSE EVENTS 
An AE is defined as any untoward medical occurrence in a subject administered a 
pharmaceutical product during the course of a clinical investigation. An AE can therefore be any 
unfavorable and unintended sign, symptom, or disease temporally associated with the use of an 
investigational product, whether or not thought to be related to the investigational product. 
Subjects will be monitored throughout the study for AEs, from administration of the first dose of 
study drug through the EOS visit. Adverse events that are identified at the last assessment visit 
(or the early termination visit) as specified in the protocol must be recorded on the AE eCRF 
with the status of the AE noted. All events that are ongoing at this time will be recorded as 
ongoing on the eCRF. All (both serious and nonserious) AEs must be followed until they are 
resolved or stabilized, or until attempts to determine resolution of the event are exhausted. The 
investigator should use his/her discretion in ordering additional tests as necessary to monitor the 
resolution of such events. 
The procedures specified in Section 9.4 are to be followed for reporting SAEs. 
9.1 
Recording Adverse Events 
Adverse events are to be recorded on the AE page of the eCRF. The following information will 
be recorded: 
x Assessment of whether or not the AE is a SAE (Section 9.2.1) 
x Assessment of AE intensity (Section 9.2.2) 
x Assessment of AE relationship to study drug (Section 9.2.3) 
x Action taken - categorized as none, study drug discontinued, dose modified, required 
concomitant medication, required procedure, or other 
x Outcome - recorded as event resolved, resolved with sequelae, ongoing, or death 
9.2 
Assessment of Adverse Events 
The investigator will assess each AE for seriousness, intensity, and relationship to study drug. 

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9.2.1 
Serious Adverse Events 
The investigator is responsible for determining whether an AE meets the definition of a SAE. A 
SAE is any AE occurring from ICF signing through the EOS visit that results in any of the 
following outcomes: 
x Death 
x A life-threatening adverse drug experience 
x Inpatient hospitalization or prolongation of existing hospitalization 
x A persistent or significant disability/incapacity 
x A congenital anomaly/birth defect 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered a SAE when, based upon appropriate medical judgment, they 
may jeopardize the subject and may require medical or surgical intervention to prevent any of the 
outcomes listed in this definition. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias 
or convulsions that do not result in inpatient hospitalization, or the development of drug 
dependency or drug abuse. 
Note: SAEs require immediate reporting to the medical monitor. Refer to “Reporting Serious 
Adverse Events” (Section 9.4) for details. 
9.2.2 
Intensity 
The intensity of an AE will be graded according to the following definitions: 
x Mild: Any symptom of which the subject is aware, but which is easily tolerated; 
asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not 
indicated. 
x Moderate: Any symptom which is discomforting enough to cause interference with a 
subject's usual activity; minimal, local, or noninvasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living (ADL). 
x Severe: Any symptom which causes a subject's inability to perform usual activity; severe or 
medically significant but not immediately life-threatening; hospitalization or prolongation of 
hospitalization indicated; disabling; limiting self-care ADL. 

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9.2.3 
Relationship to Study Drug 
The relationship of an AE to the study drug should be determined by the investigator according 
to the following criteria: 
x Not related: The event is most likely produced by other factors such as the subject’s clinical 
condition, intercurrent illness, or concomitant drugs, and does not follow a known response 
pattern to the study drug, or the temporal relationship of the event to study drug 
administration makes a causal relationship unlikely 
x Possibly related: The event follows a reasonable temporal sequence from the time of drug 
administration, and/or follows a known response pattern to the study drug, but could have 
been produced by other factors such as the subject's clinical condition, intercurrent illness, or 
concomitant drugs 
x Probably related: The event follows a reasonable temporal sequence from the time of drug 
administration, and/or follows a known response pattern to the study drug, and cannot be 
reasonably explained by other factors such as the subject's clinical condition, intercurrent 
illness, or concomitant drugs 
9.2.4 
Significant Adverse Events 
Significant AEs are defined as marked hematological and other laboratory abnormalities (other 
than those meeting the definition of serious) and any events that led to an intervention, including 
withdrawal of study drug, dose reduction, or significant additional concomitant therapy, other 
than those reported as SAEs. 
9.3 
Discontinuation due to Adverse Events 
Any subject who experiences an AE may be withdrawn at any time from the study at the 
discretion of the investigator. Subjects withdrawn from the study due to an AE, whether serious 
or nonserious, may be followed by the investigator until the clinical outcome of the AE is 
determined. The AE(s) should be noted on the appropriate eCRFs and the subject’s progress 
should be followed until the AE is resolved or stabilized as determined by the investigator. The 
medical monitor must be notified. If the AE relates to overdose of study treatment, the 
Investigator’s Brochure should be consulted for details of any specific actions to be taken. 
9.4 
Reporting Serious Adverse Events 
In the event of any SAE reported or observed during the study, whether or not attributable to the 
study drug, site personnel will report it immediately by telephone to the medical monitor AND to 
the SAE hotline at ICON in accordance with procedures described in the study reference manual 
and/or SAE study-specific procedure. Site personnel will follow up with a faxed written report 
on the next working day as follows. 

