A Randomized, Placebo-Controlled, Double-Blind Six Month Study Followed by an Open-Label Extension Phase to Evaluate the Efficacy, Safety and Tolerability of MN-001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis, IPF
Sponsor: MediciNova

 
 
 
PROTOCOL NO. MN-001-IPF-201 
Amendment 2 
 
 
 
A Randomized, Placebo-Controlled, Double-Blind Six Month Study 
Followed by an Open-Label Extension Phase to Evaluate the 
Efficacy, Safety and Tolerability of MN-001 in Subjects with 
Idiopathic Pulmonary Fibrosis (IPF)  
 
 
IND Number: 
 069920  
Study Phase: 
2a 
Investigational Product: 
MN-001 (tipelukast) 
 
Protocol Amendment 2: 
 
Sponsor: 
 
December 21, 2015 
 
 
MediciNova, Inc. 
4275 Executive Square 
Suite 650 
La Jolla, CA 92037 
 
Sponsor Contact: 
Kazuko Matsuda, MD PhD MPH 
Chief Medical Officer  
(858) 373-1500  
 
Confidentiality Statement: 
 
 
This document is confidential.  It contains proprietary information 
of MediciNova Inc. Any viewing or disclosure of such information 
that is not authorized in writing by the sponsor is strictly 
prohibited.  Such information may be used solely for the purpose of 
reviewing or conducting this study. 

MediciNova Inc. 
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INVESTIGATOR AGREEMENT 
 
PROTOCOL NUMBER:  MN-001-IPF-201 
 
I have read the foregoing protocol and agree to conduct the study as described herein. 
By signing the protocol, the Investigator agrees to keep all information provided by MediciNova 
Inc, in strict confidence and to request the same from his/her staff and the Institutional Review 
Board. Study.  Documents provided by MediciNova Inc. will be stored appropriately to ensure 
their confidentiality.  The Investigator should not disclose such information to others without 
authorization, except to the extent necessary to conduct the study.  
 
 
 
_____________________________________ 
Investigator Name (Print)  
 
______________________________________ 
_______________________ 
Investigator Signature 
Date 
 

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PROTOCOL SIGNATURE PAGE 
 
Study No: MN-001-IPF-201 
 
 
 
MediciNova Approval: 
  
 Signature:       
                          Date: 
Name: 
Kazuko Matsuda, MD PhD MPH 
 
December 21, 2015 
 
 

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1. 
SYNOPSIS 
Name of Sponsor: MediciNova Inc. 
Name of Investigational Product: MN-001 
Title of Study: A Randomized, Placebo-Controlled, Double-Blind Six Month Study Followed by 
an Open-Label Extension Phase to Evaluate the Efficacy, Safety, and Tolerability of MN-001 in 
Subjects with Idiopathic Pulmonary Fibrosis 
Study Center(s):  Single center  
Phase of Development: 2a 
Study Objectives 
Primary Objectives:  
The primary objectives are to evaluate: 
• 
the effect of MN-001 in subjects with idiopathic pulmonary fibrosis (IPF) on the 
absolute and relative change from baseline of FVC and FVC % predicted up to 26 weeks 
• 
the effect of MN-001 in subjects with idiopathic pulmonary fibrosis (IPF) on 
 the semiannual rate of decline of disease activity based on forced vital capacity (FVC)  
 
Secondary Objectives:  
The secondary objectives are to evaluate: 
• 
the safety and tolerability of MN-001 in subjects with IPF 
• 
Semiannual rate of decline on disease activity based on the 6-minute walk test (6MWT)  
• 
Change from baseline on disease activity based on Modified Medical Research Council 
Dyspnea Score (MMRC)  
• 
Change from baseline on quality of life (QOL)  measured by A Tool to Assess Quality of Life in 
Idiopathic Pulmonary Fibrosis (ATAQ-IPF)  
• 
Frequency of  worsening IPF 
• 
Time to first worsening IPF 
METHODOLOGY 
This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6 month open-
label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in IPF patients. MN-
001 1500 mg to be administered as 750 mg bid or 500 mg tid, or matching placebo will be orally 
administered over a 26-week period in subjects with a confirmed diagnosis of IPF per the American 
Thoracic Society (ATS) 2011 Guidelines (Raghu et al 2011).  Approximately 15 subjects are planned to 
be enrolled. This study will consist of two treatment arms, MN-001 and matching placebo. 
Randomization will occur in a 2:1 ratio (MN-001: placebo).  Eligible subjects will consist of males and 
females ranging in age from 21 to 80 years old, inclusive.  
 
The study will consist of a Screening Phase (up to 3 months prior to Day1) followed by a 26 week 
double-blind Treatment Phase,  a 26 week Open-Label Extension (OLE) phase and a Follow-up Visit 
(within 4 weeks after the last dose).   

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Screening Phase (up to 3 months prior to Day 1)  
During the Screening Phase, subjects will be assessed for study eligibility. The following assessments 
will be performed: medical history including review of prior medications, physical examination 
including height and body weight, vital signs and an electrocardiogram.  Clinical labs, chemistry 
(including liver enzymes and fasting lipid profile), hematology, urinalysis and a serum pregnancy test 
will be collected as well as serum lysyl oxidase-like 2 levels (LOXL2), a biomarker for IPF.   
 
Double-blind Treatment  Phase (26 weeks) 
Subjects who complete all of the screening assessments and meet all inclusion/exclusion criteria will be 
started on MN-001 1500 mg to be administered as 750 mg bid or 500 mg tid, or matching placebo. 
Subjects will return to the clinic on Treatment Day 1 to receive their first dose of study medication. 
Subsequently, subjects will return to the clinic on a regular basis (see Table 1 Schedule of Assessments) 
for 26 weeks.  Subjects participating in the study will return to the clinic Month 1 and every 3 months 
for evaluation. During the Treatment Phase, safety and efficacy parameters will be assessed and 
concomitant medications will be documented.  The safety and tolerability of MN-001 will be evaluated 
by an Independent Safety Monitor during this phase. 
 
Open-Label Extension (OLE) Phase (26 weeks)  
Upon completion of the Double-blind Treatment Phase, subjects who were taking placebo, will 
participate in the open-label extension (OLE) phase for an additional 6 months. Subjects who were in 
the placebo group will be administered MN-001 750 mg bid or 500 mg tid for the remainder of the OLE 
Phase. 
Subjects randomized to the MN-001 group will continue the study drug for additional 6 months. 
All subjects will return to the clinic for evaluation at 1 month and every 3 months after the start of the 
open-label extension phase (Months 7, 9 and 12).  
 
Individual Stopping Criteria 
Subjects who experience an adverse event of Grade 2 nausea and/or diarrhea for greater than 3 
consecutive days or Grade 3 nausea and/or vomiting for greater than 1 day thought to be related to study 
drug will be discontinued from the study.  Additionally, subjects who experience an adverse event of 
Grade 3 abdominal pain lasting for greater than 1 day thought to be related to study drug will be 
discontinued from the study.   
 
Study Stopping Rules 
The study will be stopped if two subjects experience a Grade 4 adverse event thought to be related to 
study drug.   
 
