A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Kyntra Bio

CONFIDENTIALITY STATEMENT 
The information contained in this document is confidential and proprietary to FibroGen, Inc. No 
part of this document or any of the information contained herein may be transmitted, disclosed, 
shared, reproduced, published or utilized by any persons without prior written authorization from 
FibroGen, Inc. 
CLINICAL STUDY PROTOCOL 
STUDY TITLE: 
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study 
to Evaluate the Safety and Efficacy of FG-3019 in Patients with 
Idiopathic Pulmonary Fibrosis 
PROTOCOL NUMBER: 
FGCL-3019-067 
SPONSOR: 
FibroGen, Inc. 
409 Illinois Street 
San Francisco, California  94158 USA 
IND NUMBER: 
11212 
EudraCT NUMBER: 
2014-005658-20 
INVESTIGATIONAL 
PRODUCT: 
FG-3019 
INDICATION: 
Idiopathic Pulmonary Fibrosis 
FIBROGEN MEDICAL 
MONITOR: 
Name: 
 
Title: 
 
Work Phone: 
 
Cell Phone: 
  
E-mail Address: 
ORIGINAL PROTOCOL / 
DATE: 
AMENDMENT 1.0: 
AMENDMENT 2.0: 
15 January 2013
09 December 2014 
09 March 2015 
AMENDMENT 3.0: 
28 May 2015 
AMENDMENT 5.1: 
12 December 2016  (Regional: Australia, Bulgaria, India, New 
Zealand and South Africa)  
NCT #: NCT01890265

FG-3019 
 Protocol FGCL-3019-067 Amendment 5.1 
 
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STUDY ACKNOWLEDGEMENT 
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and 
Efficacy of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis  
FGCL-3019-067 
Original:  15 January 2013 
Amendment 1.0: 09 December 2014 
 
Amendment 2.0: 09 March 2015 
Amendment 3.0: 28 May 2015 
Amendment 5.1: 12 December 2016 (Regional: (Regional: Australia, Bulgaria, India, New Zealand 
and South Africa)   
 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices and the current Investigator’s Brochure (IB), and I agree 
that it contains all necessary details for me and my staff to conduct this study as described. I will conduct 
this study as outlined herein and will make a reasonable effort to complete the study within the time 
designated. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by FibroGen, Inc. I will discuss this material with them to ensure that they are fully 
informed about the drug and the study. 
I will conduct the trial in accordance with the guidelines of GCP including the archiving of essential 
documents, the Declaration of Helsinki, the International Conference on Harmonisation (ICH) E6 
Guideline for GCP, the FDA, any applicable local health authority, and Institutional Review Board (IRB) 
requirements. 
 
 
 
Investigator Name (Printed) 
 
Institution 
 
 
 
Signature 
 
Date 
 

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CONFIRMATION OF PROTOCOL APPROVAL 
Original:  15 January 2013 
Amendment 1.0: 09 December 2014 
Amendment 2.0: 09 March 2015 
Amendment 3.0: 28 May 2015 
Amendment 5.1: 12 December 2016 
 
This protocol is approved by FibroGen. 
 
 
 
 
 
  
FibroGen Inc. 
 
Date 
 
 
 

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TABLE OF CONTENTS 
PROTOCOL SYNOPSIS ............................................................................................................. 11 
1 
Introduction ........................................................................................................................... 19 
1.1 
Idiopathic Pulmonary Fibrosis ...................................................................................... 19 
1.2 
Connective Tissue Growth Factor ................................................................................ 22 
1.3 
Connective Tissue Growth Factor in Idiopathic Pulmonary Fibrosis ........................... 23 
1.4 
Investigational Product FG-3019 .................................................................................. 23 
1.5 
Clinical Trial Experience with FG-3019....................................................................... 23 
1.6 
Rationale for FG-3019 in Idiopathic Pulmonary Fibrosis ............................................ 24 
2 
Objectives ............................................................................................................................. 25 
2.1 
Primary Safety Objective .............................................................................................. 25 
2.2 
Primary Efficacy Objective ........................................................................................... 25 
2.3 
Secondary Efficacy Objectives ..................................................................................... 25 
2.4 
Exploratory Efficacy Objectives ................................................................................... 25 
3 
Endpoints and Assessments .................................................................................................. 26 
3.1 
Safety Endpoints and Assessments ............................................................................... 26 
3.2 
Efficacy Endpoints and Assessments............................................................................ 26 
3.2.1 Primary Efficacy Endpoint ....................................................................................... 26 
3.2.2 Secondary Efficacy Endpoints. ................................................................................. 26 
3.2.3 Exploratory Efficacy Endpoints ................................................................................ 26 
4 
Study Design ......................................................................................................................... 27 
4.1 
Study Population ........................................................................................................... 27 
4.2 
Description of the Study ............................................................................................... 27 
4.2.1 Study Periods ............................................................................................................ 27 
4.2.2 Randomized Treatment Phase................................................................................... 28 
4.2.3 Extended Treatment Period (Weeks Identified with –EX Suffix) ............................ 28 
4.2.4 End of Treatment and Follow-up .............................................................................. 29 
4.2.5 Extended Treatment Phase ........................................................................................ 29 
4.2.6 Placebo Control Group ............................................................................................. 30 
4.3 
Treatment Assignment .................................................................................................. 30 
4.4 
Blinding......................................................................................................................... 30 

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4.4.1 Rationale for Blinding............................................................................................... 30 
4.4.2 Maintenance of Blinding........................................................................................... 30 
4.4.3 Unblinding of Treatment Assignment ...................................................................... 30 
4.5 
Study Treatment with FG-3019 .................................................................................... 31 
4.6 
Concomitant Medications, Procedures and Nondrug Therapies ................................... 31 
4.6.1 Concomitant Medications ......................................................................................... 31 
4.6.2 Contraception ............................................................................................................ 31 
4.7 
Safety Plan .................................................................................................................... 32 
4.8 
Independent Data Monitoring Committee .................................................................... 32 
4.8.1 Safety Monitoring ..................................................................................................... 32 
5 
Eligibility Criteria ................................................................................................................. 33 
5.1 
Inclusion Criteria .......................................................................................................... 33 
5.2 
Exclusion Criteria ......................................................................................................... 33 
6 
Study Drug/Treatment Supply .............................................................................................. 36 
6.1 
FibroGen Investigational Product ................................................................................. 36 
6.1.1 Formulation ............................................................................................................... 36 
6.2 
Reference Therapy (Placebo) ........................................................................................ 36 
6.2.1 Formulation ............................................................................................................... 36 
6.3 
Preparation of Dose and Administration....................................................................... 36 
6.4 
Storage .......................................................................................................................... 37 
7 
Study Procedures-All Cohorts Unless Otherwise Specified ................................................. 38 
7.1 
Study Procedures .......................................................................................................... 38 
7.2 
Serial PFT and HRCT ................................................................................................... 38 
7.3 
Blood Volume ............................................................................................................... 38 
7.4 
Missed Visits ................................................................................................................. 38 
7.5 
Unscheduled Visits ....................................................................................................... 39 
7.6 
Assessments .................................................................................................................. 39 
7.6.1 Central Laboratory .................................................................................................... 39 
7.6.2 Local Laboratory(s) .................................................................................................. 39 
7.6.3 Other Reference Laboratories ................................................................................... 39 
7.6.4 Exploratory Biomarkers ............................................................................................ 39 
7.6.5 DNA for Genomic Analysis...................................................................................... 39 
8 
Subject Discontinuation ........................................................................................................ 41 

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8.1 
Replacement of Subjects ............................................................................................... 41 
9 
Study Termination by FibroGen ........................................................................................... 42 
10 Statistics ................................................................................................................................ 43 
10.1 
Sample Size Determination........................................................................................... 43 
10.2 
Analysis Populations ..................................................................................................... 43 
10.2.1 
Safety Population .................................................................................................. 43 
10.2.2 
Full Analysis Set Population ................................................................................. 43 
10.2.3 
HRCT Evaluable Population................................................................................. 43 
10.3 
Statistical Analysis ........................................................................................................ 44 
10.3.1 
General Analysis Methods .................................................................................... 44 
10.3.2 
Subject Enrollment and Disposition ..................................................................... 44 
10.3.3 
Demographics and Baseline Characteristics ......................................................... 44 
10.3.4 
Efficacy Analyses ................................................................................................. 44 
10.3.5 
Safety Analyses ..................................................................................................... 45 
10.3.6 
Interim Analyses ................................................................................................... 45 
10.4 
Statistical Analysis Plan ................................................................................................ 46 
11 Assessment of Safety ............................................................................................................ 47 
11.1 
Background ................................................................................................................... 47 
11.2 
Definitions..................................................................................................................... 47 
11.2.1 
Definition of an Adverse Event (AE) ................................................................... 47 
11.2.2 
Definition of a Serious Adverse Event (SAE) ...................................................... 47 
11.2.3 
Definition of a Suspected Adverse Reaction ........................................................ 48 
11.2.4 
Definition of an Adverse Reaction ....................................................................... 48 
11.2.5 
Special Situations .................................................................................................. 48 
11.3 
Procedures for Eliciting, Recording, and Reporting Adverse Events ........................... 48 
11.3.1 
Adverse Event Reporting Period .......................................................................... 48 
11.3.2 
Adverse Event Eliciting/Reporting ....................................................................... 49 
11.3.3 
Assessing Adverse Event Severity........................................................................ 49 
11.3.4 
Assessing the Adverse Event’s Relationship to Study Drug ................................ 50 
11.3.5 
Reporting Serious Adverse Events on the SAE Report Form .............................. 51 
11.3.6 
Pregnancies: Reporting and Follow-up of Subjects .............................................. 52 
11.3.7 
Abnormal Laboratory Findings............................................................................. 52 
12 Study Monitoring .................................................................................................................. 54 

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12.1 
Data Quality Assurance ................................................................................................ 54 
12.2 
Compliance with Laws and Regulations....................................................................... 54 
12.3 
Audit and Inspection ..................................................................................................... 54 
12.4 
Data Collection and Handling ....................................................................................... 55 
12.4.1 
Source Documents ................................................................................................ 55 
12.4.2 
Data Collection, Handling, and Verification ........................................................ 55 
13 Human Subjects .................................................................................................................... 56 
13.1 
Ethical Considerations .................................................................................................. 56 
13.2 
Communication with the Institutional Review Board .................................................. 56 
13.3 
Informed Consent Form ................................................................................................ 56 
13.4 
Subject Confidentiality ................................................................................................. 56 
14 Investigator Requirements .................................................................................................... 57 
14.1 
Study Medication Accountability ................................................................................. 57 
14.2 
Disclosure of Data......................................................................................................... 57 
14.3 
Study Files and Retention of Records ........................................................................... 57 
15 Publication Policy ................................................................................................................. 58 
16 References ............................................................................................................................. 59 
17 Appendices ............................................................................................................................ 66 
 
LIST OF FIGURES 
Figure 1. 
Study Schema............................................................................................................ 28 
LIST OF APPENDICES 
Appendix 1. 
Schedule of Assessments ─ Randomized Treatment Phase ................................. 67 
Appendix 2. 
Schedule of Assessments ─ Extended Treatment Phase ...................................... 69 
Appendix 3. 
Schedule of Assessments ─ End of Treatment and Follow-up ............................. 71 
Appendix 4. 
HRCT Criteria and Histopathological Criteria for UIP Pattern* .......................... 72 
Appendix 5. 
Radiation Risk Assesment .................................................................................... 73 
 
 
 

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LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
AEs 
adverse events 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
ATS 
American Thoracic Society 
BMPs 
bone morphogenetic proteins 
BP 
blood pressure 
CCN 
cysteine-rich 61/CTGF/nephroblastoma overexpression 
CFR 
Code of Federal Regulations 
CPAP 
continuous positive airway pressure 
CRF 
case report form 
CTGF 
connective tissue growth factor 
DLCO 
diffusing capacity of the lung for carbon monoxide 
DNA 
deoxyribonucleic acid 
DMC 
Data Monitoring Committee 
ECG 
electrocardiogram 
ECM 
extracellular matrix 
EMT 
epithelial-mesenchymal transition 
EOS 
end of study 
FDA 
US Food and Drug Administration 
FEV1 
forced expiratory volume in 1 second 
FG-3019 
FibroGen-3019 (recombinant human monoclonal antibody) 
FVC 
forced vital capacity  
GCP 
Good Clinical Practice 
HAHA 
human anti-human antibody 
HRQoL 
health-related quality of life 
Hb 
hemoglobin 
HIPAA 
Health Insurance Portability and Accountability Act  
HRCT 
high resolution computed tomography 
HSPG 
heparin sulfate proteoglycans 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IND 
Investigational New Drug  

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INR 
international normalized ratio 
IL-1β 
interleukin-1 beta 
IL-4 
interleukin-4 
IL-10 
interleukin-10 
IL-13 
interleukin-13 
IL-17 
interleukin-17 
IPF 
idiopathic pulmonary fibrosis 
IRB 
Institutional Review Board 
IV 
intravenous, intravenously 
kDa 
kilodalton 
LRP 
lipoprotein receptor-related protein 
MedDRA 
Medical Dictionary for Regulatory Activities 
mRNA 
messenger ribonucleic acid 
NAC 
N-acetylcysteine 
NCI 
National Cancer Institute 
NCI CTCAE, v4.0 
NCI Common Terminology Criteria for Adverse Events, Version 4.0 
NSAIDs 
non-steroidal anti-inflammatory drugs 
NYHA 
New York Heart Association 
OTC 
over-the-counter 
PDGF 
platelet-derived growth factor 
PFTs 
pulmonary function tests 
PP 
per protocol 
SAEs 
serious adverse event(s) 
SaO2 
oxyhemoglobin saturation 
SAP 
statistical analysis plan 
SGRQ 
Saint George’s Respiratory Questionnaire 
SPARC 
secreted protein acidic and rich in cysteine 
TE-AE 
treatment-emergent adverse event 
TE-SAE 
treatment-emergent serious adverse event 
TGF-β 
transforming growth factor-β 
TLC 
total lung capacity 
TNF-α 
tumor necrosis factor-α 
UIP 
usual interstitial pneumonia 
ULN 
upper limit of normal 
VEGF 
vascular endothelial growth factor 
WHODrug 
World Health Organization Drug Dictionary 

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AMENDMENT 5.1: KEY CHANGES FROM AMENDMENT 3.0 
The protocol has been edited for clarity, consistency, and quality of content (typos, grammatical 
errors, etc.). A redline version documenting all changes from the previous version of this 
document is available upon request.  
Key Change 
Rationale 
Sections Affected 
The Follow Up / End of Study 
Visit is now scheduled at 4 
weeks after the last dose of 
study drug (instead of 10 
weeks). 
 
The change in the schedule of 
the  Follow Up/End of Study 
Visit is supported by 
pamrevlumab’s drug PK 
characteristics and available 
safety data. 
 
Protocol Synopsis, Sections 4 
and 11, Appendix 2 and 
Appendix 3. 
 
 

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PROTOCOL SYNOPSIS 
Study Title: 
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to 
Evaluate the Safety and Efficacy of FG-3019 in Patients with Idiopathic 
Pulmonary Fibrosis 
Protocol Number: 
FGCL-3019-067, Amendment 5.1 
Investigational Product: 
FG-3019 
Target Population: 
Male or female subjects, 40 to 80, years old who have IPF 
diagnosed in accordance with criteria published in the 2011 
international consensus guidelines. Subjects who have failed or are 
intolerant of products approved for treating IPF are eligible.  
 