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ICON SAE Hotline Telephone: (888) 723-9952 
This telephone report must be followed within 24 hours by a FAX transmission of a 
completed SAE Report Form to the number indicated below: 
Fax: (215) 616-3096 
SAE Report Forms will be provided to the investigational site to assist in collecting, organizing, 
and reporting SAEs and follow-up information. 
All SAEs should be followed to their resolution, with documentation provided to ICON on a 
follow-up SAE Report Form. 
9.5 
Pregnancy 
The investigator must report any pregnancy to the medical monitor and to the ICON Medical and 
Safety Service within 1 business day of becoming aware of the pregnancy per pregnancy 
reporting procedures described in the study reference manual. An uncomplicated pregnancy will 
not be considered an AE or SAE; however, all pregnancies will be followed through birth and 
3 months postdelivery. 
Pregnancies in the sexual partners of male subjects will be captured from the time the subject is 
first exposed to the investigational product until 90 days after last exposure to the investigational 
product. 
Any congenital abnormalities in the offspring of a subject who received study drug will be 
reported as a SAE. The outcome of any pregnancy and the presence or absence of any congenital 
abnormality will be recorded in the source documentation and reported to the medical monitor 
and sponsor. 
9.6 
Drug-induced Liver Injury 
Subjects will be monitored for signs of drug-induced liver injury (DILI). Study drug will be 
withheld in the event of potential DILI. 
Potential events of DILI will be defined as meeting all of the following criteria (as specified in 
the FDA Guidance for Industry Drug-induced Liver Injury: Premarketing Clinical Evaluation, 
2009): 
x Alanine aminotransferase or aspartate aminotransferase > 3 × ULN 
x Total bilirubin > 2 × ULN without initial findings of cholestasis (elevated serum alkaline 
phosphatase) 
x No other reason can be found to explain the combination of laboratory value increases 
(eg, acute viral hepatitis; alcoholic and autoimmune hepatitis; hepatobiliary disorders; 
nonalcoholic steatohepatitis; cardiovascular causes; concomitant treatments) 

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Potential events of DILI will be reported as SAEs (Section 9.4). All subjects with potential DILI 
will be closely followed until abnormalities return to normal or baseline or until all attempts to 
determine resolution of the event are exhausted. 

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10 
STATISTICAL CONSIDERATIONS 
The statistical analysis will be conducted following the principles as specified in International 
Council for Harmonisation (ICH) Topic E9 (CPMP/ICH/363/96). 
All statistical analyses will be described in a separate SAP. 
10.1 
Sample Size Calculation 
Approximately 32 subjects/patients will be enrolled in 4 cohorts consisting of up to 
8 subjects/patients each. 
The sample size in this study is representative of Phase 2b studies of this type. Power 
calculations were not used to derive the sample size. 
10.2 
Analysis Populations 
Pharmacokinetic Full Population: All subjects in Cohorts 2 through 4 who receive a known 
amount of study drug and have at least one quantifiable concentration of FD001 or FD003 in 
plasma or FD001 in urine and subjects in Cohort 1 who receive a known amount of study drug. 
Plasma concentrations for subjects in Cohort 1 will not contribute to the overall PK statistical 
analysis and will be analyzed for CLr, Cmax, and using the FAST mGFR and PV measurement 
calculations only. 
Pharmacokinetic Evaluable Population: All subjects in Cohorts 1 through 4 who receive a known 
amount of study drug and have at least 1 estimable PK parameter. 
Safety Population: All subjects who received any amount of study drug. 
Pharmacodynamic Evaluable Population: All subjects in Cohorts 1 through 4 who have either a 
PV or GFR estimate using any of the techniques under study. Subjects in Cohort 1 will not 
contribute to the overall PD statistical analysis. 