Follow-up Phase  
All subjects who complete the study will return for a follow-up visit (within 4 weeks from last dose) to 
assess adverse event status and to document concomitant medications. 
Number of Subjects (Planned): The number of subjects planned for this study is approximately 15.  
Study Entry Criteria:  
Inclusion Criteria: 

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• 
Male or female subjects ages 21 to 80, inclusive 
• 
Presence of IPF confirmed per ATS criteria (2011)  
• 
Presence of disease, stage I-III defined by GAP index (Gender, Age and Physiology)  
• 
Subjects who are currently treated with OFEV™ (Nintedanib) should be on a stable dose for at 
least 3 months prior to initiation of the study drug.  
• 
Females of child-bearing potential must have a negative serum ß-hCG at screening and must be 
willing to use appropriate contraception (as defined by the investigator) for the duration of study 
treatment and 30 days after the last dose of study treatment. 
• 
Males should practice contraception for the duration of study treatment and 30 days after the last 
dose of study treatment as follows:  condom use and contraception by female partner. 
• 
Subject is in stable condition on the basis of medical history, physical examination, and 
laboratory screening, as determined by the investigator. 
• 
Subject is willing and able to comply with the protocol assessments and visits, in the opinion of 
the study nurse/coordinator and the Investigator. 
• 
Written informed consent is obtained prior to participating the study. 
 
Exclusion Criteria: 
• 
Expected to receive a lung transplant within 1 year from the start of the Treatment Phase or on a 
lung transplant waiting list at the start of the Treatment Phase. 
• 
Known explanation for interstitial lung disease 
• 
Subjects on OFEV™ (Nintedanib) with a dose interruption due to significant adverse events 
within 6 weeks of screening visits. 
• 
Ongoing IPF treatments with investigational therapy 
• 
Ongoing IPF treatments with Esbriet® (Pirfenidone)  
• 
Immunosuppressants (i.e., Mycophenolate, Imuran, Cyclophosphamide), and cytokine 
modulating agents within 1 month of Screening Visit and throughout the study 
• 
Use of antibiotics and systemic steroids due to IPF exacerbation within 1 month of Screening 
Visit 
• 
Clinically significant cardiovascular disease, including myocardial infarct within last 6 months, 
unstable ischemic heart disease, congestive heart failure or angina 
• 
Resting pulse < 50 bpm, SA or AV block, uncontrolled hypertension, or QTcF  > 450 ms 
• 
Immune system disease  
• 
Any significant laboratory abnormality which, in the opinion of the Investigator, may put the 
subject at risk 
• 
History of malignancy < 5 years prior to signing the informed consent, except for adequately 
treated basal cell or squamous cell skin cancer or in situ cervical cancer. 
• 
History or evidence of drug or alcohol abuse 
• 
History of HIV (human immunodeficiency virus) or other active infection. 
• 
Currently has a clinically significant medical condition including the following: neurological, 
psychiatric, immunological, metabolic, hepatic, hematological, pulmonary (other than IPF) , 
cardiovascular (including uncontrolled hypertension), gastrointestinal, urological disorder, or 
central nervous system (CNS) infection that would pose a risk to the subject if they were to 
participate in the study or that might confound the results of the study.   
Note: Active medical conditions that are minor or well-controlled are not exclusionary if, in the 
judgment of the Investigator, they do not affect risk to the subject or the study results. In cases in 
which the impact of the condition upon risk to the subject or study results is unclear, the Medical 

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Monitor should be consulted. 
• 
CYP2C8 and CYP2C9 substrates with narrow therapeutic indices (i.e. paclitaxel, phenytoin and 
S-warfarin) within 14 days of Screening Visit and throughout the study. 
• 
Macrolide or quinolone class antibiotics within 14 days of Screening Visit and throughout the 
study.  
• 
Poor peripheral venous access that will limit the ability to draw blood as judged by the 
Investigator.  
• 
Currently participating, or has participated in, a study with an investigational or marketed 
compound or device within 3 months prior to signing the informed consent. 
• 
Unwilling or unable to conduct Spirometry (Vital Capacity) test. 
• 
Unable to cooperate with any study procedures, unlikely to adhere to the study procedures and 
keep appointments, in the opinion of the Investigator, or is planning to relocate during the study. 
Investigational Product, Dosage and Mode of Administration: Three MN-001 tablets (750 mg) or 
matching placebo to be administered orally twice daily or two tablets (500 mg) or matching placebo to 
be administered three times daily for a total daily dose of 1500 mg. 
Duration of Treatment:  approximately 12 months/52 weeks 
Reference Therapy, Dosage, and Mode of Administration: matching-placebo 
Criteria for Evaluation  
Efficacy Endpoints: 
Efficacy will be assessed by the following:  
• 
FVC and FVC% predicted up to 26 weeks 
• 
Semiannual decline on disease activity based on  forced vital capacity (FVC)  
• 
Annual/semiannual decline on disease activity based on the 6-minute walk test (6MWT) 
• 
Modified Medical Research Council Dyspnea Score (MMRC)  
• 
Quality of life (QOL)  measured by A Tool to Assess Quality of Life in Idiopathic Pulmonary 
Fibrosis (ATAQ-IPF)  
• 
Frequency of  worsening IPF 
• 
Time to first worsening IPF 
Safety Endpoints: 
The proportion of subjects with:  
• 
Treatment-emergent adverse events (TEAEs) 
• 
Treatment-emergent serious adverse events (TESAEs)  
• 
Treatment discontinuations due to treatment-emergent adverse events  
Additional Safety Endpoints:  
• 
Laboratory measures (chemistry, hematology, urinalysis), vital signs, and 12 lead- 
electrocardiograms (ECGs). 
Sample Size Justification 
No prior data are available on which to base assumptions for sample size/power considerations.  The 
results of this pilot study will be used to design future studies, and the sample size of approximately 15 
subjects is deemed to be appropriate for this purpose. 

                                                                                                                            
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Table 1: Schedule of Events 
Phase 
Screening 
Double-Blind Treatment 
Open-Label Extension  
Follow
-up 
End of 
Study 
Early 
Terminationc 
Lab 
retestf 
 
Day 
 -90 
to  -8 
 
Day 
 -7 
(±5d) 
Day 
 1 
 
 
Week 
1 
(±3d) 
Month 
1  
(±5d) 
Month 
3 
(±5d) 
Month 
 4 
(±5d) 
 
Month 
6 
(±5d) 
Week 
27   
(±3d) 
Month  
7 
(±5d) 
 
Month  
9 
(±5d) 
Month 
 10 
(±5d) 
Month 
12 
(±5d) 
Month  
13  
(±5d) 
 
 
 
Visit Type 
Clinic 
Clinic 
Clinic 
Tel 
Clinic 
Clinic 
Tel 
Clinic 
Tel 
Clinic 
Clinic 
Tel 
Clinic 
Clinic 
 
 
Study Visit Number  
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
ET 
LRT 
Informed consent 
Xa b 
Xb 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria review 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medication  history 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical  Examination 
 
X 
 
 
X 
X 
 
X 
 
X 
X 
 
X 
X 
X 
 
Body height 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body weight 
 
X 
 
 
X 
X 
 
X 
 
X 
X 
 
X 
X 
X 
 
Vital signs (sitting) 
 