IND Number: 
011212 
Study Phase: 
Phase 2 
Study Centers Planned: 
Approximately 60 centers in the United States and other countries 
Number of Subjects 
Planned: 
Approximately 136 
Objective: 
The overall objective of this study is to evaluate the safety, 
tolerability, and efficacy of FG-3019 in subjects with IPF 
Primary Safety 
Objective: 
• To determine the safety and tolerability of FG-3019 
administered at a dose of 30 mg/kg by intravenous (IV) infusion 
every 3 weeks  
Primary Efficacy 
Objective: 
• To determine the effect of FG-3019 on forced vital capacity 
(FVC) (percent of predicted value) in the target population  
Secondary Efficacy 
Objectives: 
• To evaluate the effect of FG-3019 on the extent of pulmonary 
fibrosis as measured by high resolution computed tomography 
(HRCT) scans of the chest 
• To evaluate the relationship between changes in quantified 
scores of pulmonary fibrosis and clinical outcomes 
• To evaluate the effect of FG-3019 on progression of IPF and the 
frequency of respiratory-related hospitalizations and respiratory-
related mortality  
• To evaluate the effect of FG-3019 on health-related quality of 
life (HRQoL) 

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Exploratory Efficacy 
Objectives: 
• To evaluate the effect of FG-3019 on FVC (liters) 
• To evaluate the effect of FG-3019 on a panel of serum and 
plasma biomarkers 
• To evaluate the relationship between known chromosomal loci 
associated with IPF and the response to FG-3019 
Study Design: 
This is a Phase 2, randomized, double-blind, placebo-controlled 
multicenter study. Subjects who have failed or are intolerant of 
products approved for treating IPF are eligible. Other subjects must 
be fully informed of the potential benefits of approved products and 
make an informed decision that they prefer to participate in a 
clinical trial in which they may be randomized to placebo. 
Randomized Treatment Period 
Subjects who sign informed consent will undergo screening visits to 
determine their eligibility. Eligible subjects who provide written 
informed consent will be stratified based on prior therapy with 
nintedanib and/or pirfenidone (yes/no) and randomized (1:1) to one 
of two treatment arms: 
 
Arm A: FG-3019, 30 mg/kg  
 
Arm B: Matching placebo 
Treatment should begin within 42 days of the first screening visit. 
Study Drug (FG-3019 [30 mg/kg] or placebo) will be administered 
by IV infusion every 3 weeks for a total of 16 infusions over 
48 weeks. At the time of roll over into the Extended Treatment 
Period, the study subject treatment assignment will be unblinded 
only to designated personnel not associated with the study at 
FibroGen Inc. 
Extended Treatment Period 
Subjects Enrolled under the Original Protocol and Assigned to Arm 
A: FG-3019 
All subjects in Arm A whose FVC percent predicted value shows 
less than 3% absolute decrease from baseline in the Randomized 
Treatment Period will be offered participation in an Extended 
Treatment Period. These subjects may continue treatment until FVC 
percent predicted decreases 3% or more on two consecutive 
scheduled evaluations compared to the original pre-treatment 
baseline. 
 
Subjects Enrolled Under Amendment 1 or Subsequent Amendments 
and Assigned to Arm A: FG-3019 
All subjects in Arm A whose FVC percent predicted value is greater 
than the original pre-treatment baseline in the Randomized 

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Treatment Period will be offered participation in an Extended 
Treatment Period and may continue treatment until FVC percent 
predicted is equal to or less than the pre-treatment baseline on two 
consecutive scheduled evaluations. 
 
Subjects Enrolled Under the Original Protocol,  Amendment 1 or 
Subsequent Amendments Assigned to Arm B: Placebo 
All subjects assigned to Placebo (Arm B) will be offered 
participation in the Extended Treatment Phase for 45 weeks. 
Placebo subjects in the extension study are treated identically to 
subjects randomized to FG-3019 in Amendment 1, except for the 
fact that the baseline for these patients is the time at which they are 
enrolled into the extension phase (Baseline for Placebo subjects is 
Week 48 value). Change in FVC percent predicted during the 
extended treatment phase will be compared to this new baseline. 
Those subjects whose FVC percent predicted value at Week 48 of 
the Extension Period  is greater than the new baseline may continue 
treatment with FG-3019 until FVC percent predicted is equal to or 
less than the  baseline on two consecutive scheduled evaluations. 
See Section 4.2.3 for details regarding the Extended Treatment 
Period. 
Study Periods 
Screening Period (up to 6 weeks) 
Randomized Treatment Period (48 weeks) 
Extended Treatment Period (sub-set of subjects [see definition 
above]; duration based on changes in FVC (Section 4.2.3) 
Follow-Up Period (all subjects will undergo a final safety 
assessment at 4 weeks after last dose of study drug.) 
Study Population 
Male or female subjects 40 to 80 years old who have IPF diagnosed 
in accordance with criteria published in the 2011 international 
consensus guidelines.  
Diagnosis and Main 
Eligibility Criteria 
Inclusion Criteria:  
1. Age 40 to 80 years, inclusive. 
2. Diagnosis of IPF as defined by current international guidelines 
(Raghu, 2011). Each subject must have one of the following: (1) 
Usual Interstitial Pneumonia (UIP) Pattern on an available 
HRCT scan; or (2) Possible UIP Pattern on an available HRCT 
scan and surgical lung biopsy within 4 years of Screening 
showing UIP Pattern (HRCT criteria for UIP Pattern and 
Possible UIP Pattern and histopathological criteria for UIP 
Pattern are described in Appendix 4). 
3. History of IPF of ≤5 years duration with onset defined as the 
date of the first diagnosis of IPF by HRCT or surgical lung 

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biopsy. 
4. Interstitial pulmonary fibrosis defined by HRCT scan at 
Screening, with evidence of ≥10% to <50% parenchymal 
fibrosis (reticulation) and <25% honeycombing, within the 
whole lung, as determined by the HRCT central reader.  
5. FVC percent of predicted value ≥55% at Screening. 
6. Female subjects of childbearing potential and male subjects with 
female partners of childbearing potential are required to use 
double barrier contraception methods during the conduct of the 
study and for 3 months after the last dose of study drug.  
Exclusion Criteria:   
1. Female subjects who are pregnant or nursing. 
2. Infiltrative lung disease other than IPF, including any of the 
other types of idiopathic interstitial pneumonias (Travis, 2013); 
lung diseases related to exposure to fibrogenic agents or other 
environmental toxins or drugs; other types of occupational lung 
diseases; granulomatous lung diseases; pulmonary vascular 
diseases; systemic diseases, including vasculitis and connective 
tissue diseases.  
3. HRCT scan findings at Screening are inconsistent with UIP 
Pattern, as determined by the HRCT central reader (a definition 
of “Inconsistent with UIP Pattern” is provided in Appendix 4). 
4. Pathology diagnosis on surgical lung biopsy is anything other 
than UIP Pattern, as determined by the local pathologist 
(Appendix 4). 
5. The Investigator judges that there has been sustained 
improvement in the severity of IPF during the 12 months prior to 
Screening, based on changes in FVC, diffusing capacity of the 
lung for carbon monoxide (DLCO), and/or HRCT scans of the 
chest. 
6. History of other types of respiratory diseases including diseases 
or disorders of the airways, lung parenchyma, pleural space, 
mediastinum, diaphragm, or chest wall that, in the opinion of the 
Investigator, would impact the endpoints in the protocol or 
otherwise preclude the subject’s participation in the study. 
7. History of any other respiratory, cardiovascular, renal, hepatic, 
metabolic, neurologic, hematologic, or other medical conditions 
that, in the opinion of the Investigator, would preclude the 
subject’s participation in the study. 
8. Clinically important abnormal laboratory tests (including serum 
creatinine ≥1.5 x upper limit of normal [ULN], hemoglobin (Hb) 
<10 g/dL, white blood cells <3,000/mm3, platelets less than 

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100,000/mm3, serum total bilirubin >1.5 x ULN, serum alanine 
aminotransferase (ALT) or aspartate aminotransferase (AST) 
≥2 x ULN, or serum alkaline phosphatase ≥2 x ULN. 
9. Upper or lower respiratory tract infection of any type within 
4 weeks of Screening. 
10. Acute exacerbation of IPF within 3 months of Screening. 
11. Evidence of obstructive lung disease by any of the following 
criteria: forced expiratory volume in 1 second/forced vital 
capacity (FEV1/FVC) ratio <0.70 or extent of emphysema on 
HRCT greater than the extent of fibrosis on HRCT. 
12. DLCO <30% of predicted value. 
13. High likelihood of lung transplantation (in the opinion of the 
Investigator) within 6 months after Day 1. 
14. Poorly controlled chronic heart failure; clinical diagnosis of cor 
pulmonale requiring specific treatment; or severe pulmonary 
hypertension requiring specific treatment that, in the opinion of 
the Investigator, would preclude the subject’s participation in the 
study.  
15. Use of medications to treat IPF within 5 half-lives of Day 1 
dosing. If monoclonal antibodies were used, the last dose of the 
antibody must be at least 4 weeks before Day 1 dosing. 
16. Use of any investigational drugs, including any investigational 
drugs for IPF, within 4 weeks prior to Day 1 dosing. 
17. History of cancer diagnosis of any type in the 3 years preceding 
Screening, excluding non-melanomatous skin cancer, localized 
bladder cancer, or in situ cancers.  
18. Clinically significant trauma or surgical procedures within 
4 weeks prior to dosing. 
19. Planned elective surgery during the study including 4 weeks 
following the final dose of Study Drug. 
20. History of allergic or anaphylactic reaction to human, 
humanized, chimeric or murine monoclonal antibodies. 
21. The Investigator judges that the subject will be unable to fully 
participate in the study and complete it for any reason, including 
inability to comply with study procedures and treatment, 
addiction, or any other relevant medical or psychiatric 
conditions. 
22. Body weight >130 kg. 
23. Previous treatment with FG-3019. 
24. Inadequate IV access.  

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Concomitant 
Medications/Therapies 
Oral prednisone or equivalent oral corticosteroid (up to 10 mg daily) 
and N-acetylcysteine (NAC) (up to 1800 mg daily) are allowed. 
Medications that, in the opinion of the Investigator, are required for 
the treatment of acute exacerbations of IPF during the Treatment 
Period are acceptable. 
Female subjects of childbearing potential and male subjects with 
female partners of childbearing potential are required to use double 
barrier contraception methods during the conduct of the study and 
for 3 months after the last dose of study drug.  
Investigational Product, 
Dose, and Mode of 
Administration 
FG-3019 is a fully human IgG1 kappa monoclonal antibody that 
binds to connective tissue growth factor (CTGF). It will be 
administered at a dose of 30 mg/kg by IV infusion in a total volume 
of 250 mL (up to 400 mL if necessary) normal saline every 3 weeks.  
Reference Therapy 
(and/or Placebo), Dose, 
and Mode of 
Administration 
Placebo (identical to the FG-3019 vehicle) will be handled and 
administered in a manner that is identical to FG-3019. 
Safety Endpoints and 
Assessments 
• Adverse events and serious adverse events (SAEs) 
• Laboratory test abnormalities  
• 12-lead ECGs 
• Physical examinations 
• Human anti-human antibodies (HAHA) 
Efficacy Endpoints and 
Assessments 
Primary efficacy endpoint 
• Change from baseline in FVC (percent of predicted value) at 
Week 48. 
Secondary efficacy endpoints  
• Change in pulmonary fibrosis score by quantitative HRCT at 
Week 24, Week 48, and later time points. 
• Change from baseline in HRQoL at Week 24, Week 48, and 
later time points. 
• Progression of IPF, defined as time from Day 1 to any one of the 
following: 
o Death from any cause 
o Absolute decline FVC percent of predicted value of ≥10% 
not due to intercurrent illness, confirmed by repeat 
spirometry 

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o Clinical diagnosis of IPF progression. 
• Proportion of subjects with at least one respiratory-related 
hospitalization. 
• Proportion of subjects with respiratory-related death, censored at 
Week 52. 
• Categorical assessment of absolute change from baseline in FVC 
percent of predicted value at Week 48. 
Exploratory efficacy endpoints  
• Change from baseline to Week 24 and from baseline to Week 48 
in FVC (liters). 
• Change from Day 1 to Week 48 in a panel of serum and plasma 
biomarkers that will be determined by FibroGen. 
• Relationship between known chromosomal loci associated with 
IPF and the response to FG-3019. 
Statistical Methods: 
This study is planned to enroll approximately 136 subjects, who will 
include a target of 110 subjects who are seeking first-line therapy 
and approximately 26 subjects who failed pirfenidone and/or 
nintedanib treatment. First line therapy is defined as no prior therapy 
with pirfenidone and/or nintedanib or <10% relative decrease in 
FVC % predicted while receiving either pirfenidone or nintedanib. 
Pirfenidone and/or nintedanib failure is defined as having ≥10% 
relative decrease in FVC % predicted during prior pirfenidone 
and/or nintedanib treatment. The effect of first-line treatment is the 
primary interest of the study and is the basis for sample size 
estimates. Assuming a 10% dropout rate and a common standard 
deviation of 7.3, a sample size of 55 subjects per arm in the primary 
analysis population provides approximately 80% power to detect a 
treatment difference of 4.2 in change from baseline to Week 48 in 
percent predicted FVC, using a two-sample t-test at the two-sided 
significance level of 0.05. If the treatment effect in the pirfenidone 
and/or nintedanib treatment failure group is similar to that in the 
general population, the two subgroups will be combined to achieve 
higher power. 
The primary efficacy analysis is to compare the treatment arms in 
change from baseline to Week 48 in FVC % predicted. A rank 
ANCOVA model will be used. A repeated measures model utilizing 
all observed data will be used for sensitivity analyses. Logistic 
regression and Fisher’s exact test will be used to compare 
categorical endpoints. The Cox regression model will be used in 
time-to-event endpoints. All efficacy and safety data will be 
summarized descriptively by treatment arm. 

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Treatment effect will be evaluated in various subgroups of interest. 
Unblinded analyses will be performed after all subjects have either 
completed the Week 48 assessments or discontinued the study. 
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) and the 
applicable regulatory requirement(s), including the archiving of essential documents. 