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10.3 
Endpoints 
10.3.1 
Primary Endpoints 
10.3.1.1 
Safety 
x AEs and SAEs 
x Clinical laboratory tests, physical examination findings, 12-lead EGs, and vital signs 
including pulse oximetry 
10.3.1.2 
Pharmcokinetics 
x Cmax 
x tmax 
x AUC0-12 (FD001 only) 
x AUClast 
x AUCinf 
x t½ 
x Ȝz 
x CL 
x CLr0-2 (FD001 only) 
x CLr2-12 (FD001 only) 
x CLr0 12 (FD001 only) 
x Vz 
x Vss 
x Ae0-2 
x Ae2-12 
x Ae0-12 
10.3.2 
Secondary Endpoints 
10.3.2.1 
Pharmacodynamic 
x PV as assessed by FAST PV and mGFR Technology 
x PV as assessed by Nadler’s formula 
x Assess changes in PV after fluid challenge 
x Assess repeatability of GFR measurements over 24 hours 
x mGFR as assessed by FAST VFI and Iohexol clearance methods 

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x eGFR (calculated by MDRD, CKD-EPI, and Cockcroft-Gault equations) 
10.4 
Pharmacokinetic Statistical Analysis 
For Cohorts 2 through 4, subject plasma concentration-time profiles will be listed and 
summarized for each analyte by nominal sampling time. Summary statistics will be listed and 
summarized for each PK parameter by cohort and analyte. Plasma concentrations for subjects in 
Cohort 1 will not contribute to the overall PK statistical analysis and will be analyzed for CLr, 
Cmax, and using the FAST mGFR and PV measurement calculations only. 
10.5 
Pharmacodynamic Statistical Analysis 
10.5.1 
Plasma Volume 
The FAST PV Technology for determining PV will be compared to PV estimated using Nadler's 
formula. Plasma volume data will be listed and summarized by presenting descriptive statistics 
of raw data. The correlation as well as the associated plot will be presented for comparing PV 
between methods. Cosgriff et al. 1999 shows that a combination of the correlation and a 
histogram of the magnitude of difference is needed when no measured comparator is available. 
10.5.2 
Glomerular Filtration Rate 
Measured GFR determined using the FAST VFI Technology will be compared to the mGFR 
determined using the Iohexol clearance test for Cohorts 2 through 4 only. The results will be 
listed by subject and summarized by presenting descriptive statistics for each cohort. Correlation 
analysis and Bland-Altman plots will be used to compare the FAST mGFR with Iohexol 
clearance. 
Estimated GFR calculated using the MDRD, CKD-EPI, and Cockcroft-Gault equations will be 
listed by subject and summarized by presenting descriptive statistics for each cohort (Cohorts 1 
through 4). 
10.6 
Safety Analysis 
Electrocardiogram, vital signs, pulse oximetry, and clinical laboratory test data (observed and 
change from baseline) will be summarized by cohort, time point, and treatment using appropriate 
descriptive statistics. Physical examination findings will be listed only. 
The number and percentage of subjects reporting any TEAE will be tabulated by system organ 
class and preferred term, cohort, and treatment (coded using Medical Dictionary for Regulatory 
Activities). Treatment-emergent AEs will be further classified by severity and relationship to 
treatment. 

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ACCESS TO SOURCE DATA/DOCUMENTS 
The investigator will provide direct access to source data and documents for individuals 
conducting study-related monitoring, audits, Institutional Review Board/Independent Ethics 
Committee (IRB/IEC) review, and regulatory review. The investigator must inform the study 
subject that his/her study-related records may be reviewed by the above individuals without 
violating the subject’s privacy of personal health information in compliance with Health 
Insurance Portability and Accountability Act of 1996 (HIPAA) regulations. 
Attention is drawn to the regulations promulgated by the FDA under the Freedom of Information 
Act providing, in part, that information furnished to clinical investigators and IRBs will be kept 
confidential by the FDA only if maintained in confidence by the clinical investigator and IRB. 
By signing this protocol, the investigator affirms to the sponsor that the investigator will 
maintain, in confidence, information furnished to him or her by the sponsor and will divulge 
such information to the IRB under an appropriate understanding of confidentiality with such 
board. 