X 
X 
 
X 
X 
 
X 
 
X 
X 
 
X 
X 
X 
 
12-lead ECG 
 
X 
Xg 
 
X 
X 
 
X 
 
X 
X 
 
X 
 
Xd 
 
CBC/CMP, CK, UA 
Fasting lipid panel  
 
X 
 
 
 
X 
 
X 
 
 
X 
 
 
X 
 
X 
 
 
X 
 
 
Xd  
 
X 
Serum pregnancy test 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine pregnancy test 
 
 
X 
 
X 
X 
 
X 
 
X 
X 
 
X 
 
Xd  
 
Pulmonary function 
 
X 
 
 
 
X 
 
X 
 
 
X 
 
X 
 
Xd 
 
6 minute-walk test 
 
Xh 
 
 
 
Xh 
 
Xh 
 
 
X 
 
X 
 
Xd 
 
ATAQ-IPF 
 
X 
 
 
 
X 
 
X 
 
 
X 
 
X 
 
Xd 
 
MMRC 
 
X 
 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
 
Xd 
 
Plasma for  Biomarker  
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
Xd 
 
Adverse event review 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant med 
review 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
Study Drug 
Dispensing 
 
 
X 
 
X 
X 
 
Xe 
 
X 
X 
 
X 
 
 
 
Dispense/Review/ 
Collect Patient Diary 
 
 
X 
 
X 
X 
 
X 
 
X 
X 
 
X 
 
X 
 
Study Drug 
Accountability 
 
 
 
 
X 
X 
 
X 
 
X 
X 
 
X 
 
X 
 
a. A copy of the informed consent form (ICF) will be given to the patient for review. 
b. Signing of the ICF will occur during screening phase (Visit 1 or Visit 2) prior to conducting any study assessments. 
c. Assessments to be done for early termination for any reason. Other assessments/procedures to be done at PI discretion, if necessary.  
d. Assessments do not need to be performed if prior assessments were within one month of this early termination visit. 

                                                                                                                            
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e. Dispense Open-label study medications after all procedures and assessments have been completed.  
f. Lab retest assessments to be done for subjects with clinically significant abnormal lab findings.  
g. 12-lead ECG to be done at Hour 1.5 ( ± 30 minutes)  post dose 
h. The 6 minute walk test should be performed twice during these visits. 

 
                                                                                                  
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2. 
TABLE OF CONTENTS 
 
1. 
SYNOPSIS ................................................................................................................... 4 
2. 
TABLE OF CONTENTS ........................................................................................... 10 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ............................ 14 
4. 
BACKGROUND AND RATIONALE ...................................................................... 17 
4.1. 
Introduction ................................................................................................................ 17 
4.1.1. 
Justification of the Proposed Human Dose ................................................................ 19 
4.2. 
Prior Clinical Experience ........................................................................................... 19 
4.2.1. 
Clinical Study Overview ............................................................................................ 19 
5. 
TRIAL OBJECTIVES AND PURPOSE ................................................................... 24 
5.1. 
Primary Objectives ..................................................................................................... 24 
5.2. 
Secondary Objectives ................................................................................................. 24 
6. 
OVERALL STUDY DESIGN AND PLAN: DESCRIPTION .................................. 25 
6.1. 
Screening Phase (up to 3 months prior to Day 1) ...................................................... 25 
6.1.1. 
Diagnosis at Screening ............................................................................................... 26 
6.2. 
Double-blind Treatment Phase ( 26 weeks) ............................................................... 26 
6.3. 
Open-Label Extension (OLE) Phase ( 26 weeks) ...................................................... 26 
6.4. 
Follow-up Phase ......................................................................................................... 26 
7. 
SELECTION AND WITHDRAWAL OF SUBJECTS ............................................. 27 
7.1. 
Clinical Trial Population ............................................................................................ 27 
7.2. 
Inclusion/Exclusion Criteria....................................................................................... 27 
7.2.1. 
Inclusion Criteria ........................................................................................................ 27 
7.2.2. 
Exclusion Criteria ....................................................................................................... 27 
7.3. 
Subject Withdrawal/Discontinuation Criteria ............................................................ 28 
7.3.1. 
Individual Stopping Criteria ....................................................................................... 29 
7.3.2. 
Study Stopping Rules ................................................................................................. 29 
7.3.3. 
Follow-up Procedures Upon Discontinuation/Withdrawal ........................................ 29 
8. 
TREATMENT OF SUBJECTS ................................................................................. 30 

 
                                                                                                  
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8.1. 
Description of Study Drug ......................................................................................... 30 
8.2. 
Concomitant Medications .......................................................................................... 30 
8.3. 
Prohibited Medications .............................................................................................. 30 
8.4. 
Treatment Compliance ............................................................................................... 30 
8.5. 
Randomization and Blinding...................................................................................... 31 
8.5.1. 
Emergency Unblinding Procedure ............................................................................. 31 
8.6. 
Dosing Guidelines ...................................................................................................... 31 
8.6.1. 
Treatment Phase ......................................................................................................... 31 
8.7. 
Written Informed Consent.......................................................................................... 32 
8.8. 
Assessments ............................................................................................................... 32 
8.8.1. 
Study Assessments by Visit ....................................................................................... 32 
8.8.1.1. 
Screening Phase (Up to 3 months prior to Day 1) ..................................................... 32 
8.8.1.2. 
Double-Blind Treatment Phase (26 weeks) ............................................................... 33 
8.8.1.3  
Open-Label Extension Phase (26 weeks) ................................................................... 34 
8.8.1.4  
Follow-up / Laboratory Re-test Visits/ Early termination visit ................................. 35 
8.8.2. 
Procedures/Assessment Details .................................................................................. 36 
8.8.2.1. 
Informed Consent ....................................................................................................... 36 
8.8.2.2. 
Medical History .......................................................................................................... 36 
8.8.2.3. 
Prior/Concomitant Medication Review...................................................................... 37 
8.8.2.4. 
Physical Examination ................................................................................................. 37 
8.8.2.5. 
Vital Signs, Height, and Weight ................................................................................ 37 
8.8.2.6. 
Electrocardiogram (12-Lead ECG) ............................................................................ 37 
8.8.2.7. 
Pulmonary Function Test ........................................................................................... 37 
8.8.2.8. 
6-Minute Walk Test (6MWT) .................................................................................... 38 
8.8.2.9. 
Modified Medical Research Council Dyspnea Score (MMRC) ................................ 38 
8.8.2.10. 
ATAQ-IPF questionnaire ........................................................................................... 39 
8.8.2.11. 
Worsening IPF ........................................................................................................... 39 
8.8.2.12. 
Adverse Event (AE) Monitoring ................................................................................ 39 
8.8.2.13. 
Laboratory Evaluations .............................................................................................. 39 
9. 
STUDY DRUG MATERIALS AND MANAGEMENT ........................................... 40 
9.1. 
Study Drug ................................................................................................................. 40 

 
                                                                                                  