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1 
INTRODUCTION 
1.1 
Idiopathic Pulmonary Fibrosis 
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive fatal lung disease of unknown 
etiology characterized by fibrotic interstitial infiltrates that are consistent with the 
histopathologic pattern of usual interstitial pneumonia (Gross, 2001, Raghu, 2011). IPF is the 
most common of seven recognized types of idiopathic interstitial pneumonia (Kim, 2006, 
Travis, 2013).  
The pathogenesis of IPF has not been clearly defined. The long-held view that fibrosis in IPF is 
triggered by chronic inflammation (alveolitis) has given way to the current belief that IPF is a 
disorder caused by repetitive epithelial injury (Selman, 2001, Selman, 2006, Wilson, 2009). 
According to this hypothesis, alveolar cell injury and activation initiate a dysregulated, 
exaggerated fibrotic healing process characterized by myofibroblast proliferation and progressive 
deposition of extracellular matrix (ECM) in genetically susceptible individuals (Agostini, 2006, 
Gross, 2001, Selman, 2004, Selman, 2006, Willis, 2006). Extracellular matrix deposition and 
other pathologic processes in IPF, including epithelial basement membrane disruption, 
angiogenesis, smooth muscle cell proliferation, infiltration of mononuclear cells, accumulation 
of loose connective tissue, and cyst formation, eventually remodel the normal lung architecture 
and impair the lung’s ability to perform gas exchange.  
Exogenous and endogenous insults to the alveolar epithelium have been proposed as possible 
stimuli of the fibrotic process in IPF, but conclusive associations have not been established. The 
most commonly cited exogenous triggers of alveolar injury are exposure to cigarette smoke 
(Baumgartner, 1997, Flaherty, 2004) and environmental and occupational dusts (Hubbard, 2001, 
Taskar, 2006), viral infection (Kelly, 2002, Tang, 2003), and gastroesophageal 
reflux(Raghu, 2006a). Alveolar epithelial cell apoptosis and failure of alveolar re-
epithelialization (Barbas-Filho, 2001, Li, 2004, Selman, 2001, Selman, 2006), resistance of 
myofibroblasts to apoptosis (Thannickal, 2006), oxidant stress (Beeh, 2002, Cantin, 1987, 
Daniil, 2008, Hunninghake, 2005, Waghray, 2005), activation of the coagulation cascade 
(Chambers, 2008, Selman, 2001), and circulating bone marrow-derived fibroblast precursors 
(fibrocytes) (Andersson-Sjoland, 2008, Hashimoto, 2004) have also been implicated in the 
pathogenesis of IPF. Genetic factors may play a role, as gene mutations account for some cases 
of familial IPF (Lawson, 2006), including mutations in the gene encoding surfactant protein C 
and telomerase genes that are responsible for telomere length shortening (Armanios, 2007, 
Loyd, 2008, Tsakiri, 2007).  
Transforming growth factor-beta (TGF-β) is a key cytokine thought to drive the fibrotic process 
in IPF (Agostini, 2006, Bergeron, 2003). Other cytokines, including connective tissue growth 
factor (CTGF), platelet-derived growth factor (PDGF), tumor necrosis factor-alpha (TNF-α), 
endothelin-1, interleukin (IL)-1β, IL-4, IL-10, IL-13, IL-17, osteopontin, matrix 
metalloproteases, and multiple chemokines have been implicated in this complex process of 
cellular interactions among activated epithelial cells, myofibroblasts, fibroblasts, macrophages, 
endothelial cells, and lymphocytes (Agostini, 2006, Ask, 2006, Pardo, 2006, Selman, 2004, 
Selman, 2006, Strieter, 2007, Wilson, 2009). The roles of epithelial-mesenchymal transition 
(EMT) and circulating fibrocytes and other extrapulmonary fibroblast progenitor cells in 
expanding the myofibroblast population within the lung are gaining increased attention 

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(Lama, 2006, Strieter, 2009, Willis, 2006). Connective tissue growth factor has been shown to be 
a central mediator of tissue remodeling and fibrosis and has been reported to be a downstream 
mediator that is essential for the fibrotic activity of TGF- β (Blom, 2002, Grotendorst, 1997). 
The epidemiology of IPF is not clearly defined. Retrospective data from a large health care 
claims database suggest that the prevalence of IPF ranges from 14.0 to 42.7 per 100,000 and the 
annual incidence ranges from 6.8 to 16.3 per 100,000, depending on the strictness of the 
diagnostic criteria employed (Raghu, 2006b). Among persons aged 18 and older in the United 
States, as many as 89,000 people have been diagnosed with IPF, and as many as 34,000 are 
newly diagnosed each year (Raghu, 2006b). A recent report of a population-based study of adults 
with IPF in Olmstead County, Minnesota, from 1997 to 2005, revealed a prevalence of IPF of 
27.9 to 63 cases per 100,000, and an incidence of 8.8 to 17.4 cases per 100,000, again depending 
on the diagnostic criteria (Fernandez Perez, 2010). The prevalence of IPF increases with age, and 
most IPF patients are age 60 or older at the time of diagnosis. The disease is more common in 
men than in women (Fernandez Perez, 2010). Most patients are current or former smokers. 
A familial form of IPF may account for as many as 20% of cases of IPF (Loyd, 2008).  
Patients with IPF suffer from progressive dyspnea and cough, and most have been symptomatic 
for several years by the time of their initial presentation. Delayed diagnosis is therefore common. 
Physical examination often reveals bibasilar inspiratory crackles, but it may be normal. Digital 
clubbing is observed in about one quarter of IPF patients (King, Jr., 2001). The chest radiograph 
reveals non-specific bilateral, reticular infiltrates in the periphery of the lower lung zones, often 
with findings suggestive of pulmonary hypertension. Pulmonary function tests demonstrate 
reduced lung volumes, proportionate reduction in the pulmonary diffusing capacity, and a normal 
to increased forced expiratory volume in 1 second (FEV1/FVC ratio) (Martinez, 2006). Arterial 
hypoxemia, oxyhemoglobin desaturation, and an increased alveolar-arterial oxygen gradient that 
worsens with exercise are typically observed in patients with IPF (Idiopathic pulmonary fibrosis: 
diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), 
and the European Respiratory Society (ERS), 2000, King, Jr., 2001). High resolution computed 
tomography (HRCT) scans display subpleural reticular abnormalities and honeycombing, 
especially in the lung bases (Kim, 2006). Traction bronchiectasis is a common finding. The 
presence of extensive ground glass opacities, peribronchial and perivascular predominance of 
infiltrates, discrete lung cysts, small nodules, air trapping, mosaic attenuation, and consolidation 
suggest alternative diagnoses (Misumi, 2006). The sensitivity and specificity of HRCT for the 
diagnosis of IPF in the hands of expert radiologists approach 90% and 80%, respectively 
(Kim, 2006, Raghu, 1999). 
Acute exacerbations of IPF, characterized by worsening dyspnea over one month or less, new 
diffuse lung infiltrates and ground-glass opacities on HRCT, and worsening hypoxemia in the 
absence of pulmonary infection or other identifiable causes, punctuate the natural course of the 
disease, especially in its pre-terminal phase (Collard, 2007, Hyzy, 2007, Kim, 2006, Walter, 
2006). These exacerbations are often fatal events (Hyzy, 2007, Kim, 2006, Martinez, 2005). The 
etiology of acute exacerbations of IPF is unknown, and its pathogenesis is not well understood 
(Collard, 2007). IPF-related exacerbations occurred at a rate of 0.13 per person-year in the 
Olmstead County population-based study reported above (Fernandez Perez, 2010). A less 
common, rapidly progressive form of IPF, which is common in actively smoking males, has been 
described (Selman, 2007).  

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The diagnosis of IPF is suspected when the clinical and radiographic features described above 
occur in a patient with no known risk factors for interstitial disease and after other types of 
idiopathic interstitial pneumonias have been excluded. Transbronchial lung biopsy and 
bronchoalveolar lavage are occasionally performed to rule other causes of lung infiltrates. The 
diagnosis of IPF is confirmed when HRCT demonstrates definite features of “usual interstitial 
pneumonia” (UIP) (subpleural, reticular infiltrates with basal predominance, honeycombing, and 
absence of the features suggesting a different diagnosis) in the appropriate clinical setting 
(Raghu, 2011). Surgical lung biopsy, long considered the gold standard for diagnosis of IPF, is 
now performed in a minority of cases because of the morbidity associated with the procedure and 
increasing acceptance of diagnosis by HRCT (Raghu, 1999). Nevertheless, combined clinical, 
radiologic, and pathologic correlation is recommended as the optimal approach to diagnosis.  
The histopathologic pattern of UIP is a heterogeneous, patchy involvement of lung parenchyma 
with areas of relatively normal lung tissue adjacent to areas that display architectural distortion 
(“spatial heterogeneity”), infiltrates of fibroblasts and myofibroblasts, collagen deposition, 
honeycombing, Type II pneumocyte hyperplasia, smooth muscle hyperplasia, and buds of young 
proliferating fibroblasts adjacent to alveoli called “fibroblastic foci” (Raghu, 2011, 
Selman, 2006, Visscher, 2006). These histopathologic features are more commonly found in 
subpleural regions in the lower lung zones. Interstitial infiltrates of lymphocytes and plasma cells 
are usually not prominent (Visscher, 2006). 
Pirfenidone and nintedanib are approved drugs for the treatment of IPF. In addition to these 
drugs, IPF patients are usually managed with supportive measures such as symptomatic 
treatment of cough and dyspnea, supplemental oxygen for hypoxemia, smoking cessation, 
pulmonary rehabilitation, and prophylaxis and control of respiratory tract infections (Idiopathic 
pulmonary fibrosis: diagnosis and treatment. International consensus statement. American 
Thoracic Society (ATS), and the European Respiratory Society (ERS), 2000, Walter, 2006, 
Wuyts, 2009). Corticosteroids and the immunosuppressive drugs cyclophosphamide and 
azathioprine were commonly prescribed for IPF in the past, but there is no evidence that these 
drugs improve patient outcomes or alter the natural course of the disease (Collard, 2004, Walter, 
2006). Furthermore, IPF subjects taking a combination of prednisone, azathioprine, and 
N-acetylcysteine (NAC) in one arm of a three-arm multicenter Phase 3 clinical trial experienced 
increased risks of hospitalization and death compared with those taking NAC only or placebo 
only (Raghu, 2012). A recent multicenter Phase 3 randomized trial of warfarin in patients with 
progressive IPF was stopped because of increased mortality in subjects taking warfarin compared 
with those taking placebo (Noth, 2012). Lung transplantation is the only treatment that improves 
survival (Noth, 2007, Walter, 2006), but most IPF patients are not eligible for transplantation 
because of their age or comorbid conditions. 
The natural course of IPF is variable. Patients with IPF typically experience slowly progressive 
worsening of lung function over time, but some experience rapid declines and frequent 
hospitalizations in the late stage of the disease (Martinez, 2005). In two Phase 3 clinical trials 
examining the safety and efficacy of pirfenidone in patients with IPF, the mean decline in 
percent predicted FVC from baseline to 72 weeks was 12.4% in one group receiving placebo and 
9.6% in the other placebo group (Karimi-Shah, B., 2010). As the interstitial fibrosis and 
architectural distortion advance in IPF, the lung becomes more noncompliant, and the work of 
breathing and dyspnea increase. Progressive pulmonary hypertension and cor pulmonale often 
characterize the late course of the disease. The median survival is about 7 years after the onset of 

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symptoms and 3 years after the initial clinic visit (King, Jr., 2001). In patients over the age of 70, 
the median survival is about 15 months after the initial clinic visit (King, Jr., 2001). 
The 5-year survival rate of patients with IPF is approximately 20% to 40% (Kim, 2006), which is 
worse than that of all major cancers except cancer of the lung, pancreas, and esophagus 
(Siegel, 2012). Mortality from IPF was reported to have increased 28% in men and 41% in 
women between 1992 and 2003 (Olson, 2007). The majority of IPF patients die from 
complications of the disease, such as respiratory failure, pulmonary hypertension, and 
pneumonia, or from coronary artery disease (Daniels, 2008, Gross, 2001, Martinez, 2005, 
Olson, 2007). The high mortality rate of IPF and the modest efficacy of approved drugs to treat 
IPF underscore the need to explore new pharmacologic approaches to manage this devastating 
disease. 
1.2 
Connective Tissue Growth Factor  
Connective tissue growth factor is a 38 kDa secreted matricellular glycoprotein of the 
cysteine-rich 61/CTGF/nephroblastoma overexpression (CCN) family (Perbal, 2004, 
Rachfal, 2005). It is produced by many cells, including fibroblasts, myofibroblasts, endothelial 
cells, mesangial cells, and stellate cells.  
The name “connective tissue growth factor” implies a mechanism of action akin to that of 
classical growth factors, which signal through specific cell-surface receptors. However, 
experimental evidence does not support this concept. Instead, CTGF and the other members of 
the CCN family have activities associated with matricellular proteins that function in a more 
subtle modulatory fashion. Matricellular proteins, with prototypical representatives including 
secreted protein acidic and rich in cysteine (SPARC), osteopontin, and thrombospondins, are a 
subclass of ECM proteins that modulate cellular functions and signaling pathways through 
multiple mechanisms depending on cell type and the cellular context (Bornstein, 2002). These 
proteins are generally expressed at high levels during development and in response to injury; 
they typically bind to multiple cell-surface receptors, ECM components, growth factors, and 
cytokines. Connective tissue growth factor fits squarely within this definition (Chen, 2009). The 
cellular functions that can be modulated by CTGF include secretion and/or organization of ECM, 
cell proliferation, survival, adhesion, migration and EMT. Modulation of cellular signaling 
appears to occur through interactions of CTGF with 1) cell surface components such as integrins 
or the low density lipoprotein receptor-related protein (LRP)-1 (a multifunctional endocytic and 
signaling receptor), 2) cytokines and cytokine inhibitors, and 3) matrix components such as 
heparin sulfate proteoglycans (HSPGs) and fibronectin. Interactions with HSPGs may displace 
other HSPG-binding proteins such as VEGF and bone morphogenetic proteins (BMPs). It is 
believed that binding of cytokines to CTGF may either sequester them in an inactive 
conformation, or help to present cytokine binding partners to their receptors. 
Connective tissue growth factor is a central mediator of tissue remodeling and fibrosis 
(Lipson, 2012). Connective tissue growth factor is essential for the fibrotic activity of TGF-β 
(Mori, 1999, Wang, 2011) but it may also act independently of TGF-β. While much has been 
made of the role of TGF-β in fibrosis, studies of the role of fibronectin in pulmonary fibrosis 
showed that the activity of TGF-β is dependent on cellular fibronectin to induce myofibroblast 
differentiation and that cellular fibronectin may have a fundamental role in activation of latent 
TGF-β (Muro, 2008). Shi-wen and colleagues showed that critical activities of TGF-β in the 
fibrotic process are dependent on CTGF expression, including EMT and ECM deposition, 

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supporting the idea that CTGF over-expression is critical for activities attributed to TGF-β 
(Shi-wen, 2006). 
Connective tissue growth factor has been shown to be an important mediator of pulmonary 
fibrosis in a mouse model of bleomycin-induced pulmonary fibrosis (Bonniaud, 2004). Lasky 
and coworkers observed upregulation of CTGF messenger ribonucleic acid (mRNA) gene 
expression in a mouse model of bleomycin-induced pulmonary fibrosis, suggesting a possible 
role of CTGF in the pathogenesis of lung fibrosis (Lasky, 1998). 
1.3 
Connective Tissue Growth Factor in Idiopathic Pulmonary Fibrosis 
Transcripts of genes for TGF-β1 and CTGF were reported to be approximately 7-fold and 4-fold 
higher, respectively, in transbronchial lung biopsy specimens of patients with IPF compared with 
normal (Ziesche, 1999). TGF-β is expressed at fibrogenic foci in IPF (Broekelmann, 1991). 
Increased CTGF gene expression has been described in transbronchial biopsy specimens and in 
bronchoalveolar lavage fluid in patients with IPF (Allen, 1999, Pan, 2001). Allen and coworkers 
also reported that CTGF mRNA expression is increased 10-fold in bronchoalveolar lavage fluid 
in patients with IPF, compared with healthy control subjects (Allen, 1999). Connective tissue 
growth factor in plasma was reported to be elevated in IPF patients and the abundance correlated 
with change in FVC (Kono, 2011). These observations suggest that CTGF may have a role in the 
pathogenesis of IPF. 
1.4 
Investigational Product FG-3019    
FG-3019 is a fully human, recombinant DNA-derived, IgG1 kappa monoclonal antibody that 
binds to CTGF in the N-terminal domain 2, with high affinity (Kd = 0.1–0.2 nM). The antibody, 
which has a molecular weight of approximately 150 kDa and contains 1326 amino acids, has 
been shown to interfere with the activity of CTGF. For additional information on FG-3019, 
please refer to the current Investigator’s Brochure.  
1.5 
Clinical Trial Experience with FG-3019 
The clinical trial experience with FG-3019 includes seven clinical studies that are described in 
the Investigator’s Brochure (Version 13, 18 December 2014). Overall safety experience with 
FG-3019 has been favorable in studies involving subjects with IPF, pancreatic cancer, liver 
fibrosis due to hepatitis B, and diabetic kidney disease.  
In the Investigator Brochure, exposure of subjects to FG-3019 is displayed in Table 1. Twenty 
one subjects with IPF received a single dose of FG-3019, 89 subjects with IPF received multiple 
doses in an open label trial, and 27 subjects with IPF have received multiple doses of blinded 
study drug (FG-3019 or placebo) in the current trial Overall, FG-3019 has been well tolerated. 
Adverse events (AEs) have been generally mild or moderate in severity and transient in duration. 
The AEs have been typical of the subjects’ underlying medical condition(s) and, in placebo-
controlled studies, were equally distributed between the placebo and FG-3019 treatment groups. 
Infusions of FG-3019 have been well tolerated. No infusion has been stopped due to AEs. There 
is no apparent pattern to the SAEs observed during clinical trials, and all SAEs, except one case 
of pain in extremity, were considered by the Sponsor as unrelated to study drug. See the 
Investigator Brochure for additional information. 