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QUALITY CONTROL AND QUALITY ASSURANCE 
FAST BioMedical/ICON will implement and maintain quality control and quality assurance 
procedures with written standard operating procedures to ensure the study is conducted and data 
are generated, documented, and reported in compliance with the protocol, GCP, and applicable 
regulatory requirements. 
12.1 
Conduct of Study 
This study will be conducted in accordance with the FDA Code of Federal Regulations (CFR 
§312.50 and §312.56) and the ICH E6 Guidelines on good clinical practice (CPMP/ICH/135/95). 
Specifically, this study is based on adequately performed laboratory and animal experimentation; 
the study will be conducted under a protocol reviewed by an IRB or IEC; the study will be 
conducted by scientifically and medically qualified persons; the benefits of the study are in 
proportion to the risks; the rights and welfare of the subjects will be respected; the physicians 
conducting the study do not find the hazards to outweigh the potential benefits; and each subject 
will give his or her written, informed consent before any protocol-driven tests or evaluations are 
performed. 
The investigator may not deviate from the protocol without a formal protocol amendment having 
been established and approved by an appropriate IRB/IEC, except when necessary to eliminate 
immediate hazards to the subject or when the change(s) involve only logistical or administrative 
aspects of the study and are approved by the medical monitor and/or FAST BioMedical. Any 
deviation may result in the subject having to be withdrawn from the study, and may render that 
subject nonevaluable. 
12.1.1 
Protocol Deviations 
A protocol deviation is defined as any intentional or unintentional change to, or noncompliance 
with, the approved protocol procedures or requirements. Deviations may result from the action or 
inaction of the subject, investigator, or site staff. Examples of deviations include, but are not 
limited to: 
x Failure to adhere to study exclusion and inclusion criteria 
x Failure to comply with dispensing or dosing requirements 
x Use of medications, food, drink, herbal remedies, or supplements that are specifically 
prohibited in the protocol 
x Missed or out-of-window visits 
x Drug dosing not administered within the time frame specified in the protocol 
x Failure to adhere to test requirements, including vital signs, laboratory tests, physical 
examinations, PK blood draws, medical history, etc. – either tests not done, incorrect tests 
done, or not done within the time frame specified in the protocol 

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x Procedural deviations such as incorrect storage of study drug, failure to update the ICF when 
new risks become known, or failure to obtain IRB approvals for the protocol and ICF 
revisions 
At the outset of the study, a process for defining and handling protocol deviations will be 
established. This will include determining which violations will be designated “key,” requiring 
immediate notification to the medical monitor and FAST BioMedical. The investigator is 
responsible for seeing that any known protocol deviations are recorded and handled as agreed. 
12.2 
Protocol Amendments 
Only the sponsor may modify the protocol. Amendments to the protocol will be made only after 
consultation and agreement between the sponsor, the medical monitor, and the investigator. All 
amendments that have an impact on subject risk or the study objectives, or require revision of the 
ICF, must receive approval from the IRB/IEC prior to their implementation. 
12.3 
Monitoring of Study 
The investigator will permit the site monitor to review study data as frequently as is deemed 
necessary to ensure data are being recorded in an adequate manner and protocol adherence is 
satisfactory. 
The investigator will provide access to medical records for the monitor to verify eCRF entries. 
The investigator is expected to cooperate with FAST BioMedical or a designee in ensuring the 
study adheres to GCP requirements. 
The investigator may not recruit subjects into the study until FAST BioMedical or a designee has 
conducted a visit at the site to conduct a detailed review of the protocol and eCRF. With 
agreement of FAST BioMedical, attendance at an investigator meeting may fulfill this 
requirement. 

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13 
ETHICS 
13.1 
Institutional Review Board/Independent Ethics Committee Approval 
13.1.1 
Ethics Review Prior to Study 
The investigator will ensure that the protocol and consent form are reviewed and approved by the 
appropriate IRB/IEC prior to the start of any study procedures. The IRB/IEC will be 
appropriately constituted and will perform its functions in accordance with FDA regulations, 
ICH GCP guidelines, and local requirements as applicable. 
13.1.2 
Ethics Review of other Documents 
The IRB will approve all protocol amendments (except for sponsor-approved logistical or 
administrative changes), written informed consent documents and document updates, subject 
recruitment procedures, written information to be provided to the subjects, available safety 
information, information about payment and compensation available to subjects, the 
investigator’s curriculum vitae and/or other evidence of qualifications, and any other documents 
requested by the IRB/IEC and regulatory authority as applicable. 
13.2 
Written Informed Consent 
The nature and purpose of the study will be fully explained to each subject. The subjects must be 
given ample time and opportunity to inquire about details of the study, to have questions 
answered to their satisfaction, and to decide whether to participate. Written informed consent 
must be obtained from each subject prior to any study procedures being performed. 