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9.2. 
Study Drug Packaging and Labeling .......................................................................... 40 
9.3. 
Study Drug Storage .................................................................................................... 40 
9.4. 
Study Drug Administration ........................................................................................ 40 
9.5. 
Study Drug Accountability ........................................................................................ 41 
10. 
EFFICACY ASSESSMENTS .................................................................................... 42 
11. 
SAFETY AND TOLERABILITY ASSESSMENTS ................................................ 43 
12. 
ADVERSE EVENTS ................................................................................................. 44 
12.1. 
Definition of Adverse Events ..................................................................................... 44 
12.2. 
Assessment of Adverse Events .................................................................................. 44 
12.2.1. 
Severity Assessment................................................................................................... 44 
12.2.2. 
Relationship to Study Drug ........................................................................................ 45 
12.3. 
Recording Adverse Events ......................................................................................... 46 
12.4. 
Treatment and Follow-Up of AEs .............................................................................. 46 
12.5. 
Serious Adverse Events (SAEs) ................................................................................. 46 
12.5.1. 
SAE Reporting Requirements .................................................................................... 47 
12.6. 
Guidance for Overdose .............................................................................................. 48 
12.7. 
Reporting and Follow-up of Pregnancies ................................................................... 48 
12.8. 
Preplanned Hospitalizations or Procedures ................................................................ 49 
13. 
STATISTICS.............................................................................................................. 50 
13.1. 
Data Analysis ............................................................................................................. 50 
13.1.1. 
Analysis Populations .................................................................................................. 50 
13.1.2. 
Statistical Analysis Plan ............................................................................................. 50 
13.1.3. 
Sample Size Justification ........................................................................................... 50 
13.1.4. 
Safety Analysis........................................................................................................... 50 
13.2. 
Direct Access To Source Data/Documents ................................................................ 51 
13.3. 
Study Monitoring ....................................................................................................... 51 
13.4. 
Audits and Inspections ............................................................................................... 52 
13.5. 
Institutional Review Board (IRB) .............................................................................. 52 
13.6. 
Study Documentation ................................................................................................. 52 
14. 
QUALITY CONTROL AND QUALITY ASSURANCE ......................................... 53 
15. 
ETHICS ...................................................................................................................... 54 

 
                                                                                                  
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15.1. 
Ethics Review ............................................................................................................. 54 
15.2. 
Ethical Conduct of the Study ..................................................................................... 54 
15.3. 
Written Informed Consent.......................................................................................... 54 
15.4. 
Confidentiality............................................................................................................ 54 
15.4.1. 
Confidentiality of Data ............................................................................................... 54 
16. 
DATA HANDLING AND RECORDKEEPING....................................................... 55 
16.1. 
Review of Records ..................................................................................................... 55 
16.2. 
Retention of Records .................................................................................................. 55 
17. 
ADMINISTRATIVE AND REGULATORY DETAILS .......................................... 56 
17.1. 
Protocol Amendments and Study Termination .......................................................... 56 
17.2. 
Discontinuation of the Study ...................................................................................... 56 
17.3. 
Compliance with Financial Disclosure Requirements ............................................... 56 
18. 
REFERENCES ........................................................................................................... 57 
19. 
APPENDICES............................................................................................................ 58 
 
 
List of Figures and Tables 
 
           Figure 1: Study Design ................................................................................................ 25 
 
 
Table 1: Schedule of Events ............................................................................................................ 8 
Table 2: Abbreviations and Terms ................................................................................................ 14 
Table 3: BID and TID Dose Regimens ......................................................................................... 19 
Table 4: Clinical Studies ............................................................................................................... 22 
Table 5: Modified Medical Research Council Dyspnea Scale ...................................................... 38 
Table 6: Study Drug Information .................................................................................................. 40 
Table 7: Adverse Events Severity Definition ................................................................................ 44 
Table 8: Adverse Events Causality Definition .............................................................................. 45 
 

 
                                                                                                  
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3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
The following abbreviations and specialist terms are used in this study protocol. 
 
Table 2: Abbreviations and Terms 
Abbreviation  
Term 
5-HT 
5-hydroxytryptamine 
5-LO 
5-lipoxygenase 
6MWT 
6 minute-walk test 
AE 
adverse event 
ALP 
alkaline phosphatase 
ALT (SGPT) 
alanine aminotransferase 
AST (SGOT) 
aspartate aminotransferase 
ATAQ-IPF 
A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis 
ATS 
American Thoracic Society  
AV 
atrioventricular 
AUC 
Area under the curve 
β-hCG  
beta-subunit of human chorionic gonadotropin 
bid 
twice daily 
BP 
blood pressure 
BUN 
Blood urea nitrogen 
CFR 
Code of Federal Regulations 
CIRB 
Central Institutional Review Board 
Cmax 
Maximum plasma concentration 
CNS 
central nervous system 
COPD 
Chronic obstructive pulmonary disease 
CRA 
clinical research associate 
CRF 
case report form 
CRO 
contract research organization 
CSF 
cerebrospinal fluid 
CTCAE 
Common terminology criteria for adverse events 

 
                                                                                                  
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Abbreviation  
Term 
CYP 
cytochrome 
DDI 
drug-drug interaction 
DHD 
dihydrodiol 
dL 
deciliter 
DLCO 
Diffusing capacity of the lungs for carbon monoxide 
DM 
Diabetes mellitus 
DSM-IV-TR 
Diagnostic and Statistical Manual of Mental Disorders- Fourth 
Edition-Text Revision 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
ET 
Early Termination 
FDA 
Food and Drug Administration 
FEV1 
Forced Expiratory Volume in 1 second 
FVC 
Forced Vital Capacity  
GAP  
Gender, Age and Physiology 
GCP 
Good Clinical Practice 
GGT 
Gamma-glutamyl transferase 
GI 
gastrointestinal 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
human immunodeficiency virus 
HR 
heart rate 
HV 
Healthy volunteer 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IND 
Investigational New Drug 
IPF 
Idiopathic Pulmonary Fibrosis 
IRB 
Institutional Review Board 
L 
liter 
LT 
Leukotrienes 

 
                                                                                                  
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Abbreviation  
Term 
LOXL2 
lysyl oxidase-like 2 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
milligram 
ms 
milliseconds 
MMRC 
Modified Medical Research Council Dyspnea Score 
NAS 
Non-alcoholic fatty liver disease activity score 
NASH 
Non-alcoholic steatohepatitis 
NSAID 
Non-steroidal anti-inflammatory drug 
PK 
pharmacokinetics 
PI 
Principal Investigator 
qd 
once-daily 
QTcF 
QT interval corrected for heart rate using Fridericia’s formula 
SA 
sinoatrial 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SOPs 
standard operating procedures 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TEAE 
treatment-emergent adverse event 
TESAE 
treatment-emergent serious adverse event 
tid 
three times daily 
TIMP-1 
tissue inhibitor of metalloproteinases-1 
TRAE 
Treatment-related adverse event 
ULN 
Upper limit of normal 
WBC 
White blood cells 
WHO-DD 
World Health Organization Drug Dictionary 
 
 

 
                                                                                                  