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1.6 
Rationale for FG-3019 in Idiopathic Pulmonary Fibrosis 
The observations that CTGF is a central mediator in the process of fibrosis suggest a potential 
role for FG-3019 in interfering with the activity of CTGF and thereby preventing or reversing 
fibrotic lung damage in IPF. Connective tissue growth factor is considered a potential target for 
therapeutic intervention in pulmonary fibrosis (Antoniou, 2007, Ask, 2006, Blom, 2002, 
Bonniaud, 2004, Grotendorst, 1997).  
A murine model of chronic lung fibrosis demonstrated that FG-3019 attenuated 
radiation-induced lung remodeling (Huber, 2010). In mice treated with FG-3019 for 8 weeks 
starting 3 or 16 weeks after irradiation, no tissue remodeling or fibrosis was observed 30 weeks 
after irradiation, and lung function, as measured by partial pressure of oxygen in arterial blood, 
was normalized compared with mice in the irradiated control groups. Mice treated with FG-3019 
starting 16 weeks after irradiation displayed a significant reversal of lung density, which was 
measured by computed tomography. FG-3019 also improved survival in most groups that 
received FG-3019. Mice that received FG-3019 starting 3 weeks after irradiation had a survival 
rate of 70% at the end of the study (48 weeks after irradiation) compared with 0% survival in the 
irradiated controls (Huber, 2010). In another study, administration of FG-3019 to mice with 
bleomycin-induced pulmonary fibrosis significantly inhibited lung hydroxyproline content, a 
marker of lung collagen content (FibroGen, 2003, data on file). 
These preclinical findings are supported by preliminary efficacy data in the FGCL-3019-049 
study, which suggest that treatment of subjects with IPF with FG-3019 15 mg/kg and 30 mg/kg 
IV every 3 weeks is associated with improvement or stability in quantified scores of whole lung 
fibrosis in approximately 45 percent of subjects at 24 weeks (Raghu, 2012). Changes from 
baseline in these scores were significantly correlated with changes in FVC percent of predicted 
value (Raghu, 2012). In 2012, the FDA granted Orphan Drug Designation to FG-3019 for the 
treatment of IPF. A randomized, double-blind, placebo-controlled trial of FG-3019 30 mg/kg is 
warranted at this time to further assess safety, tolerability, and efficacy in subjects with IPF.  

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2 
OBJECTIVES  
The overall objective of this study is to evaluate the safety and tolerability of FG-3019 in 
subjects with IPF, and the efficacy of FG-3019 for attenuating fibrosis and loss of FVC in these 
subjects. 
2.1 
Primary Safety Objective 
To determine the safety and tolerability of FG-3019 administered at a dose of 30 mg/kg by IV 
infusion every 3 weeks. 
2.2 
Primary Efficacy Objective 
To determine the effect of FG-3019 on FVC (percent of predicted value) when administered at a 
dose of 30 mg/kg by IV infusion every 3 weeks for 45 weeks in the target population. 
2.3 
Secondary Efficacy Objectives 
1. To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis as measured by 
HRCT scans of the chest. 
2. To evaluate the relationship between changes in quantified scores of pulmonary fibrosis 
and clinical outcomes. 
3. To evaluate the effect of FG-3019 on progression of IPF and the frequency of 
respiratory-related hospitalizations and respiratory-related mortality. 
4. To evaluate the effect of FG-3019 on health-related quality of life (HRQoL).  
2.4 
Exploratory Efficacy Objectives 
1. To evaluate the effect of FG-3019 on FVC (liters). 
2. To evaluate the effect of FG-3019 on a panel of serum and plasma biomarkers. 
3. To evaluate the relationship between known chromosomal loci associated with IPF and 
the response to FG-3019. 

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3 
ENDPOINTS AND ASSESSMENTS 
3.1 
Safety Endpoints and Assessments 
• AEs and SAEs 
• Laboratory test abnormalities (graded by NCI Common Terminology Criteria for 
Adverse Events [NCI CTCAE, v4.0]) 
• 12-lead electrocardiograms (ECGs) 
• Physical examinations 
• Human anti-human antibody (HAHA) 
3.2 
Efficacy Endpoints and Assessments 
3.2.1 Primary Efficacy Endpoint 
• Change from baseline in FVC (percent of predicted value) at Week 48. 
3.2.2 Secondary Efficacy Endpoints. 
• Change in pulmonary fibrosis score by quantitative HRCT at Week 24, Week 48, and 
later time points. 
• Change from baseline in HRQoL at Week 24, Week 48, and later time points. 
• Progression of IPF, defined as time from Day 1 to any one of the following: 
o Death from any cause 
o Absolute decline in FVC % of predicted value of ≥10% not due to intercurrent illness, 
confirmed by repeat spirometry.  
o Clinical diagnosis of IPF progression. 
• Proportion of subjects with at least one respiratory-related hospitalization. 
• Proportion of subjects with respiratory-related death, censored at Week 52. 
• Categorical assessment of absolute change from baseline in FVC percent of predicted 
value at Week 48. 
3.2.3 Exploratory Efficacy Endpoints  
• Change from baseline to Week 24 and from baseline to Week 48 in FVC (liters). 
• Change from Day 1 to Week 48 in a panel of serum and plasma biomarkers that will be 
determined by FibroGen. 
• Relationship between known chromosomal loci associated with IPF and the response to 
FG-3019. 

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4 
STUDY DESIGN 
4.1 
Study Population 
Male or female subjects, 40 to 80, years old who have IPF diagnosed in accordance with criteria 
published in the 2011 international consensus guidelines. Subjects who have failed or are 
intolerant of products approved for treating IPF are eligible. 
4.2 
Description of the Study 
This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study. Subjects who 
have failed or are intolerant of products approved for treating IPF are eligible. Other subjects 
must be fully informed of the potential benefits of approved products and make an informed 
decision that they prefer to participate in a clinical trial in which they may be randomized to 
placebo. 
Subjects who sign informed consent will undergo screening visits to determine their eligibility. 
Eligible subjects will be stratified based on prior therapy with nintedanib and/or pirfenidone 
(yes/no) and randomized (1:1) to one of two treatment arms: 
 
Arm A: FG-3019, 30 mg/kg  
 
Arm B: Matching placebo 
Approximately 60 centers in the United States and other countries will participate in this clinical 
trial. 
4.2.1 Study Periods 
There are four study periods: 
• Screening Period (up to 6 weeks) 
• Randomized Treatment Period (48 weeks) 
• Extended Treatment Period (sub-set of subjects [see definition above]; duration based on 
changes in FVC (Section 4.2.3) 
• Follow-Up Period (all subjects will undergo a final safety assessment at 4 weeks after last 
dose of study drug.) 
A schematic overview of the trial is provided in Figure 1.  
 
 
 
 
 
 
 
 

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Figure 1. 
Study Schema 
 
4.2.2 Randomized Treatment Phase 
Treatment should begin within 42 days of the first screening visit. Study Drug (FG-3019 
[30 mg/kg] or placebo) will be administered by IV infusion every 3 weeks for a total of 
16 infusions over 48 weeks.  
The schedule of assessments of safety and efficacy are provided in Appendix 1 and Appendix 2. 
Safety and tolerability will be monitored closely by FibroGen. Cumulative safety experience will 
be evaluated by FibroGen on a regular basis. Final efficacy assessment is in Week 48. Subjects 
who do not enter the Extended Treatment Phase will undergo end-of-study (EOS) assessment 
(Appendix 3) on Week 49 (4 weeks after last dose of study drug). 
After all subjects complete Week 48 evaluations or prematurely discontinue the study, data will 
be cleaned and locked for the primary analysis of efficacy and safety.  
4.2.3 Extended Treatment Period (Weeks Identified with –EX Suffix) 
At the time of roll over into the Extended Treatment Period, the study subject treatment 
assignment will be unblinded only to designated personnel not associated with the study at 
FibroGen Inc. To continue to maintain the study blind, the first dose for all subjects in the 
Extended Treatment Period will be administered over approximately 2 hours. 
 
4.2.3.1 Subjects Enrolled under the Original Protocol and Assigned to Arm A: FG-3019 
All subjects in Arm A whose FVC percent predicted value shows less than 3% absolute decrease 
from baseline in the Randomized Treatment Period will be offered participation in an Extended 
Treatment Period. These subjects may continue treatment until FVC percent predicted decreases 
3% or more on two consecutive scheduled evaluations compared to the original pre-treatment 
baseline. 
 
Screening 
Period 
Randomize 
1:1
FG- 3019 
48 - Week 
Blinded 
Treatment 
Phase 
Extended 
Treatment Phase 
Assessment at 
Wk 48 (or early 
termination) 
Placebo 
All FG-3019 
Subjects
Week 49 End-of-
study visit  
All Placebo 
Subjects 
Yes
No
≥ 
l≤0% change 
FVC% predicted 

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4.2.3.2 Subjects Enrolled Under Amendment 1 or Subsequent Amendments and Assigned 
to Arm A: FG-3019 
All subjects in Arm A whose FVC percent predicted value is greater than the original pre-
treatment baseline in the Randomized Treatment Period will be offered participation in an 
Extended Treatment Period and may continue treatment until FVC percent predicted is equal to 
or less than the pre-treatment baseline on two consecutive scheduled evaluations. 
 
4.2.3.3 Subjects Enrolled Under the Original Protocol or Amendment 1 and Subsequent 
Amendments Assigned to Arm B: Placebo 
All subjects assigned to Placebo (Arm B) will be offered participation in the Extended Treatment 
Phase for 45 weeks. Placebo subjects in the extension study are treated identically to subjects 
randomized to FG-3019 in Amendment 1, except for the fact that the baseline for these patients 
is the time at which they are enrolled into the extension phase (Baseline for Placebo subjects is 
Week 48 value). Change in FVC percent predicted during the extended treatment phase will be 
compared to this new baseline. Those subjects whose FVC percent predicted value  is either 
equal to or greater than the new baseline may continue treatment with FG-3019 until FVC 
percent predicted is equal to or less than the baseline on two consecutive scheduled evaluations. 
See Section 4.2.3 for details regarding the Extended Treatment Period. 
4.2.4 End of Treatment and Follow-up 
4.2.4.1 Randomized Treatment Phase 
• Subjects assigned to either FG-3019 or placebo who discontinue treatment before week 
48 should undergo end of treatment and safety assessment visits (Appendix 3). 
• Subjects who were assigned to FG-3019 complete 48 weeks of treatment and are not 
going on to the Extended Treatment Period should undergo a Safety Assessment visit 
(Appendix 3); Week 48 evaluation is identical to End of Treatment visit. Thus, subjects 
who complete Week 48 and are not eligible for the extension study only need the final 
safety assessment. Subjects who enter the Extended Treatment Period do not need a final 
safety assessment because they are continuing treatment). 
• Subjects who were assigned to placebo who complete 48 weeks of treatment but do not 
enter the Extended Treatment Period should undergo a safety assessment as described in 
Appendix 3. 
4.2.5 Extended Treatment Phase 
• Subjects who were assigned to FG-3019 and continue in the Extended Treatment Period 
will undergo early termination and safety assessment visits (Appendix 3) at the time they 
discontinue treatment unless they discontinue treatment at Week 48 EX. In this case, they 
only undergo the safety assessment visit. This is applicable whether subjects stop before 
or after week 48 EX.  
• Subjects who were assigned to placebo, and receive FG-3019 in the Extended Treatment 
Phase and then discontinue treatment at Week 48 of the Extended Treatment Period 
should undergo a Safety Assessment visit (Appendix 3).  
 

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• Subjects who were assigned to placebo, and receive FG-3019 in the Extended Treatment 
Phase who discontinue treatment prior to Week 48 of the extended treatment period will 
undergo early termination and safety assessment visits (Appendix 3) at the time they 
discontinue treatment.  
4.2.6 Placebo Control Group 
In order to evaluate the effect of treatment with FG-3019 on the endpoints described in 
Section 3, approximately 50% of subjects will be randomized to placebo treatment (Arm B). 
The placebo control is appropriate for this trial given the population of participating subjects. 
Enrolled subjects are those who have failed or are intolerant of approved therapies and who 
refuse to receive approved therapies. For these subjects the only treatment option is best 
supportive care, which is available to them within this protocol, and optionally experimental 
treatment. Therefore, placebo control, which provides for the best supportive care, is appropriate 
and ethical. Additionally, subjects who are randomized to placebo will be offered crossover 
treatment to the active arm after completion of the initial 48-week treatment period. 
4.3 
Treatment Assignment 
Subjects are stratified by prior therapy with pirfenidone and/or nintedanib (yes/no) and 
randomized 1:1 to FG-3019 or placebo using an Interactive Web Response System (IWRS). 
4.4 
Blinding 
4.4.1 Rationale for Blinding 
Blinded treatment with a placebo control is the gold standard method for obtaining unbiased 
assessments of safety and efficacy in clinical trials of investigational drugs such as FG-3019. 
4.4.2 Maintenance of Blinding 
A statistician who is not otherwise affiliated with the study prepared the randomization code and 
the code is not available to study staff. The subjects, clinical site staff, and the FibroGen Medical 
Monitor and Clinical Operations staff will be blinded to whether a subject is randomized to 
FG-3019 or placebo. Study drug (FG-3019 or placebo) are provided in coded vials that are 
identified by serial number only. 
4.4.3 Unblinding of Treatment Assignment 
Treatment assignment of individual subjects will be unblinded during the study if this 
information is required to manage a SAE. Study documentation provides details on the 
procedures for unblinding treatment assignment by investigators. For planned assessments of 
efficacy, treatment assignment by groups will be unblinded but individual subject treatment 
assignments will not be unblinded. Treatment will be unblinded for each subject after completion 
of the Week 48 evaluations by unblinded FibroGen personnel. Subject eligibility for the 
Extended Treatment Phase will be communicated to the site. 
Unblinding will also occur at the time of enrollment of subjects into the at Extended Treatment 
Period, after all week 48 assessments are complete only for designated individuals at FibroGen 
Inc. who are not associated with the conduct of this study. The Investigators, subjects and study 
teams will remain blinded till the study is complete. 

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4.5 
Study Treatment with FG-3019 
Subjects will receive FG-3019 at a dose of 30 mg/kg by IV infusion in normal saline  (unless 
volume is >250mL in which case the study drug can be administered undiluted)  every 3 weeks. 
The maximum dose of FG-3019 at any infusion will be capped at 3,900 mg. 
4.6 
Concomitant Medications, Procedures and Nondrug Therapies 
4.6.1 Concomitant Medications 
Concomitant medications (any prescription and/or over-the-counter [OTC] preparation) and 
procedures or nondrug therapies (e.g., physical therapy, acupuncture, continuous positive airway 
pressure [CPAP]) used by a subject while participating in this clinical trial must be recorded 
from Screening Visit 1 through the End-of-Study (EOS) Visit.  
Other than the restrictions that follow, concomitant medications may be given at the discretion of 
the Investigator. It is expected that Investigators will provide optimal medical management of 
idiopathic pulmonary fibrosis and that subjects may be treated with concomitant medications for 
their various medical conditions. Optimal medical care must be provided, and Investigators 
should ensure, for example, that subjects maintain stable vital signs and laboratory test values 
during the course of the study. 
Oral prednisone or equivalent oral corticosteroid (up to 10 mg daily) and NAC (up to 1800 mg 
daily) will be allowed during the study. 
Prohibited medications include approved or investigational agents for the treatment of interstitial 
lung diseases including IPF. The list of prohibited concomitant medications for treatment of IPF 
includes, but is not limited to, the following: sildenafil, pirfenidone, nintedanib, azathioprine, 
cyclophosphamide, cyclosporine, interferon gamma 1b, D penicillamine, methotrexate, 
leflunomide, colchicine, bosentan, ambrisentan, aminobenzoate, mycophenolate mofetil, 
imatinib, relaxin, etanercept, adalimumab, infliximab, anakinra, abatacept, and rituximab. If 
sildenafil is used for erectile dysfunction the dosage regimen should be no more than three times 
a week. Immunosuppressives and monoclonal antibodies used for other diseases such as 
rheumatoid arthritis are allowed but the indication should be clearly documented. Indications for 
concomitant medications should be clearly documented in the subjects clinical record (use for 
IPF or other diseases). 
Any medications to treat IPF should be terminated within 5 half-lives of Day 1 dosing. If 
monoclonal antibodies are used the last dose must be at least 4 weeks before Day 1 dosing 
(Exclusion criterion 15). 
Questions about concomitant medications should be addressed to the attention of the FibroGen 
Medical Monitor or designee. 
4.6.2 Contraception 
Female subjects of childbearing potential and male subjects with female partners of childbearing 
potential are required to use double barrier contraception methods during the conduct of the 
study and for 3 months after the last dose of study drug.  
Pregnancy, spontaneous or therapeutic abortion, or events related to pregnancy must be reported 
(Section 11.3.6). 