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DATA HANDLING AND RECORD KEEPING 
14.1 
Data Reporting and Case Report Forms 
14.1.1 
Case Report Forms 
The investigator will be provided with eCRFs, and will ensure all data from subject visits are 
promptly entered into the eCRFs in accordance with the specific instructions given. The 
investigator must sign the eCRFs to verify the integrity of the data recorded. 
14.1.2 
Laboratory Data 
A list of the normal ranges for all laboratory tests to be undertaken forms part of the 
documentation to be collated prior to study start. If a central laboratory has been selected to 
conduct any or all tests, it is essential all samples be analyzed at that laboratory. The investigator 
must maintain source documents such as laboratory reports and complete history and physical 
examination reports. 
14.1.3 
Retention of Source Documents 
The investigator must maintain source documents such as laboratory reports, x-rays, ECGs, 
consultation reports, and complete history and physical examination reports. 
14.2 
Retention of Essential Documents 
The study essential documents must be maintained as specified in the ICH guidelines for GCP 
and the applicable regulatory requirements. The investigator/institution should take measures to 
prevent accidental or premature destruction of these documents. 
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated marketing 
applications in an ICH region or until at least 2 years have elapsed since the formal 
discontinuation of clinical development of the investigational product. These documents should 
be retained for a longer period, however, if required by the applicable regulatory requirements or 
by an agreement with sponsor. It is the responsibility of FAST BioMedical to inform the 
investigator/institution as to when these documents no longer need to be retained. 

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ADMINISTRATIVE INFORMATION 
15.1 
Financing and Insurance 
Financing and insurance will be addressed in a separate agreement between FAST BioMedical 
and the clinical study sites. 
15.2 
Publication Policy 
FAST BioMedical will retain ownership of all data. All proposed publications based on this 
study will be subject to sponsor’s approval requirements. 

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16 
REFERENCES 
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 
1976;16(1):31-41. 
Cosgriff P.S., Blunkett M., Morrish O. Estimating plasma volume from red cell volume. Nuclear 
Medicine Communications, 1999, 20, 1165-1167. 
Food and Drug Administration. Guidance for Industry: Drug-Induced Liver Injury: Premarketing 
Clinical Evaluation. July 2009. 
Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to 
estimate glomerular filtration rate from serum creatinine: a new prediction equation. 
Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999;130(6):461-70. 
Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, et al. A new 
equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604-12. 
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 
1962;51(2):224-32. 
National Institute of Diabetes and Digestive and Kidney Diseases, Estimating Glomerular 
Filtration Rate. 2015. Available at: http://www.niddk.nih.gov/health-information/health-
communication-programs/nkdep/lab-evaluation/gfr/estimating/Pages/estimating.aspx. Accessed 
30 March 2016. 
OMNIPAQUE™ (Iohexol) injection (prescribing informaton). GE Healthcare Inc; Princeton, NJ. 
2010. 
Report XT12A040.  In vitro evaluation of FD001 and FD003 as an inhibitor of cytochrome P450 
(CYP) enzymes in human liver microsomes.  XenoTech, LLC, May 2013. 
Wang E, Meier DJ, Sandoval RM, Von Hendy-Wilson VE, Pressler BM, Bunch RM. A portable 
fiberoptic ratiometric fluorescence analyzer provides rapid point-of-care determination of 
glomerular filtration rate in large animals. Kidney Int. 2011;81(1):112–7. 

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Appendix A Preparation of FAST Visible Fluorescent Injectate™ 
1. Weigh vial of VFI prior to reconstitution. Record the pre-weight. 
2. Add 4mL of sterile water to the vial of VFI over 4 seconds. 
3. Gently swirl the vial for 3 minutes, avoiding allowing the liquid to reach the rubber stopper. 
4. Place vial on a roller/rocker table to mix for 30 minutes. 
5. Re-weigh vial and record post-weight. 
6. Product is ready for drawing up of dose.