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4. 
BACKGROUND AND RATIONALE 
4.1. 
Introduction 
Idiopathic Pulmonary Fibrosis (IPF) is a progressive and generally fatal interstitial lung 
disease with unknown etiology characterized by a unique pattern of scarring, inflammation, 
proliferation of fibroblasts, and deposition of connective-tissue matrix proteins in the lungs. 
This scarring (fibrosis) and inflammation results in dyspnea and poor gas exchange. It is 
irreversible, has an unpredictable and variable clinical course and associated with an 
extremely poor prognosis.  
According to the Coalition for Pulmonary Fibrosis, IPF is a rare disease and affects 
approximately 128,000 cases in the U.S., with about 15,000 new cases diagnosed annually. 
http://www.coalitionforpf.org/epidemiology-and-risk-factors/ 
Approximately two-thirds of subjects with IPF are over the age of 60 at the time of 
presentation, and the incidence increases with age. Only 20% to 30% of IPF patients survive 
for 5 years following diagnosis. 
Recently two new drugs, Esbriet® (Pirfenidone) and OFEV™ (Nintedanib), were approved by 
FDA for treatment of IPF, however, severe IPF patients (i.e., FVC <45% , DLCO < 30%) were not 
included in their clinical trials (King et al 2014; Richeldi et al 2014) and efficacy of these drugs 
for severe stage IPF still remains unknown. 
MN-001 
MN-001 (4-[6-acetyl-3-[3-[(4-acetyl-3-hydroxy-2-propylphenyl)thio] propoxy]-2-
propylphenoxy]butanoic acid), formerly KCA-757 (Kyorin Pharmaceutical Co., Ltd.) is a 
novel, orally bioavailable small molecule compound which demonstrates anti-inflammatory 
and anti-fibrotic activity in preclinical models.  In vitro receptor binding and enzyme 
inhibition assays have identified several mechanisms of MN-001 including leukotriene (LT) 
receptor antagonism and inhibition of phosphodiesterases (PDEs) 3 and 4, 5-lipoxygenase (5-
LO), phospholipase C and thromboxane A2.  These in vitro studies also demonstrate similar 
activity of a metabolite of MN-001 (MN-002). 
The 5-lipoxygenase (5-LO) pathway, which generates leukotrienes (LT) from arachidonic 
acid, is one of the major inflammatory systems in mammals (Samuelsson 1987; Funk 2001). 
Since its discovery, this compound was developed for the treatment of asthma and interstitial 
cystitis. Leukotrienes (LTs) are pro-inflammatory and pro-fibrogenic mediators derived from 
the 5-lipoxygenase (5-LO) pathway of arachidonic acid metabolism. They are thought to play 
a role in a number of disease processes. Patients with this chronic, progressive interstitial 
disorder of the lung parenchyma were found to have 15-fold more LTB4 and 5-fold more 
LTC4 in lung homogenates than normal and their recovered alveolar macrophages produced 
significantly greater amounts of these LTs than cells from normal volunteers. (Wilborn et al 
1996). Models of bleomycin-induced pulmonary fibrosis strongly support a key role of cys-
LTs. Alveolar septal thickening characterized by interstitial infiltration with macrophages and 

 
                                                                                                  
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fibroblasts and the accumulation of collagen fibers were markedly reduced in mice with 
targeted gene disruption of the CysLT2 receptor (Beller et al 2004) 5-LO plays important role 
in pulmonary inflammation and remodeling in the IL-13 induced pulmonary fibrosis in Tg+ 
mice with (+/+) 5-LO loci (Shim et al 2006). 
Rationale for the use of MN-001 in human IPF treatment is based on an animal model study 
of pulmonary fibrosis. MN-001 was evaluated in the Bleomycin-induced pulmonary fibrosis 
mouse model. The pulmonary fibrosis mouse model was developed by single intratracheal 
administration of bleomycin sulphate. The mice were administered either MN-001 once daily 
(30, 100, and 300 mg/kg) or vehicle for 14 days. In the mouse model study, treatment with 
MN-001 significantly reduced the Ashcroft Score (Ashcroft et al 1988) and Lung 
Hydroxyproline content compared with vehicle in a dose dependent manner, demonstrating 
the anti-fibrotic effect of MN-001.   
In other fibrotic disease model studies, MN-001 also significantly reduced fibrosis. MN-001 
tested in Non-alcoholic steatohepatitis (NASH) mouse model also significantly improved % 
area of fibrosis. MN-001 tended to reduce liver hydroxyproline content, supporting its anti-
fibrotic property in liver fibrosis. Treatment with MN-001 significantly reduced NAFLD 
activity score (NAS).  The improvement in NAS was attributable to the reduction in lobular 
inflammation and hepatocyte ballooning. MN-001 significantly down-regulated the gene 
expression of fibrosis related factors, i.e., LOXL2 and TIMP-1. 
 
 

 
                                                                                                  
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4.1.1. 
Justification of the Proposed Human Dose  
 
This is the first trial to evaluate the safety and efficacy of MN-001 in IPF-diagnosed patients. 
The dose of 750 mg bid or 500 mg tid (1500 mg/day) has been proposed for the following 
reasons: 
• In the Phase 2 clinical trial targeting asthma subjects (MN-001-CL-001), treatment 
with the higher dose MN-001 (1500 mg/day)  significantly improved FEV1 from 
baseline (p=0.021 for 500 mg tid, p=0.058 for 750 mg bid) compared to placebo but 
was not effective with the lower dose (750 mg/day).  
• In the Phase 3 clinical trial targeting asthma subjects (MN-001-CL-004), MN-001 
1500 mg/day was well-tolerated and safe for up to 12 weeks. 
• In the Phase 1 PK study (MN-001-CL-003), 2 dose regimens for the same daily dose 
in healthy volunteers was evaluated.  MN-001 1500 mg/day was given as 500 mg tid 
and 750 mg bid. The mean values of average Cmax and AUC(tau) were calculated.  This 
result suggests that MN-001 demonstrates efficient exposure when administrated in 
bid rather than the tid regimen. 
Table 3: BID and TID Dose Regimens 
Dose regimen 
MN-001 
MN-002 (metabolite) 
Cmax ng/mL 
AUC(tau) ng*hr/mL 
Cmax ng/mL 
AUC(tau) ng*hr/mL 
500 mg tid 
1607 
2814.46 
10182 
40051.28 
750 mg bid 
2279 
4437.08 
13900 
67660.44 
 
• In the bleomycin-induced pulmonary fibrosis model study, MN-001 300 mg/kg dose 
group showed significant improvement in the Ashcroft score. Human-equivalent dose 
(HED) daily dose calculated from 300 mg/kg mouse dose is 24 mg/kg (300 x 0.08) 
which is 1440 mg/day for a 60 kg adult.  
4.2. 
Prior Clinical Experience 
4.2.1. 
Clinical Study Overview 
To date, a total of 11 clinical trials have been conducted with MN-001 and over 600 subjects 
have been dosed. Single and multiple doses of MN-001 ranging from 80 mg to 2000 mg for 
up to 12 weeks in 6 Phase 1 trials, 4 Phase 2 trials and 1 Phase 3 trial have been evaluated in 
healthy subjects and patients with asthma and interstitial cystitis. A summary of completed 
trials is provided in Table 5. 
Phase 1 Studies 
In the single dose studies of 80 mg to 600 mg, there appeared to be few adverse events. The 
most common treatment emergent adverse events (TEAEs) were mild diarrhea, sensation of 

 
                                                                                                  