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4.7 
Safety Plan 
Safety will be assessed throughout the study. A medically complete baseline profile of each 
subject will be established through medical history, a complete physical examination including 
vital signs, laboratory tests, PFTs, and a 12-lead ECG. During the course of the study, vital signs, 
complete and focused physical examinations, laboratory tests, and PFTs will be performed at 
frequent intervals as described in Appendix 1 and Appendix 2. Any medically significant 
changes from baseline will be monitored throughout the study and appropriate interventions will 
be taken accordingly. Safety and tolerability will be monitored closely by FibroGen.  
4.8 
Independent Data Monitoring Committee 
4.8.1 Safety Monitoring 
Safety data in this double-blind placebo-controlled study will be monitored on a regular basis by 
a Data Monitoring Committee (DMC) that is independent of the FibroGen Medical Monitor and 
Clinical Operations staff. FibroGen is responsible for the establishment of this DMC, the 
development of a DMC charter, and supporting DMC meetings. 

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5 
ELIGIBILITY CRITERIA 
FibroGen will not grant waivers to Inclusion Criteria and Exclusion Criteria in this protocol. 
5.1 
Inclusion Criteria 
1. Age 40 to 80 years, inclusive. 
2. Diagnosis of IPF as defined by current international guidelines (Raghu, 2011). Each 
subject must have one of the following: (1) Usual Interstitial Pneumonia (UIP) Pattern 
on an available HRCT scan; or (2) Possible UIP Pattern on an available HRCT scan and 
surgical lung biopsy within 4 years of Screening showing UIP Pattern (HRCT criteria for 
UIP Pattern and Possible UIP Pattern and histopathological criteria for UIP Pattern 
described in Appendix 4). 
3. History of IPF of ≤5 years duration with onset defined as the date of the first diagnosis of 
IPF by HRCT or surgical lung biopsy. 
4. Interstitial pulmonary fibrosis defined by HRCT scan at Screening, with evidence of 
≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the 
whole lung, as determined by the HRCT central reader. 
5. FVC percent of predicted value ≥55% at Screening. 
6. Female subjects of childbearing potential (including those <1 year postmenopausal) and 
male subjects with female partners of childbearing potential, must use double barrier 
contraception methods during the conduct of the study, and for 3 months after the last 
dose of study drug.  
5.2 
Exclusion Criteria 
1. Female subjects who are pregnant or nursing. 
2. Infiltrative lung disease other than IPF, including any of the other types of idiopathic 
interstitial pneumonias (Travis, 2013); lung diseases related to exposure to fibrogenic 
agents or other environmental toxins or drugs; other types of occupational lung diseases; 
granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including 
vasculitis and connective tissue diseases.  
3. HRCT scan findings at Screening are inconsistent with UIP Pattern, as determined by the 
HRCT central reader (a definition of Inconsistent with UIP Pattern is provided in in 
Appendix 4). 
4. Pathology diagnosis on surgical lung biopsy is anything other than UIP Pattern, as 
determined by the local pathologist (Appendix 4). 
5. The Investigator judges that there has been sustained improvement in the severity of IPF 
during the 12 months prior to Screening, based on changes in FVC, diffusing capacity of 
the lung for carbon monoxide (DLCO), and/or HRCT scans of the chest. 

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6. History of other types of respiratory diseases including diseases or disorders of the 
airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in 
the opinion of the Investigator, would impact the endpoints in the protocol or otherwise 
preclude the subject’s participation in the study. 
7. History of any other respiratory, cardiovascular, renal, hepatic, metabolic, neurologic, 
hematologic, or other medical conditions that, in the opinion of the Investigator, would 
preclude the subject’s participation in the study. 
8. Clinically important abnormal laboratory tests (including serum creatinine ≥1.5 x upper 
limit of normal [ULN], hemoglobin (Hb) <10 g/dL, white blood cells <3,000/mm3, 
platelets less than 100,000/mm3, serum total bilirubin >1.5 x ULN, serum alanine 
aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN, or serum 
alkaline phosphatase ≥2 x ULN. 
9. Upper or lower respiratory tract infection of any type within 4 weeks of Screening. 
10. Acute exacerbation of IPF within 3 months of Screening (a definition of acute 
exacerbation of IPF is provided in Section 8. 
11. Evidence of obstructive lung disease by any of the following criteria: forced expiratory 
volume in 1 second/forced vital capacity (FEV1/FVC) ratio <0.70, or extent of 
emphysema on HRCT greater than the extent of fibrosis on HRCT. 
12. DLCO <30% of the predicted value. 
13. High likelihood of lung transplantation (in the opinion of the Investigator) within 6 
months after Day 1. 
14. Poorly controlled chronic heart failure; clinical diagnosis of cor pulmonale requiring 
specific treatment; or severe pulmonary hypertension requiring specific treatment that, in 
the opinion of the Investigator, would preclude the subject’s participation in the study.  
15. Use of medications to treat IPF within 5 half-lives of Day 1 dosing. If monoclonal 
antibodies were used, the last dose of the antibody must be at least 4 weeks before Day 1 
dosing. 
16. Use of any investigational drugs, including any investigational drugs for IPF, within 
4 weeks prior to Day 1 dosing. 
17. History of cancer diagnosis of any type in the 3 years preceding Screening, excluding 
non-melanomatous skin cancer, localized bladder cancer, or in situ cancers.  
18. Clinically significant trauma or surgical procedures within 4 weeks prior to dosing. 
19. Planned elective surgery during the study including 4 weeks following the final dose of 
Study Drug. 
20. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine 
monoclonal antibodies. 
21. The Investigator judges that the subject will be unable to fully participate in the study and 
complete it for any reason, including inability to comply with study procedures and 
treatment, addiction, or any other relevant medical or psychiatric conditions. 
22. Body weight >130 kg. 

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23. Previous treatment with FG-3019. 
24. Inadequate IV access. 

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6 
STUDY DRUG/TREATMENT SUPPLY 
6.1 
FibroGen Investigational Product 
FG-3019 is a fully human IgG1 kappa monoclonal antibody that binds to CTGF. It will be 
administered at a dose of 30 mg/kg by IV infusion in a total volume of 250 mL (up to 400 mL if 
necessary) normal saline every 3 weeks. The maximum dose of FG-3019 will be capped at 
3,900 mg. Labels will be prepared in accordance with Good Manufacturing Practice and local 
regulatory guidelines. The labels will fulfil Good Manufacturing Practice Annex 13 requirements 
for labelling. Label text will be translated into local language. 
The patient emergency contact details will not be on the label, but can be found in the informed 
consent.  
6.1.1 Formulation 
FG-3019 is supplied in single-use glass vials containing 10 mL of a sterile, preservative-free 
solution. The solution is composed of 10 mg/mL FG-3019, 1.60 mg/mL l-histidine, 3.08 mg/mL 
l-histidine HCl, 8.01 mg/mL sodium chloride and 0.05 mg/mL polysorbate 20, resulting in a 
solution with a tonicity of approximately 290 mmol/kg and a pH of 6.0.  
6.2 
Reference Therapy (Placebo) 
Placebo (identical to the FG-3019 vehicle) is handled and administered in a manner that is 
identical to FG-3019.  
6.2.1 Formulation 
Placebo is a sterile, aqueous solution of pH 6.0 for dilution into 0.9% serum chloride injection 
USP prior to IV infusion. The solution formulation contains 8.01 mg/mL sodium chloride, 
3.08 mg/mL L-histidine HCL, 1.60 mg/mL L-histidine, and 0.05 mg/mL polysorbate 20. The 
solution is free of preservatives as the content of each vial is intended for single use. Each vial 
delivers a nominal volume of 10 mL.  
6.3 
Preparation of Dose and Administration  
The dose of Study Drug (FG-3019 [30 mg/kg] or placebo) for each infusion will be based on the 
Day 1 weight for the first 12 weeks. Total volumes of <250 mL must be diluted in 0.9% Sodium 
Chloride Injection according to the Dose Preparation Instructions in the Study Reference 
Manual. Total volumes of >250 mL FG-3019 can be infused undiluted. The dose should be 
prepared in a volume of fluid that does not exceed 400 mL. Study Drug will be administered as 
soon as possible after release from the site’s pharmacy and within 8 hours of preparation. Study 
Drug will be administered by IV infusion, using an infusion set with a sterile, nonpyrogenic, 
low-protein-binding in-line filter (0.2-micron pore size).  
The first administration of Study Drug in any given subject in the Randomized Treatment Period 
as well as the Extended Treatment Period shall be completed in approximately 2 hours. If the 
first administration is well tolerated and no drug-related AEs are observed during the infusion or 
subsequent 1-hour observation period, the second administration of Study Drug shall be 
completed in approximately 1 hour. All subsequent infusion periods, including those in the 
Extended Treatment Phase, may be shortened to approximately half an hour. If a drug-related AE 
occurs during the first or a subsequent infusion, Study Drug will be administered over 

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approximately 1 hour for the next three infusions. If no drug-related AEs are observed in any of 
these three infusions, the duration of infusion may be decreased to approximately half an hour.  
A physician must be immediately available during the first Study Drug infusion and observation 
period for each subject. If a subject has a significant infusion reaction, the infusion rate may be 
slowed or temporarily stopped, depending on the severity of symptoms. If a subject experiences 
a significant infusion reaction and continues Study Drug dosing, a physician should be 
immediately available during all subsequent infusions and observation periods. If the 
Investigator wishes to use premedication, e.g., antihistamines, nonsteroidal anti-inflammatory 
drugs (NSAIDs) for a subsequent infusion, this should be discussed with the FibroGen Medical 
Monitor or designee. Infusions are to be continued until the total volume of the infusion has been 
administered. Subjects will remain at the study site for 1 hour after the end of the infusion for 
clinical observation. The post-infusion observation period may be reduced to 30 minutes if the 
subject has had no infusion-related AEs after three infusions. The IV line should remain in place 
and maintained per site procedures until the end of this post-treatment observation period.  
Study Drug will be administered at a hospital or ambulatory setting with adequate facilities for 
managing medical emergencies. Medications for the treatment of acute reactions, including 
anaphylaxis, must be available to study site staff for immediate use. There is no specific 
treatment for an FG-3019 overdose or infusion reaction. Signs and symptoms should be managed 
with appropriate standard of care treatment.  
The following procedures must be performed during each infusion: 
Vital signs (blood pressure [BP], pulse, respiration rate, and temperature) every 30 minutes 
(± 10 minutes) 
Query subject and assess AEs and SAEs  
Record concomitant medications, including any pre-medication pre-approved by the FibroGen 
medical monitor or designee 
The following procedures must be performed after each infusion: 
Vital signs (BP, pulse, respiration rate, and temperature) every 30 minutes (± 10 minutes) for a 
minimum of 30 minutes after completion of the infusion (see above) 
Query subject and assess AEs and SAEs 
Record concomitant medications 
6.4 
Storage  
Vials of Study Drug must be stored refrigerated (2°C to 8°C), temperature-controlled and 
monitored, protected from light and in a securely locked area to which access is limited to 
appropriate study personnel. Documentation of the storage conditions must be maintained by the 
site for the entire period of study participation. 

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7 
STUDY PROCEDURES-ALL COHORTS UNLESS OTHERWISE SPECIFIED 
7.1 
Study Procedures 
The study procedures and assessments are presented for the Randomized Treatment phase in 
Appendix 1, for the Extended Treatment phase in Appendix 2, and for End-of-Treatment and 
Follow-up periods in Appendix 3. See the Study Reference Manual for additional details. 
The treatment period in the Randomized Treatment Phase begins on Day 1 (first infusion of 
Study Drug) and continues through Week 48. Visit windows are within ± 3 days of the scheduled 
visit date for Weeks 3 through 48. 
After completion of Week 48 assessments and reporting of all AEs, subjects may be eligible to 
continue to open label treatment in the Extended Treatment Phase. All other subjects undergo the 
EOS assessments. 
Eligible subjects from the Randomized Treatment Phase of the study are offered participation in 
the Extended Treatment Phase as described under Section 4.2.3 and illustrated in Figure 1. A 
Transition Period of up to 3 weeks between the Week 48 Visit in the Randomized Treatment 
Period and Day 1-EX in the Extended Treatment Phase is provided in order to determine subject 
eligibility for the Extended Treatment Phase and to arrange scheduling of the Day 1-EX Visit. 
The total interval between the Week 45 Visit in the Randomized Treatment Phase and the Day 
1-EX Visit in the Extended Treatment Phase should not exceed 6 weeks. If necessary, an 
unscheduled visit should be performed to obtain repeat pulmonary function tests (FVC) if the 
interval between the Week 45 Visit in the Randomized Treatment Phase and the Day 1-EX Visit 
in the Extended Treatment Phase is expected to exceed 6 weeks.  
The treatment period in the Extended Treatment Phase begins on Day 1-EX (first infusion of 
FG-3019) and continues until progression or withdrawal. Visit windows are within ± 3 days of 
the scheduled visit date.  
7.2 
Serial PFT and HRCT 
The key study procedures that measure efficacy are serial PFT measurements to look at 
spirometry (see Procedure Manual for PTF for additional details) and serial HRCT assessments 
to look for fibrosis (see Site Manual for HRCT and Appendix 5). 
7.3 
Blood Volume 
The total amount of blood taken is approximately 13 tablespoons (195 ml) in the Randomized 
Treatment Phase and 10 tablespoons (150 ml) per year in the Extended Treatment Phase (total 23 
tablespoons (345ml) for two years. Subjects who continue Extended Treatment beyond one year 
will give approximately 150 mL of blood per year.  
7.4 
Missed Visits 
Every attempt should be made to complete all study visits within window as outlined in the 
Schedule of Assessments (Appendix 1, Appendix 2, and Appendix 3).  
Scheduled visit dates are determined from the time of the first dose, which is defined as Day 1. 
Protocol-defined visits conducted outside the ± 3 day study visit window will be recorded as a 
protocol deviation unless there is an AE/SAE/intercurrent illness. If a dose is delayed due to an 
AE/SAE/illness, the next dose should occur as soon as possible when the patient is stable so that 

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the dosing interval is close to 3 weeks. No subject should receive more than one dose in any 
7-day period. Missed doses are not to be made up through undertaking extra visits. If a subject 
misses more than two infusions in any 18-week period throughout the study, or two sequential 
infusions, the FibroGen Medical Monitor should be notified. Subjects who miss three sequential 
doses or more than one instance of two sequential doses will not be allowed to continue in the 
study and will be terminated early. The reason for missed doses should be documented in the 
subject’s clinical record. 
For missed visits without an AE/SAE/intercurrent illness, the subject will be asked to resume the 
planned visit schedule and return for the next scheduled visit. If the subject is unable to perform 
PFTs at a scheduled visit the PFT can be performed at the next scheduled visit. 
Refer to the case report form (CRF) completion guidelines in the Study Reference Manual for 
additional information on CRF completion requirements for missed visits.  
7.5 
Unscheduled Visits 
Unscheduled Visit assessments may be required at the discretion of the Investigator. These 
should be recorded on the appropriate CRF. 
Subjects who, in the judgment of the PFT technician or investigator, are unable to perform PFTs 
adequately on a scheduled visit should undergo PFT assessment at the next scheduled visit or 
sooner if feasible. 
7.6 
Assessments 
7.6.1 Central Laboratory 
All laboratory tests of blood and/or urine specimens will be performed by a central laboratory or 
FibroGen, as appropriate. A Central Laboratory Manual with instructions on specimen 
collection, processing, storing, and shipping to the central laboratory will be provided to all 
participating sites. 
7.6.2 Local Laboratory(s) 
A local laboratory will analyze urine (and blood, if necessary) samples for pregnancy testing 
only. 
7.6.3 Other Reference Laboratories 
Human anti-human antibody plasma level measurement will be performed at a specialty 
laboratory. 
7.6.4 Exploratory Biomarkers 
Serum and plasma samples will be stored and used to explore additional biomarkers of 
FG-3019’s effects. The final selection of these biomarkers will be made by FibroGen, based 
upon the best scientific data available at that time. 
7.6.5 DNA for Genomic Analysis 
Fingerlin et al performed a genome-wide association study in subjects with fibrotic idiopathic 
interstitial pneumonias (N = 1616) and controls (N = 4683) (Fingerlin, 2013) and determined an 
association of disease with TERT and MUC5B on chromosomes 5p15 and 11p15, respectively, 
the chromosome 3q26 region near TERC, and identified 7 novel chromosome loci. The novel 
loci include FAM13A (4q22), DSP (6p24), OBFC1 (10q24), ATP11A (13q34), DPP9 (19p13), 

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and chromosomal regions 7q22 and 15q14-15. Their findings indicate that genes involved in host 
defense, cell-cell adhesion, and DNA repair contribute to the risk of fibrotic pulmonary disease. 
In this study, we plan to collect whole blood samples to isolate patient DNA and evaluate the 
relationship between clinical response to FG-3019 and variants in these specific chromosomal 
loci. 
A whole blood sample will be collected for DNA analysis on Day 1 before dosing or at 
subsequent visits for subjects already enrolled in the study who agree to DNA analysis. This 
testing is optional, requires specific consent by participating subjects and subjects may refuse 
DNA testing. Only tests for genetic loci associated with IPF will be performed and all samples 
will be destroyed after testing is completed. 

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8 
SUBJECT DISCONTINUATION 
Subjects who discontinue the study early should be strongly encouraged to complete the 
End-of-Treatment and Follow-up Visit (Appendix 3).  
Subjects may withdraw from the study at any time for any reason, whether during the Screening, 
Treatment, or Follow-up Periods. Completion of efficacy assessments as outlined in Appendix 3 
is discretionary and must be discussed in advance with the FibroGen Medical Monitor.  
The Investigator must remove a subject from study treatment for the reasons below. Removing a 
subject from study treatment is based on the judgment of the Investigator in consultation with the 
FibroGen Medical Monitor. 
• Pregnancy in a female subject 
• AEs, SAEs, repeated hospitalizations, or medical conditions that make further 
participation in the study a risk to the subject.  
• Clear evidence of progression of IPF and or absolute decline in FVC % of predicted 
value of ≥10%  in the absence of an intercurrent illness, documented by two consecutive 
spirometry tests. 
• Receipt of a prohibited medication that cannot be discontinued. 
Dosing may be temporarily suspended up to 4 weeks for:  
• Acute exacerbation of IPF, defined as (1) worsening or newly developed dyspnea as 
reported by the subject (≤30 days); (2) new bilateral ground-glass opacities on HRCT 
superimposed on the UIP abnormalities that defined subject eligibility for the study 
(Section 5.1); and (3) worsening hypoxemia (in the judgment of the Investigator), in the 
absence of pulmonary infection, heart failure, or other identifiable causes for this finding. 
• Any other intercurrent illness that temporarily precludes the subject receiving the study 
drug infusion. 
The reasons for suspension of treatment should be clearly documented in the subject’s clinical 
record. 
8.1 
Replacement of Subjects  
At the Sponsor’s discretion, the number of subjects who are enrolled may be increased to 
account for early dropouts if the dropout rate is projected to be greater than 10%. 

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9 
STUDY TERMINATION BY FIBROGEN 
FibroGen has the right to terminate this study or to close any site at any time.  
FibroGen may also suspend enrollment temporarily at any time for business or other reasons. 
If the planned interim analysis indicates a lack of efficacy, FibroGen will terminate the Extended 
Treatment Period and dosing will cease for all subjects.  

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10 STATISTICS 
10.1 Sample Size Determination 
This study is planned to enroll approximately 136 subjects, which will include a target of 
110 subjects who are seeking first-line therapy and 26 subjects who failed pirfenidone and/or 
nintedanib treatment. First-line therapy is defined as no prior therapy with pirfenidone/nintedanib 
or <10% relative decrease in FVC % predicted while receiving either pirfenidone or nintedanib. 
Failure of pirfenidone and or nintedanib treatment is defined as having ≥10% relative decrease in 
FVC % predicted during prior pirfenidone/nintedanib treatment. The effect of first-line treatment 
is the primary interest of the study, and is the basis for sample size determination. Assuming a 
10% dropout rate and a common standard deviation of 7.3, a sample size of 55 subjects per arm 
in the primary analysis population provides approximately 80% power to detect a treatment 
difference of 4.2 in change from baseline to Week 48 in percent predicted FVC, using a 
two-sample t-test at the two-sided significance level of 0.05. The expected treatment difference 
is estimated using data from study FG-3019-049 and placebo data from published studies. In 
Study FG-3019-049, a mean decline of 2.8 in % predicted FVC from baseline to Week 48 was 
observed. The expected decline of 7.0 % predicted FVC in the placebo arm is estimated based on 
the weighted average of published studies (Azuma, 2005, Daniels, 2010, Demedts, 2005, King, 
Jr., 2008, King, Jr., 2009, King, Jr., 2011, Meier-Kriesche, 2004, Noble, 2011, Noth, 2012, 
Raghu, 2004, Raghu, 2008, Raghu, 2012, Richeldi, 2011, Taniguchi, 2010, Zisman, 2010).  
Second line therapy patients are evaluated in an exploratory fashion. If the treatment effect in the 
pirfenidone/nintedanib failure group is similar to that in the general population, the two 
subgroups will be combined to achieve higher power.  
10.2 Analysis Populations 
10.2.1 Safety Population 
The Safety Population will consist of all randomized subjects who received any dose of study 
medication. If actual treatment received differs from the randomized treatment arm, the actual 
treatment arm will be used for safety data analysis. 
10.2.2 Full Analysis Set Population 
The Full Analysis Set (FAS) Population will consist of randomized subjects who received at 
least one dose of study drug and have evaluable FVC assessments at baseline and at least one 
evaluable post baseline. The FAS population will be used in the primary analyses of the PFT 
endpoints and other efficacy endpoints except for PFS. 
10.2.3 HRCT Evaluable Population 
The HRCT Evaluable (HE) Population will consist of randomized subjects who have evaluable 
HRCT fibrosis scores at baseline and at Week 24 or at a later time point. The HE population will 
be used in the analyses related to HRCT fibrosis scores. 

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10.3 Statistical Analysis 
10.3.1 General Analysis Methods 
Unless the planned interim analysis at the end of the Randomized Treatment Phase indicates a 
lack of efficacy, the study is completed when the last subject completes the last visit in the 
Extended Treatment Phase. 
Baseline characteristics, safety, and biomarker data will be summarized based on available data 
in the Safety Population, except for the parameters indicated otherwise. The primary efficacy 
analyses will be based on the FAS population, except for the analysis of PFS, which will be 
based on the Safety Population. All safety, efficacy, and exploratory endpoints will be 
summarized by group of actual treatment received. 
All randomized subjects will be included in the data listings. 
Continuous variables will be presented by descriptive statistics: n, mean, standard deviation, or 
standard error, median, minimum, and maximum. Categorical variables will be presented by 
counts of subjects and percentage.  
10.3.2 Subject Enrollment and Disposition 
The total number of subjects who completed or discontinued the study, and reasons for early 
discontinuation will be summarized for all randomized subjects. 
10.3.3 Demographics and Baseline Characteristics 
Demographics and baseline characteristics will be summarized for subjects in different analysis 
populations and subgroups. Baseline data related to safety and efficacy assessments will be 
summarized with the post-baseline data in the corresponding safety and efficacy sections. 
10.3.4 Efficacy Analyses 
The primary efficacy analyses will be performed in subjects in the FAS population except for 
analyses of PFS, which will be based on the Safety Population. Rules of missing data imputation 
will be described in the SAP. Analyses based on observed data will be used for sensitivity 
analyses. 
10.3.4.1  Primary Efficacy Analysis 
The primary analysis will be to compare the treatment arms in change from baseline to Week 48 
in FVC % predicted based on the FAS Population. A rank ANCOVA model will be used, with 
baseline FVC % predicted value as covariate, treatment group, stratification, and treatment by 
stratification interaction as fixed effects. Factors may be eliminated from the model if they are 
insignificant. If the interaction term is significant, the primary analysis will be based on the 
subgroup of subjects on first-line therapy.  
The ranks of the primary endpoint will be based on observed data and on imputed data if 
observed data are not available. A detailed description of the rank assessment will be described 
in the statistical analysis plan. A repeated measures model utilizing all observed data will be used 
for sensitivity analysis. 

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Descriptive summaries of the primary efficacy parameter will include the following: 
1. Median change from baseline by treatment and visit 
2. % of subjects with no decline by treatment and visit 
3. % of subjects with decline ≥10% by treatment and visit 
10.3.4.2 Analyses of Secondary Efficacy Endpoints 
Similar models to those described above will be applied to analyzing changes in other PFT 
parameters, HRCT fibrosis score, and patient-reported outcome.  
10.3.4.3 Analysis of Progression Free Survival 
PFS is defined as the time from randomization to the first occurrence of the following events 
during the study (whichever occurs first): 
1. Death from any cause 
2. Absolute decline FVC percent of predicted value of ≥10% not due to intercurrent illness 
confirmed by repeat spiromeetry 
3.  Clinical diagnosis of progression of IPF 
The analysis of PFS will be based on the Safety Population. If no PFS event is observed during 
the study, then PFS is censored at the last PFT assessment. 
Comparison between treatment arms in PFS will be performed using the Cox regression model 
with adjustment for baseline FVC % predicted value as well as stratification and stratification by 
treatment interaction. 
10.3.4.4 Analysis of IPF DNA Markers 
Exploratory analyses will be performed to evaluate the relationship between clinical response to 
FG-3019 and variants in the chromosomal loci listed in Section 7.6.5 
10.3.5 Safety Analyses 
Treatment-emergent adverse events (TEAEs), defined as new or worsening AEs that occur after 
the first dose of study drug and within 4 weeks of last dose of study drug, will be tabulated to 
examine their frequency, severity, organ systems affected and relationship to study treatment. 
Treatment emergent SAEs and TEAEs leading to study or treatment discontinuation will be 
listed or tabulated separately.  
Clinically significant changes from baseline in vital signs, laboratory tests, physical 
examinations, and ECGs will be identified.  
Human anti-human antibody data will be summarized in a separate report. 
10.3.6 Interim Analyses 
Unblinded analysis of changes in pulmonary function and in pulmonary fibrosis will be 
performed after all subjects have either completed Week 48 assessments or discontinued the 
study early (prior to week 48 of the Randomized Treatment Phase). This analysis may be 
performed before data lock for the primary analysis of safety and efficacy provided the relevant 
pulmonary function and pulmonary fibrosis data are cleaned. If there is a substantial gap in 
completion of enrollment between subjects on first-line therapy and the pirfenidone and or 
nintedanib treatment failures, unblinded subgroup analysis may be performed at different times.  

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10.4 Statistical Analysis Plan 
The SAP will include detailed plans for presenting and analyzing study data, as well as 
documentation of changes in protocol-specified analysis plans.  
 

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11 ASSESSMENT OF SAFETY 
11.1 Background  
Adverse event reports from investigators are the critical building blocks to the development of 
the safety profile of the study drug. Subjects will be asked non-leading questions in general terms 
to determine the occurrence of AEs, according to the schedule outlines in Appendix 1, 
Appendix 2, and Appendix 3. In addition, all AEs reported spontaneously during the course of 
the study will be recorded. The Investigator must immediately (within 24 hours of awareness) 
report to the sponsor all SAEs, regardless of whether the Investigator believes they are related to 
the study drug. 
The definitions of an AE, suspected adverse reaction, adverse reaction, and SAE are describe 
below in accordance with the FDA Final Rule Vol 75, No 188, September 29, 2010, and/or 
Article 18 of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 
2001 and the International Conference on Harmonisation (ICH) E2A guidance.  
11.2 Definitions 
11.2.1 Definition of an Adverse Event (AE) 
An AE can be any unfavorable and unintended sign (e.g., an abnormal and clinically significant 
laboratory finding), symptom, or disease temporally associated with the use of a drug, without 
any judgment about causality. This includes any occurrence that is new in onset or aggravated in 
severity or frequency from the baseline condition, or abnormal results of diagnostic procedures, 
including laboratory test abnormalities. An AE can arise from any use of the drug (e.g., off-label 
use, use in combination with another drug) and from any route of administration, formulation, or 
dose, including an overdose.  
An AE includes medical conditions, signs, and symptoms not previously observed in the subject 
that emerge during the protocol-specified AE reporting period, including signs or symptoms 
associated with an underlying condition that were not present prior to the AE reporting period 
(Section 11.3.1). 
11.2.2 Definition of a Serious Adverse Event (SAE) 
A serious adverse event is any adverse event or suspected adverse reaction that results in any of 
the following outcomes: 
• Death, 
• A life-threatening AEs (i.e., if in the view of the investigator or sponsor, the subject was 
at immediate risk of death at the time of the event). Life-threatening does not refer to an 
event which hypothetically might have caused death if it were more severe, 
• Inpatient hospitalization or prolongation of existing hospitalization, 
• A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions, 
• A congenital anomaly or birth defect, or 
• Other medically important events 

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Based upon appropriate medical judgment, important medical events that may not result 
in death, be life-threatening, or require hospitalization may be considered serious when, 
they may jeopardize the subject or subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an 
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. These 
events must be reported to the sponsor similar to SAEs. 
• A clinical diagnosis of IPF progression and surgical procedures such as lung 
transplantation are expected in this patient population. Data for IPF progression is being 
collected an efficacy endpoint (Sections 3.2.2, 10.3.4.3). However, as these events are 
medically significant and may be associated with hospitalization, so they should be 
reported as SAEs.  
• Other elective surgeries (example knee replacement, haemorroidectomy, mole removal 
etc.) may occur during the study period. They should not be reported as SAEs, but the 
diagnosis that warranted these procedures should be reported (especially if this is a 
worsening of a pre-existing medical history condition). Any complications of such 
procedures should be reported as AE/SAE based on seriousness criteria listed above. 
11.2.3 Definition of a Suspected Adverse Reaction 
Suspected adverse reaction means any AE for which there is a reasonable possibility that the 
drug caused the AE. The term “reasonable possibility” means there is evidence to suggest a 
causal relationship between the drug and the AE. A suspected adverse reaction implies a lesser 
degree of certainty about causality than the term “adverse reaction”. 
11.2.4 Definition of an Adverse Reaction 
An adverse reaction means any AE caused by a drug. 
11.2.5 Special Situations 
Safety events of interest (“Special Situations”) on the medicinal products administered to the 
subject as part of the study (e.g., study drug, comparator, and background therapy) that may 
require expedited reporting and/or safety evaluation include, but are not limited to: 
• Overdose of the medicinal product 
• Suspected abuse/misuse of the medicinal product 
• Inadvertent or accidental exposure to the medicinal product 
• Medication error involving the medicinal product (with or without subject exposure to the 
Sponsor medicinal product, e.g., name confusion) 
• Drug-drug interaction  
11.3 Procedures for Eliciting, Recording, and Reporting Adverse Events 
11.3.1 Adverse Event Reporting Period 
The study period during which all AEs and SAEs must be collected begins after informed 
consent is obtained and ends 4 weeks after the last dose of study drug, except for pregnancy 