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borborygmus, and heavy headedness. No clinically significant changes in vital signs, ECGs, 
and safety labs were observed.   
In two multi-dose studies (Study KCA-757 and Study 478-02), MN-001 250 mg to 1000 mg 
bid was administered for approximately 7 days in healthy volunteers and subjects with mild 
bronchial hypersensitivity. No serious adverse events were reported and no subjects 
discontinued the study due to an adverse event. The most common AEs experienced in study 
478-02 were upper abdominal pain (reported by 1 subject each in the 500 mg and 750 mg 
groups), loose stools (reported by 1 subject each in the 500 mg and 1000 mg groups), and 
nausea (reported by 1 subject each in the 750 mg and 1000 mg groups). The Investigator 
considered the following treatment-emergent AEs to be possibly or probably related to study 
drug (treatment group in parentheses): abdominal pain (placebo), upper abdominal pain (500 
mg and 750 mg), dyspepsia (1000 mg), fatigue (placebo), loose stools (500 mg and 1000 mg), 
nausea (750 mg and 1000 mg), somnolence (750 mg), urine odor abnormal (500 mg). 
In study 478-02, vital signs were within normal limits.  All mean ECG measurements 
remained within normal limits. At Hour 359.67 mean QTc for the 750 mg group increased 
27.66 ms from baseline for a mean QTc of 395.83 ms and mean heart rate increased 14.50 
bpm from baseline for a mean heart rate of 70.67 bpm. No other marked mean changes from 
baseline were noted. The Investigator considered none of the ECG abnormalities in this study 
to be adverse events. 
All treatment groups, including the placebo group, exhibited notable mean increases in 
CPK (ranging from approximately 22 to 135 U/L) at Hour 360. No other marked mean 
changes from baseline were noted for the remaining serum chemistry parameters. 
High Doses of MN-001 (1500 mg/day) 
Study MN-001-CL-003 was another multiple dose study in healthy volunteers testing doses of 
1500 mg/day for 5 days. In this study, no SAEs occurred and no subjects discontinued the 
study due to a TEAE. Two subjects reported a TEAE during the study. Both subjects 
experienced dizziness (mild, possibly related), one on Day 2 and the other on Day 3 of dosing 
with MN-001 750 mg bid. 
 
Mean serum chemistry and hematology results showed transient fluctuations between 
screening and follow-up on Day 11, 8 hours after the last dose, but no apparent treatment 
related trends were observed for any of the serum chemistry or hematological parameters 
evaluated. None of the abnormal laboratory values observed during the study was considered 
a clinically significant treatment-related change, and no AEs related to abnormal laboratory 
values were reported. No clinically significant changes in vital sign parameters and ECGs 
were noted during the study. 
Phase 2 Studies 

 
                                                                                                  
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Study KCA-757-T201 
MN-001 100 mg, 200 mg, 400 mg and 600 mg was evaluated in 112 asthma patients over 
6weeks. No serious adverse events occurred. Eleven subjects discontinued due to a TEAE. 
Seven subjects experienced 20 adverse reactions. 
Study MN-001-CL-001  
MN-001 (500 mg tid, 750 mg bid and 750 mg qd) or placebo was evaluated for 4 weeks in 
147 asthma patients. AEs within the Gastrointestinal Disorders system organ class were the 
most commonly observed, reported by 18.2% of the combined MN-001 subjects and 10.8% 
of those receiving placebo. These AEs appeared to demonstrate a dose relationship, and the 
most frequent AEs among the combined MN-001 treatment groups were diarrhea, nausea, 
and vomiting. Each of these individual events occurred in less than 10% (with only diarrhea 
exceeding 5%) of all MN-001-treated subjects. No severe gastrointestinal AEs were 
reported, and none led to discontinuation from the study. 
Study MN-001-CL-002 
MN-001 500 mg bid and 500 mg qd were evaluated in 305 patient with interstitial cystitis. 
The TEAE most frequently reported by all the patients in the MN-001 group was diarrhea, 
which was higher in both MN-001 groups compared with placebo and higher in the MN-001 
500 mg bid group compared with the MN-001 500 mg qd group. Although the incidence of 
loose stools was lower than the incidence of diarrhea, similar comparisons as seen with 
diarrhea among the treatment groups were observed for loose stools. 
Phase 3 Study 
MN-001 (500 mg tid or 750 mg bid) or placebo was evaluated for 12 weeks in patients with 
asthma.  In the all MN-001 group, the system organ class (SOC) categories with the most 
reported TEAEs were gastrointestinal disorders (20, 19% vs. 2, 5% in the placebo group), 
infections and Infestations (12, 11% vs. 8, 18% in the placebo group) and respiratory, thoracic 
and mediastinal disorders (9, 8% vs. 3, 7% in the placebo group). In the placebo group, the 
SOC category with the most reported TEAEs (incidence of ≥ 10%) was infections and 
infestations (8, 18%). The only AE that was reported in > 2 subjects in each treatment group 
was diarrhea, which occurred at a higher frequency in the 750 mg bid group than the 500 mg 
tid group (11, 21% vs. 5, 9% respectively). The TEAEs experienced by > 2 subjects in the all 
MN-001 group were nasopharyngitis (4, 4%), urinary tract infection (3, 3%), asthma (3, 3%), 
and joint sprain (3, 3%). 
 
Additional safety information is reported in the Investigator Brochure. 
 
 

 
                                                                                                  
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Table 4: Clinical Studies 
Phase 
Study 
Number  
Title 
Design 
Dosage 
Treatment 
Duration 
Target 
Population 
# of Subjects 
Enrolled 
1 
2254 
Ascending dose tolerance 
study of KCA-757 (MN-
001) in healthy volunteers 
with preliminary 
pharmacokinetic assessment 
Open-label, single-
dose 
80 mg, 
160 mg 
single-dose 
Healthy 
Volunteers 
5 
1 
151408 
The disposition of 14C-
KCA-757 (MN-001) in man 
Open-label, single 
oral dose to 
investigate the 
rates and routes of 
excretion and the 
plasma kinetics of 
total radioactivity 
following [14C]-
KCA-757 (MN-
001) 
80 mg 
single-dose 
Healthy 
Volunteers 
4 
1 
Kyorin 
Phase 1 Trial of KCA-757 
(MN-001) Single-dose 
study 
Ascending, single-
dose to evaluate 
safety and PK 
100 mg 
to 600 
mg 
single-dose 
Healthy 
Volunteers 
29 
1 
Kyorin 
Phase 1 Trial of KCA-757 
(MN-001) Repeated-dose 
study 
Safety and PK 
300 mg 
bid 
7 days 
Healthy 
Volunteers 
6 
1 
478-02 
A Randomized, Double-
Blind, Placebo-Controlled, 
Ascending Dose Study to 
Assess the Safety and 
Tolerability of MN-001 
When Given in Multiple 
Doses to Healthy 
Volunteers and the 
Pharmacodynamic Effect of 
MN-001 When Given in 
Multiple Doses to 
Volunteers with Mild 
Bronchial Hypersensitivity 
Randomized, 
double-blind safety 
and tolerability 
250, 
500, 
750, 
1000 mg 
bid 
6 days 
Healthy 
Volunteers 
and 
bronchial 
hypersensiti
ve subjects 
32 
1 
MN-
001-CL-
003 
A Phase I, Randomized 
Single-blind study to 
Determine the Relative 
Pharmacokinetics of Two 
Dosing Regimens of MN-
001 Administered Orally to 
Normal, Healthy Male and 
Female Subjects 
Single-Blind, 
Randomized 1:1, 
Crossover 
500mg 
tid and 
750mg 
bid 
5 days of 
dosing for 
each regimen 
Healthy 
Volunteers 
11 subjects 
randomized and 
completed 
2 
KCA-
757-
T201 
Early Phase 2 Study of 
KCA-757 (MN-001) 
 Open-label 
50 mg 
bid, 100 
mg bid, 
200 mg 
bid, 300 
mg bid 
6 weeks 
Bronchial 
asthma 
 108 subjects  
2 
4204 
A standard antigen 
challenge study of KCA-
757 (MN-001) in 10 
patients with asthma 
 Cross-over 
300 mg 
bid 
single-dose 
Asthma 
3  