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reporting (Section 11.3.6). In addition, all AEs reported spontaneously by the subject to site 
personnel, outside the study period, may be recorded. 
Adverse events will be followed until resolved, stable, or until the subject’s last study visit or lost 
to follow-up. If an AE is not resolved or stabilized at the subject’s last visit, it is up to the 
discretion of the Investigator and study Medical Monitor to determine if further monitoring of 
the event is warranted. 
Adverse events collected prior to dosing of study drug will be considered “non-treatment 
emergent” while those reported after the first dose of study drug and up to 4 weeks after the last 
dose of study drug will be considered “treatment emergent” and will be assessed for relationship 
to study drug. 
11.3.2 Adverse Event Eliciting/Reporting 
During the AE reporting period, study site personnel will query each subject at each visit to 
actively solicit any AE occurring since the previous visit. All AEs will be collected in response 
to a general question about the subject’s well-being and any possible changes from the baseline 
or previous visit, but shall not be specifically solicited. There will be no directed questioning for 
any specific AE. This does not preclude the site from collecting and recording any AEs reported 
by the subject to site personnel at any other time.  
Whenever possible, diagnoses should be recorded when signs and symptoms are due to a 
common etiology, as determined by qualified medical study staff. New indications for 
medications started after informed consent is obtained until 4 weeks after the last dose of study 
drug will be recorded as AEs; recurrence or worsening of medical history problems requiring 
new or changes in concomitant medication, will also be recorded as AEs. Abnormal, clinically 
significant laboratory results, physical examination findings, and ECGs will be recorded as AEs 
if they are deemed by the Investigator to meet criteria. 
The following attributes must be assigned to each AE: 
• Description (Investigator’s verbatim term describing the event) 
• Dates of onset and resolution 
• Severity 
• Relationship to study drug  
• Outcome 
• Action taken regarding study drug 
• Other treatment required 
• Determination of “seriousness” 
11.3.3 Assessing Adverse Event Severity 
Adverse Events, including abnormal clinical laboratory values, should be graded using the 
National Cancer Institute (NCI) Common Terminology Criteria for AE (CTCAE) guidelines 
(Version 4.03; http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-
14_QuickReference_5x7.pdf). For terms not specified as part of NCI CTCAE, the following 
guidelines should be used to determine grade: 

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All AEs will be assessed for severity using the following criteria:   
• Grade 1, Mild: Asymptomatic or mild symptoms which the subject finds easily 
tolerated. The event is of little concern to the subject and/or of little-or-no clinical 
significance; clinical or diagnostic observations only; intervention not indicated. 
• Grade 2, Moderate: The subject has enough discomfort to cause interference with or 
change in some of their age-appropriate instrumental activities of daily living (e.g., 
preparing meals, shopping for groceries or clothes, using the telephone, managing 
money); local or noninvasive intervention indicated. 
• Grade 3, Severe: The subject is incapacitated and unable to work or participate in many 
or all usual activities. The event is of definite concern to the subject and/or poses 
substantial risk to the subject’s health or well-being; Likely to require medical 
intervention and/or close follow-up, including but not limited to hospitalization or 
prolongation of hospitalization. 
• Grade 4, Life-threatening:  The subject was at immediate risk of death from the event 
as it occurred. 
• Grade 5, Death: Death related to AE.  
11.3.4 Assessing the Adverse Event’s Relationship to Study Drug 
Most of the information about the safety of a drug prior to marketing comes from clinical trials; 
therefore, AE reports from investigators are critically important. Moreover, appropriately 
deciding whether the AE meets the definition of a suspected adverse reaction is usually the most 
difficult determination, but it is critical to avoid the miscategorization of the product’s safety 
profile.  
Due to the historical tendency for assessment of relationship to default as possibly related, the 
FDA has issued new guidance that clarifies the intent of the phrase “reasonable possibility” in 
the definition of “associated with the use of the drug.”  Default reporting of individual events as 
possibly related is uninformative and does not meaningfully contribute to the development of the 
product safety profile.  
The Investigator must provide an assessment of the relationship of the AE to study drug in 
accordance with the guidance below. Absence of an alternative cause would not normally be 
considered enough evidence to assess an event as possibly related or related to study drug.  
• Related (Adverse Reaction): 
o Any event for which there is evidence to conclude that the study drug caused the 
event 
• Possibly Related (Suspected Adverse Reaction): 
o A single occurrence of an event that is uncommon and known to be strongly 
associated with drug exposure, such as angioedema, anaphylaxis, 
rhabdomyolysis, Stevens-Johnson syndrome, etc. 
o One or more occurrences of an event that is not commonly associated with drug 
exposure but is otherwise uncommon in the population exposed to the drug, such 
as tendon rupture 

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• Not Related: 
o The event represents the underlying disease (e.g., disease-related symptoms, 
disease progression) 
o The event represents a comorbid condition present at the time the subject entered 
the study that has not worsened 
o The event represents a known adverse reaction associated with a co-medication 
received by the study subject 
o The event is common for the study population (e.g., cardiovascular events in an 
elderly population) 
The Investigator must provide an assessment of the relationship of the event to study drug, as 
this information is very important to monitor the real-time safety of the study drug. However, as 
the manufacturer of the study drug, Beijing FibroGen is responsible for making the final 
causality assessment for individual reports, and for reporting suspected adverse reactions and 
adverse reactions to Health Authorities. 
11.3.5 Reporting Serious Adverse Events on the SAE Report Form 
All SAEs must be reported immediately to the Sponsor and/or its designated safety management 
vendor. 
To report an SAE, the Investigator must fax an SAE Report Form to the Sponsor’s designated 
safety management vendor within 24 hours of becoming aware of the serious event. In case of 
emergency or doubt, the Investigator shall call the Sponsor’s Medical Monitor for guidance. 
Follow-up reports must be submitted in a timely fashion as additional information becomes 
available.  
Full details of the SAE should also be recorded on the medical records and in the CRF. The 
following minimum information is required: 
• Subject number, sex, and age 
• The date of report 
• A description of the SAE (event, seriousness of the event) 
• Causal relationship to the study drug 
Follow-up information for the event should be sent promptly (within 7 days) as necessary. 
For each SAE observed, the Investigator should obtain all of the information available about the 
event, including (but not limited to): hospital discharge diagnoses, hospital discharge note, death 
certificate, appropriate laboratory findings (including autopsies and biopsy results), and clinical 
examinations (including radiological examinations and clinical consultations). 
11.3.5.1 Reporting Serious Adverse Events to the Institutional Review Board/ Independent 
Ethics Committee 
The Investigator is responsible for notifying his/her Institutional Review Board/Independent 
Ethics Committee (IRB/IEC) of SAEs in accordance with local regulations. Sponsor, or its safety 
representative, will provide to the Investigator a copy of any expedited safety reports that it 
intends to file with a regulatory authority.  

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11.3.5.2 Deaths  
For any death or life-threatening event occurring during the subject’s study participation 
regardless of attribution, the Investigator will report the death or life-threatening event 
immediately to the Sponsor’s Medical Monitor. The Investigator must provide an assessment of 
the relationship of the event to the study drug according to the guidance in Section 11.3.4. 
The Investigator should notify FibroGen of any death or other SAEs occurring after a subject has 
discontinued or terminated study participation that may reasonably be related to this study.  
If the death occurred within the SAE collection and reporting period (signed ICF to 28 days after 
last dose), the Investigator must submit the SAE Report Form in the same manner as described 
above in Section 11.3.5. Additionally, the site must complete the appropriate CRF page. This 
includes death attributed to progression of the subject’s underlying disease. 
11.3.6 Pregnancies: Reporting and Follow-up of Subjects 
A pregnancy in a female subject must be confirmed by a positive serum β-HCG test. If a female 
subject becomes pregnant while the subject is receiving study treatment or within 12 weeks after 
the last dose of study treatment, a Pregnancy Report Form must be completed and submitted to 
the Sponsor (by way of its designated safety management vendor) within 24 hours of the 
Investigator learning of the pregnancy. If applicable, a pregnant subject is immediately 
withdrawn from receiving study treatment. The Investigator must follow the pregnancy to 
completion to ascertain both its outcome (e.g., spontaneous miscarriage, elective termination, 
ectopic pregnancy, normal birth or congenital abnormality) and whether any AEs occur.  
Pregnancy itself is not an AE. However, the Investigator should report the information to the 
Sponsor on the designated forms. Pregnancies are followed up to outcome even if the subject 
was discontinued from the study. The outcome of the pregnancy must be reported by the 
Investigator on a Pregnancy Outcome Report Form, which should be sent to the Sponsor and/or 
its designated safety management vendor within 24 hours of the Investigator learning of the 
outcome. 
Pregnancy of the subject’s partners is not considered to be an AE. However, the outcome of all 
pregnancies should if possible be followed up and documented as described. To capture 
information about a pregnancy from the partner of a male subject, the male subject’s partner 
consent must be obtained to collect information related to the pregnancy and outcome (will be 
handled on a case-by-case basis with IRB/IEC approval).  
11.3.7 Abnormal Laboratory Findings 
Laboratory values will be collected throughout the study to assess for safety. The Investigator 
must review and assess all laboratory results in a timely manner, and determine whether the 
abnormal laboratory values, if any, are clinically significant (CS) or not clinically significant 
(NCS), and whether there are associated signs and symptoms. Clinically significant laboratory 
abnormalities will be reported as AEs.  
An abnormal laboratory finding in absence of any other signs or symptoms is not necessarily an 
AE. If the abnormal laboratory finding is accompanied by signs or symptoms, report the signs 
and symptoms as the AE in lieu of the abnormal laboratory value. If a diagnosis is available, 
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Clinically significant laboratory abnormalities after taking study medication that reflect a 
meaningful change from the screening value(s) and that require active management are to be 
considered by the Investigator as AEs (e.g., abnormalities that require study treatment dose 
modification, discontinuation, more frequent follow-up assessments, etc.).  

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12 STUDY MONITORING 
A site must have had a previous pre-qualification site visit conducted to have a combined 
pre-qualification site visit and site initiation visit. Following site pre-qualification and/or 
initiation of the study site, periodic monitoring visits and site closeout visits will be made by 
FibroGen or its designee. The Investigator must provide direct access to, and allocate sufficient 
space and time for, the monitor to inspect subject source records, CRFs, queries, collection of 
local laboratory normal ranges (if applicable), investigational product accountability records, and 
regulatory documents in accordance with GCP and the ICH E6 guideline. 
The purpose of trial monitoring is to verify the following: 
• The rights and well-being of human subjects are protected. 
• The reported data are accurate, complete, and verifiable from source documents. 
• All data are collected, tracked, and submitted by the site to FibroGen or designee, 
including unscheduled and missed assessments. 
The Investigator must also permit the FDA or other applicable regulatory authorities to inspect 
facilities and records pertaining to this study if so requested. If the Investigator is notified of an 
inspection pertaining to this study by the FDA or other applicable regulatory authorities, the 
Investigator must notify FibroGen immediately. 
12.1 Data Quality Assurance 
The following steps will be taken to ensure that the study is conducted by the study site in 
compliance with the study protocol, GCP, and other applicable regulatory requirements:  
• Investigator meeting and/or Investigator site initiation 
• Routine study site monitoring 
• Documented study and system training 
• CRF and query review against source documents 
• Collection of local laboratory normal ranges 
The study site may be audited by FibroGen’s Quality Assurance department or designee. The 
Investigator agrees to make available to the auditor all necessary study personnel (including 
himself/herself), all source documentation, and study subject records related to this trial. The 
Investigator agrees to follow-up to address and/or correct any audit observations promptly. 
12.2 Compliance with Laws and Regulations 
This study will be conducted in accordance with the FDA regulations, the ICH E6 guideline for 
GCP, the Declaration of Helsinki, and applicable local, state, and federal laws, as well as other 
applicable country laws. 
12.3 Audit and Inspection 
Authorized representatives of the Sponsor, a regulatory authority, an IEC may visit the 
investigator site to perform audits or inspections, including source data verification. The 
Investigator will allow the sponsor auditor, regulatory authority or ethics committee 

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representative to inspect the drug storage area, study drug stocks, drug accountability records, 
subject charts and study source documents, and other records relative to study conduct.  
The purpose of an audit or inspection is to systematically and independently examine all 
study-related activities and documents to determine whether these activities were conducted, and 
data were recorded, analyzed, and accurately reported according to the protocol, ICH GCP 
guidelines, and any applicable regulatory requirements. The Investigator should contact the 
Sponsor immediately if contacted by a regulatory agency about an inspection. 
12.4 Data Collection and Handling 
12.4.1 Source Documents 
Source records are original documents, data, and records that are relevant to the clinical trial. The 
Investigator will prepare and maintain adequate and accurate source documents. These 
documents are designed to record all observations and other pertinent data for each subject 
enrolled in this clinical trial. Source records must be adequate to reconstruct all data transcribed 
onto the CRFs and resolved queries. 
12.4.2 Data Collection, Handling, and Verification 
All required data will be entered onto CRFs by authorized site personnel. Data will be entered 
into a validated, clinical database compliant with 21 CFR Part 11 regulations. The database will 
be a secured, password-protected system with full audit trail. 
All subject data will be reviewed by FibroGen and/or designee. Data that appear inconsistent, 
incomplete or inaccurate will be queried for site clarification.  
Adverse events and concomitant medications will be coded using industry standard dictionaries 
(e.g., Medical Dictionary for Regulatory Activities [MedDRA] and World Health Organization 
Drug (WHODrug) dictionaries). 
The Investigator is responsible for reviewing, verifying, and approving all subject data, i.e., 
CRFs and queries prior to study completion. 

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13 HUMAN SUBJECTS 
13.1 Ethical Considerations 
The study will be conducted in accordance with FDA regulations, the ICH E6 guideline for GCP, 
the Declaration of Helsinki, any other applicable regulatory requirements, and IRB requirements. 
13.2 Communication with the Institutional Review Board 
This protocol, the Informed Consent Form, the Investigator’s Brochure, and any information to 
be given to the subject (e.g., subject information sheet, questionnaires) must be submitted to a 
properly constituted IRB by the Investigator for review and approved by the IRB before the 
study is initiated and before any investigational product is shipped to the Investigator. In 
addition, any subject recruitment materials must be approved by the IRB before the material is 
used for subject recruitment.  
The Investigator is responsible for obtaining reapproval by the IRB annually or more frequently 
in accordance with the regulatory requirements and policies and procedures established by the 
IRB. Copies of the Investigator’s annual report and other required report to the IRB and copies 
of the IRB continuance of approval must be furnished to FibroGen. A copy of the signed form 
FDA 1572 must also accompany the above approval letter provided to FibroGen. 
Investigators are also responsible for promptly informing the IRB of any protocol changes or 
amendments, changes to the Investigator’s Brochure, and other safety-related communications 
from FibroGen. Investigators also are responsible for promptly informing the IRB of protocol 
deviations/violations, as required by their IRB. Written documentation of IRB approval must be 
received before the amendment is implemented. 
Investigators must also enter the names of the staff that are involved in the study on the 
Delegation of the Authority form and sign the form (including their responsibilities). This form 
must be updated when responsibilities of the staff change. 
13.3 Informed Consent Form 
No study procedure may be implemented prior to obtaining a signed and dated written Informed 
Consent Form (ICF) from the subject or the subjects legally authorized representative. IRB 
review and approval are required for the ICF. The final IRB-approved ICF must be provided to 
FibroGen for regulatory purposes. 
If there are any changes to the Sample ICF during the subjects’ participation in the study, the 
revised ICF must receive the IRB’s written approval before use and subjects must be 
re-consented to the revised version of the ICF.  
13.4 Subject Confidentiality 
Release of research results should preserve the privacy of medical information and must be 
carried out in accordance with Department of Health and Human Services Standards for Privacy 
of Individually Identifiable Health information, 45 CFR Parts 160 and 164, and the HIPAA. 
Subject medical information obtained as part of this study is confidential and may only be 
disclosed to third parties as permitted by the Informed Consent and HIPAA Authorization Form 
signed by the subject, or unless permitted or required by law. The subject may request in writing 
that medical information be given to his/her personal physician. 

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14 INVESTIGATOR REQUIREMENTS 
The Investigator must be medically qualified to directly supervise the conduct of the trial at his 
or her site. The Investigator agrees to employ qualified staff to participate in the trial. The 
Investigator will permit trial-related monitoring, audits, IRB review, and regulatory 
inspection(s), providing direct access to source data/documents. 
14.1 Study Medication Accountability 
All Study Drug required for completion of this study will be provided by FibroGen. The 
recipient will acknowledge receipt of the drug by returning the appropriate documentation form 
indicating shipment content and condition. Damaged supplies will be replaced. 
Accurate records of all Study Drug received, dispensed, returned, and disposed of by the study 
site according to the Study Reference Manual should be recorded using the Drug Inventory Log. 
14.2 Disclosure of Data 
Data records generated by this study must be available for inspection upon request by 
representatives of the FDA or other regulatory agencies, national and local health authorities, 
FibroGen monitors/representatives and collaborators, auditors, and the IRB for each study site. 
14.3 Study Files and Retention of Records 
The Investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following two categories:  
(1) Investigator’s Study Files, and (2) Subject Clinical Source Documents. 
The Investigator’s Study File commonly contains essential documents, which are defined as 
those documents that individually and collectively permit evaluation of the conduct of the study 
and the quality of the data produced. Examples of such essential documents are as follows: the 
protocol, amendments, CRFs and query forms, IRB approvals correspondence, informed 
consents, drug records, staff curriculum vitae, laboratory accreditation, authorization forms, and 
other appropriate documents and correspondence.  
Subject clinical source documents (usually defined by the project in advance to record key 
efficacy/safety parameters independent of the CRFs) would include (although not be limited to) 
the following:  subject hospitalization records, physician’s and nurse’s (or other study staff’s) 
notes, appointment book, original laboratory reports, ECGs, x-rays, pathology and special 
assessment reports, consultant letters, screening and enrollment eligibility documentation, 
screening and enrollment logs, etc. 
The Investigator shall retain records required to be maintained under 21 CFR 312.62(c) for a 
period of 2 years following the date a marketing application is approved for the drug for the 
indication for which it is being investigated. If no application is to be filed or if the application is 
not approved for such indication, the Investigator shall retain these records until 2 years after the 
investigation is discontinued and the FDA is notified. 
If the Investigator moves or retires, he or she should identify in writing, the designee who will be 
responsible for record keeping. Archived data may be retained on electronic records or similar 
medium provided that a back-up exists and a hard copy is obtainable if required. No records will 
be destroyed without the prior written consent of FibroGen. 

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15 PUBLICATION POLICY 
A detailed explanation of FibroGen’ s publication policy is described in the Clinical Trial 
Agreement. 

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16 REFERENCES 
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17 APPENDICES

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Appendix 1. Schedule of Assessments ─ Randomized Treatment Phase 
Study Period 
Screening 
Period (up to 
6 weeks) 
Treatment Period 
Visit Number 
1 
2a 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
Study Days 
 
Day 1 
pre 
dose 
Day 1 
post 
dose 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Week (± 3 day 
window for Week 3 to 
Week 48) 
Scr 
1 
Scr 
2a 
0 
0 
3 
6 
9 
12 
15 
18 
21 
24 
27 
30 
33 
36 
39 
42 
45 
48 
Signed and Dated Written 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/ Exclusion 
Criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SGRQ 
 
 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Height and Weightb 
Xb 
 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Complete Physical Exam 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Focused Physical Examc 
 
 
X 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
Pulmonary Function Tests 
Xd 
 
Xe 
 
 
 
 
Xe 
 
 
 
Xe 
 
 
 
Xe 
 
 
 
Xe 
CBC with Differential 
X 
 
X 
  
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Serum Chemistry 
X 
 
X  
  
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Spot Urine for Urinalysis 
X 
 
X 
  
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
  
X 
Pregnancy Testf 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
HRCT of Chest 
 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
12-Lead ECG 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
Serum and Plasma 
Biomarkers 
 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
Plasma HAHA 
 
 
X 
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
Whole Blood for DNA 
 
 
X 
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
AEs and SAEsg 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Xg 
Concomitant Medicationsh 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Procedures and Nondrug 
Therapies 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study Drug infusioni 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 

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Study Period 
Screening 
Period (up to 
6 weeks) 
Treatment Period 
Visit Number 
1 
2a 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
Study Days 
 
Day 1 
pre 
dose 
Day 1 
post 
dose 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Week (± 3 day 
window for Week 3 to 
Week 48) 
Scr 
1 
Scr 
2a 
0 
0 
3 
6 
9 
12 
15 
18 
21 
24 
27 
30 
33 
36 
39 
42 
45 
48 
Subject Disposition 
 
 
Xj 
 
Abbreviations: 
AE = adverse event; CBC = complete blood count; DLCO = diffusing capacity of the lungs for carbon monoxide; ECG = electrocardiogram; EX = extended 
(treatment); HAHA = human anti-human antibody; HCG = human chorionic gonadotropin; HRCT = high resolution computed tomography; SAE = serious 
adverse event; Scr = screening visit; SGRQ = Saint George’s Respiratory Questionnaire 
a 
Screening Visit 2 may be combined with Screening Visit 1. 
b 
Height will be measured only once at Screening Visit 1. Weight will be measured every 12 weeks to determine dose for the subsequent 12-week interval. 
c 
Including chest auscultation  
d 
Spirometry (DLCO at first screening test only). 
e 
Spirometry  
f 
Pregnancy tests (performed at Screening Visit 1, pre-dose Day 1, and pre-dose at other times) for women of childbearing potential only:  serum pregnancy test at 
Screening Visit 1; urine pregnancy tests at other visits. A positive urine pregnancy test must be confirmed by serum HCG. 
g 
See Section 11.3.1 for follow-up of AEs. 
h 
Refer to Section 4.6.1 for prohibited concomitant medications. 
i 
Vital signs (blood pressure, pulse, respiration rate, and temperature) must be recorded prior to each FG-3019 infusion. Intra-infusion and post-infusion assessments will 
be performed according to Section 6.3.  
j 
Subjects who do not complete all visits in the Treatment Period will be encouraged to return for the assessments listed in Appendix 3. 
 

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Appendix 2. Schedule of Assessments ─ Extended Treatment Phase 
Study Period 
Treatment Perioda 
Visit Number 
1-EX 2-EX 3-EX 4-EX 5-EX 6-EX 7-EX 8-EX 9-EX 10-EX 11-EX 12EX 13-EX 14-EX 15-EX 16-EX 17-EX 
Study Week (± 3 d 
window for Week 3-EX to 
Week 48-EX) 
0- 
(Day 
1-EX) 3-EX 6-EX 9-EX 12-EX 15-EX 18-EX 21-EX 24-EX 27-EX 30-EX 33-EX 36-EX 39-EX 42-EX 45-EX 48-EX 
SGRQ 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Weightb  
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Complete Physical Exam 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Focused Physical Examc  
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
Spirometry 
 
 
 
 
Xd 
 
 
 
Xd 
 
 
 
Xd 
 
 
 
Xd 
CBC with Differential 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Serum Chemistry 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Spot Urine for Urinalysis 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Pregnancy Teste  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
HRCT of Chest 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
12-Lead ECG 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
Serum and Plasma 
Biomarkers 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
AEs and SAEsf  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medicationsg 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Procedures and Nondrug 
Therapies 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
FG-3019 Infusionh 
X 
X  
X  
X  
X  
X  
X  
X  
X 
X  
X  
X  
X  
X  
X  
X  
X 
Subject Disposition 
Xi 
 
FOOTNOTES ARE ON THE FOLLOWING PAGE 

FG-3019 
Protocol FGCL-3019-067 Amendment 5.1 
FibroGen, Inc. 
Confidential and Proprietary 
Page 70 of 74 
Abbreviations: 
AE = adverse event; CBC = complete blood count; ECG = electrocardiogram; EX = extended (treatment); FVC = forced vital capacity; HAHA = human anti-
human antibody; HCG = human chorionic gonadotropin; HRCT = high resolution computed tomography; SAE = serious adverse event; SGRQ = Saint 
George’s Respiratory Questionnaire. 
a 
The total duration of the study for subjects is indeterminate because subjects in the extension period may continue treatment until they meet stopping criteria 
(Section 4.2.3). Subjects who complete 48 weeks of treatment extension may continue treatment according to this table (beginning in Week 1Ex).  
b 
Weight will be measured every 12 weeks to determine dose for the subsequent 12-week interval. 
c 
Including chest auscultation  
d 
Spirometry  
e 
Pregnancy tests (performed pre-dose Day 1-EX and at other times) for women of childbearing potential only:  urine pregnancy tests at all Extended Treatment Period 
visits. A positive urine pregnancy test must be confirmed by serum HCG. 
f 
See Section 11.3.1 for follow-up of AEs. 
g 
Refer to Section 4.6.1 for prohibited concomitant medications. 
h 
Vital signs (blood pressure, pulse, respiration rate, and temperature) must be recorded prior to each FG-3019 infusion. Intra-infusion and post-infusion assessments will 
be performed according to Section 6.3.  
i 
Subjects who do not complete all visits in the Treatment Period will be encouraged to return for the assessments listed in Appendix 3. 

FG-3019 
Protocol FGCL-3019-067 Amendment 5.1 
FibroGen, Inc. 
Confidential and Proprietary 
Page 71 of 74 
Appendix 3. Schedule of Assessments ─ Early Termination/End of Treatment and Follow-
up Visit 
Assessment 
Early Termination/End of 
Treatmenta 
End of Study 
1. SGRQ 
Xb 
 
2. Vital Signs 
Xb 
X 
3. Complete Physical Exam 
Xb 
 
4. Spirometry 
Xb,c 
 
5. CBC with Differential 
Xb 
 
6. Serum Chemistry 
Xb 
 
7. Spot Urine for Urinalysis 
Xb 
 
8. Pregnancy Testd 
Xb 
X 
9. HRCT of Chest 
Xb 
 
10. 12-Lead ECG 
Xb 
 
11. Serum and Plasma Biomarkers 
Xb 
 
12. Plasma HAHA 
 
X 
13. AEs and SAEse  
Xb,e 
Xb,e 
14. Concomitant Medicationsf 
Xb 
X 
15. Procedures and Nondrug 
Therapies 
Xb 
X 
16. Subject Disposition 
X 
X 
Abbreviations: 
AE = adverse event; CBC = complete blood count; ECG = electrocardiogram; HAHA = human 
anti-human antibody; HCG = human chorionic gonadotropin; HRCT = high resolution computed 
tomography; PFT = pulmonary function test; SAE = serious adverse event; SGRQ = Saint 
George’s Respiratory Questionnaire. 
a 
End of treatment, including due to withdrawal/progression evaluation preferably 3 weeks after last dose of 
study drug for all subjects who have received more than 4 doses of FG-3019. The End of Study, final safety 
assessment should be 4 weeks after last dose of study drug. Study windows are ± 3 days 
b 
Subjects who completed the withdrawal/progression evaluations at Week 48 or for early withdrawal do not 
need to repeat them. Study endpoint evaluations do not require repetition if performed within 8 weeks, 
HRCT does not require repetition if performed within 4 months, and safety assessments, such as clinical 
laboratory tests, do not require repetition if performed within 2 weeks. 
c 
Spirometry . 
d 
Pregnancy tests for women of childbearing potential only: urine pregnancy tests at all Extended Treatment 
Period visits. A positive urine pregnancy test must be confirmed by serum HCG. 
e 
See Sections 4.7 and 11.3.1 for follow-up of AEs. 
f 
Refer to Section 4.6.1 for prohibited concomitant medications. 
 
 

FG-3019 
Protocol FGCL-3019-067 Amendment 5.1 
FibroGen, Inc. 
Confidential and Proprietary 
Page 72 of 74 
Appendix 4. HRCT Criteria and Histopathological Criteria for UIP Pattern* 
HRCT Criteria for UIP Pattern 
UIP Pattern (All Four Features)  
• Subpleural, basal predominance 
• Reticular abnormality 
• Honeycombing with or without traction bronchiectasis 
• Absence of features listed (below) as Inconsistent with UIP Pattern 
 
Possible UIP Pattern (All Three Features) 
• Subpleural, basal predominance 
• Reticular abnormality 
• Absence of features listed (below) as Inconsistent with UIP Pattern 
 
Inconsistent with UIP Pattern (Any of the Seven Features) 
• Upper or mid-lung predominance 
• Peribronchovascular predominance 
• Extensive ground glass abnormality (extent > reticular abnormality) 
• Profuse micronodules (bilateral, predominately upper lobes) 
• Discrete cysts (multiple, bilateral away from areas of honeycombing) 
• Diffuse mosaic attenuation/air trapping (bilateral, in three or more lobes) 
• Consolidation in bronchopulmonary segment(s)/lobe(s) 
 
Histopathological Criteria for UIP Pattern 
UIP Pattern (All Four Criteria) 
• Evidence of marked fibrosis/architectural distortion, ± honeycombing in a predominantly 
subpleural/paraseptal distribution 
• Presence of patchy involvement of lung parenchyma by fibrosis 
• Presence of fibroblast foci 
• Absence of features against a diagnosis of UIP suggesting an alternate diagnosis (hyaline 
membranes, organizing pneumonia, granulomas, marked interstitial inflammatory cell 
infiltrate away from honeycombing, predominant airway centered changes, other features 
suggestive of an alternate diagnosis) 
 
*Raghu, 2011 
 
 
 

FG-3019 
Protocol FGCL-3019-067 Amendment 5.1 
FibroGen, Inc. 
Confidential and Proprietary 
Page 73 of 74 
Appendix 5. Radiation Risk Assessment 
The estimated radiation dose that results from participation in this study is based on an estimate 
is for a “standard patient” such as the MIRD phantom used in the ImPACT dose calculator 
spreadsheet. However, the ImPACT spreadsheet does not have a model for all CT platforms and 
for these the DLP*k method is used. For this method we assume a “standard sized” patient 
model, scan length is 25 cm (the length of the lungs for the MIRD Phantom) and a k factor of 
0.014 mSv/mGy*cm for a thoracic scan (AAPM report 96 and European Guidelines 2000). For 
this study the expected doses are summarized in the table below. 
Please NOTE that for each visit, one CT exam will be performed. That exam will consist of a 
required TLC scan. RV scans are not required for the quantitative image analysis data being 
collected for this study. Effective dose estimates provided: (For this study, visits occur at 
Baseline, 6 months, 1 year, 18 months and 2 years (i.e. 5 studies).  
 
Summary 
  
TLC scan - CTDIvol 
6.1 mGy 
TLC scan – DLP (25 cm scan) 
153 mGy*cm 
TLC scan only - DLP 
153 mGy*cm 
Effective Dose per CT exam (TLC only) 
2.14 mSv per exam 
Effective Dose per year (TLC only) (assume 2 studies each 
calendar year) 
4.28 mSv per year 
Effective Dose over entire study (TLC only) (5 studies) 
10.7  mSv over entire study 
Average background radiation (excluding medical exposure to population): 
For a comparison, the average annual exposure from background radiation: 
 
Based on National Average: 
United States 
3.0 mSv per year 
Canada 
1.8 mSv per year 
United Kingdom 
2.5 mSv per year 
Australia  
2.0 mSv per year 
Germany  
2.0 mSv  per year  
India  
2-2.5 mSv per year 

FG-3019 
Protocol FGCL-3019-067 Amendment 5.1 
FibroGen, Inc. 
Confidential and Proprietary 
Page 74 of 74 
References:  
ImPACT http://www.impactscan.org/ctdosimetry.htm 
AAPM - American Association of Physicists in Medicine (2008). The measurement, Reporting 
and Management of Radiation Dose in CT. Report No. 96 of AAPM Task Group 23, (2008) 
 
European Commission (2000). European guidelines on quality criteria for computed 
tomography. EUR 16262 EN. Luxembourg, Office for Official Publications of the European 
Communities. 
 
U.S. NRC Fact Sheet on Biological Effects of Radiation