 
                                                                                                  
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Phase 
Study 
Number  
Title 
Design 
Dosage 
Treatment 
Duration 
Target 
Population 
# of Subjects 
Enrolled 
2 
MN-
001-CL-
001 
A Randomized, Double-
Blind, Placebo-Controlled 
Study Evaluating the Effects 
of MN-001 in Subjects with 
Mild to Moderate Asthma 
Double-Blind, 
Randomized  
500mg 
tid, 
750mg 
bid, 
750mg 
qd, or 
placebo 
4 weeks  
Mild to 
Moderate 
Asthma pts 
147 subjects 
randomized 
with 131 
completing, 
placebo N=37, 
500mg tid 
N=37, 750mg 
bid N=37, 
750mg qd 
N=36 
2 
MN-
001-CL-
002 
A Phase II, Randomized, 
Double-blind, Placebo-
Controlled Multi-Center 
Study to Evaluate the 
Efficacy and Safety of Two 
Dosing Regimens of MN-
001 in Patients with 
Interstitial Cystitis 
Double-Blind, 
Randomized 1:1:1 
500mg 
bid,          
500mg 
qd, or 
placebo 
8 weeks  
Interstitial 
Cystitis pts 
305 subjects 
randomized 
with 251 
completing, 
placebo N=102, 
500mg qd=95, 
500mg bid 
N=108 
3 
MN-
001-CL-
004 
A Randomized, Double-
Blind, Placebo-Controlled 
Study Evaluating the Effects 
of MN-001 in Subjects with 
Mild to Moderate Asthma 
Double-Blind, 
Randomized 1:1:1 
500mg 
tid,         
750mg 
bid, or 
placebo 
12 weeks  
Mild to 
Moderate 
Asthma pts 
152 subjects 
randomized,         
108 MN-001,       
44 Placebo 
 
 
 

 
 
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5. 
TRIAL OBJECTIVES AND PURPOSE 
This is a randomized, placebo-controlled, double-blind 6-month study followed by a 6-month 
open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in 
subjects with IPF. 
5.1. 
Primary Objectives 
 
The primary objectives of the study is to evaluate: 
 
• The effect of MN-001 in subjects with idiopathic pulmonary fibrosis (IPF) on the 
absolute and relative change from baseline of FVC and FVC % predicted up to 26 weeks 
• The effect of MN-001 in subjects with idiopathic pulmonary fibrosis (IPF) on the 
semiannual rate of decline of disease activity based on forced vital capacity (FVC)  
5.2. 
Secondary Objectives 
The secondary objectives are to evaluate: 
• The safety and tolerability of MN-001 in subjects with IPF 
• Semiannual decline on disease activity based on the 6-minute walk test (6MWT) 
• Change from baseline on disease activity based on Modified Medical Research Council 
Dyspnea Score (MMRC)  
• Change from baseline on quality of life (QOL)  measured by A Tool to Assess Quality of 
Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF)  
• Frequency of  worsening IPF 
• Time to first worsening IPF 

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6. 
OVERALL STUDY DESIGN AND PLAN: DESCRIPTION 
This is a randomized, placebo-controlled, double-blind 6-month study followed by a 6-month 
open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in IPF 
patients. MN-001  1500 mg to be administered as 750 mg bid or 500 mg tid, or matching placebo will 
be orally administered twice daily over a 26-week period in subjects with a confirmed diagnosis 
of IPF per the ATS 2011 Guidelines (Raghu et al 2011).  Approximately 15 subjects are planned 
to be enrolled. This study will consist of two treatment arms, MN-001 and matching placebo. 
Randomization will occur in a 2:1 ratio (MN-001: placebo).  Eligible subjects will consist of 
males and females ranging in age from 21 to 80 years old, inclusive.  
The study will consist of a Screening Phase (up to 3 months prior to Day 1) followed by a 26- 
week double-blind Treatment Phase, a 26 week Open-Label Extension (OLE) phase and a 
Follow-up Visit (within 4 weeks after the last dose).   
The study phases are described below and displayed in Figure 1 and the Schedule of 
Assessments is displayed in Table 1. 
           
           Figure 1: 
Study Design 
 
 
 
                         R 
 
 
 
6.1. 
Screening Phase (up to 3 months prior to Day 1) 
 
During the Screening Phase (up to 3 months prior to Day 1), subjects will be approached for 
study participation and an informed consent form will be given to the patient. If interested in 
participating in the study on Day -7, subjects will return to the office, and if there are no 
additional questions, subjects will sign the informed consent form. After signing the informed 
consent form, the following assessments will be performed: medical history including review of 
prior medications, physical examination including height and body weight, vital signs and 12- 
lead electrocardiogram.  Clinical labs, chemistry (including CPK, liver enzymes and fasting lipid 
profile), hematology, urinalysis and a serum pregnancy test (if applicable) will be collected.  
Pulmonary function, SpO2, 6 minute-walk test (6MWT), Dyspnea score (MMRC) and ATAQ-
IPF questionnaire will be conducted. 
Up to -3 M              Day 1                 26 Weeks                                                26 weeks                                         4 weeks after last dose       
Screening                          Double-blind Phase                    OLE Phase                                  Follow-up 
 
Screening 
MN-001 
Placebo 
MN-001 
Follow-
up  

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Detailed information on permitted and excluded concomitant medications is provided in Section 
8.2 and Section 8.3 of the protocol.  
6.1.1. 
Diagnosis at Screening 
Subjects must have a confirmed diagnosis of IPF by ATS criteria (2011) and presence of disease, 
stage I-III defined by GAP index (Gender, Age and Physiology).  
The diagnosis must be noted in the source documents and a copy of the report must be obtained. 
6.2. 
Double-blind Treatment Phase ( 26 weeks)  
 
Subjects who complete all of the screening assessments and continue to be eligible will be 
enrolled. Subjects will return to the clinic on Treatment Day 1 to receive their first dose of study 
medication. Thereafter, subjects will return to the clinic at Month 1, 3, and Month 6 and will be 
followed by telephone at Week 1 and Month 4. During these visits, subjects will undergo safety 
and efficacy assessments.  See Table 1 for visit schedule and procedures. Throughout the 
Treatment Phase, safety and efficacy parameters will be assessed and concomitant medications 
will also be documented.   
 
6.3. 
Open-Label Extension (OLE) Phase ( 26 weeks)  
Upon completion of the Double-blind Treatment Phase, subjects who were taking placebo, will 
participate in the open-label extension (OLE) phase for 6 months. Subjects who were in the 
placebo group will be administered MN-001 1500 mg to be administered as 750 mg bid or 500 mg tid 
for the remainder of the OLE Phase. Subjects randomized to the MN-001 group will continue the 
study drug (MN-001) for an additional 6 months. 
All subjects will return to the clinic 1 month and every 3 months after the start of the open label 
phase (Months 7, 9 and 12).  Follow-up telephone visits will occur at 1 week and 4 months after 
the start of the open label phase (Week 27 and Month 10). 
See Table 1 for visit schedule and procedures. Throughout the Open-Label Extension Phase, 
safety and efficacy parameters will be assessed and concomitant medications will also be 
documented.   
An independent safety monitor will review the data on a regular basis during the Double-blind 
Treatment Phase and OLE Phase. 
 
6.4. 
Follow-up Phase 
All subjects who complete the study will return for their final visit at 4 weeks after their last dose 
for safety assessments and to assess adverse event status and document concomitant medications. 

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7. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
7.1. 
Clinical Trial Population 
The population for this trial will include male and female subjects ≥ 21 and ≤ 80 years of age 
with a confirmed diagnosis of IPF. 
7.2. 
Inclusion/Exclusion Criteria 
7.2.1. 
Inclusion Criteria 
 
• Male or female subjects ages 21 to 80, inclusive 
• Presence of IPF confirmed per ATS criteria (2011)  
• Presence of stage I-III defined by GAP index (Gender, Age and Physiology)  
• Subjects who are currently treated with OFEV™ (Nintedanib), should be on a stable dose 
for at least 3 months prior to initiation of the study drug.  
• Females of child-bearing potential must have a negative serum ß-hCG at screening and 
must be willing to use appropriate contraception (as defined by the investigator) for the 
duration of study treatment and 30 days after the last dose of study treatment. 
• Males should practice contraception for the duration of study treatment and 30 days after 
the last dose of study treatment as follows:  condom use and contraception by female 
partner. 
• Subject is in stable condition on the basis of medical history, physical examination, and 
laboratory screening, as determined by the investigator. 
• Subject is willing and able to comply with the protocol assessments and visits, in the 
opinion of the study nurse/coordinator and the Investigator. 
• Written informed consent is obtained prior to participating in the study. 
 
7.2.2. 
Exclusion Criteria 
 
• Expected to receive a lung transplant within 1 year from the start of the Treatment Phase 
or on a lung transplant waiting list at the start of the Treatment Phase. 
• Known explanation for interstitial lung disease 
• Subjects on OFEV™ (Nintedanib) with dose interruption due to significant adverse 
events within 6 weeks of screening visits. 
• Ongoing IPF treatments with investigational therapy  
• Ongoing IPF treatment with Esbriet® (Pirfenidone)  
• Immunosuppressants (i.e., Mycophenolate, Imuran, Cyclophosphamide), and cytokine 
modulating agents within 1 month of Screening Visit and throughout the study 
• Use of antibiotics and systemic steroids due to IPF exacerbation within 1 month of 
Screening Visit 
• Clinically significant cardiovascular disease, including myocardial infarct within last 6 

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months, unstable ischemic heart disease, congestive heart failure or angina 
• Resting pulse < 50 bpm, SA or AV block, uncontrolled hypertension, or QTcF > 450 ms 
• Immune system disease  
• Any significant laboratory abnormality which, in the opinion of the Investigator, may put 
the subject at risk 
• History of malignancy < 5 years prior to signing the informed consent, except for 
adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. 
• History or evidence of drug or alcohol abuse 
• History of HIV (human immunodeficiency virus) or other active infection. 
• Currently has a clinically significant medical condition including the following: 
neurological, psychiatric, metabolic, hepatic, hematological, pulmonary (other than IPF), 
cardiovascular (including uncontrolled hypertension), gastrointestinal, urological 
disorder, or central nervous system (CNS) infection that would pose a risk to the subject 
if they were to participate in the study or that might confound the results of the study.  
  
Note: Active medical conditions that are minor or well-controlled are not 
exclusionary if, in the judgment of the Investigator, they do not affect risk to the 
subject or the study results. In cases in which the impact of the condition upon risk to 
the subject or study results is unclear, the Medical  Monitor should be consulted. 
 
• CYP2C8 and CYP2C9 substrates with narrow therapeutic indices (i.e., paclitaxel, 
phenytoin and S-warfarin) within 14 days of Screening Visit and throughout the study. 
• Macrolide or quinolone class antibiotics within 14 days of Screening Visit and 
throughout the study.  
• Poor peripheral venous access that will limit the ability to draw blood as judged by the 
Investigator.  
• Currently participating, or has participated in, a study with an investigational or marketed 
compound or device within 3 months prior to signing the informed consent. 
• Unwilling or unable to conduct Vital Capacity test. 
• Unable to cooperate with any study procedures, unlikely to adhere to the study 
procedures and keep appointments, in the opinion of the Investigator, or is planning to 
relocate during the study. 
 
7.3. 
Subject Withdrawal/Discontinuation Criteria 
Subjects may request to be withdrawn from the study at any time for any reason.  
The Investigator may interrupt the treatment of any subject whose health or well-being may be 
compromised by continuation in the study.  The following instances require subjects to be 
withdrawn from the study: 
 Subject fails to adequately comply with the dosing, evaluations, or other requirements of 
the study at the discretion of Investigator.  
 Subjects who have adverse events that require discontinuation of study medication; 

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 Subjects who, in the opinion of the Investigator, should be discontinued for their well-
being;  
• Subjects who start Esbriet® (Pirfenidone) or OFEV™ (Nintedanib) during the study. 
 Subjects who are no longer able to understand task instructions or to perform tests 
adequately. 
 Subject becomes pregnant during the study. See section 12.7 for reporting requirements 
and follow-up of the pregnancy. 
If a subject withdraws or is removed from the study for any reason, the reason and date of 
discontinuation of study medication should be recorded in the appropriate section of the Case 
Report Form (CRF).  At the time of study discontinuation, every effort should be made to ensure 
all Early Termination (ET) procedures and evaluations are performed.  
The study sponsor reserve the right to discontinue the study at any time for medical or 
administrative reasons.   
7.3.1. 
Individual Stopping Criteria 
Subjects who experience an adverse event of Grade 2 nausea and/or diarrhea for greater than 3 
consecutive days, or Grade 3 nausea and/or vomiting for greater than 1 day thought to be related 
to study drug will be discontinued from the study.  Additionally, subjects who experience an 
adverse event of Grade 3 abdominal pain lasting for greater than 1 day thought to be related to 
study drug will be discontinued from the study.   
7.3.2. 
Study Stopping Rules 
The study will be stopped if two subjects experience any Grade 4 (i.e., life-threatening 
consequences; urgent intervention indicated) adverse event thought to be related to study drug.  
The medical monitor will review the cases with the PI prior to the decision to terminate the study 
is made. 
7.3.3. 
Follow-up Procedures Upon Discontinuation/Withdrawal 
A termination CRF page should be completed for every subject who received study medication 
whether or not the subject completed the study. The reason for discontinuation should be 
indicated on the CRF. Any AEs that are present at the time of discontinuation/ withdrawal 
should be followed in accordance with the safety requirements outlined in Section 12. 

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8. 
TREATMENT OF SUBJECTS 
8.1. 
Description of Study Drug 
MN-001 250 mg tablets will be provided in bottles and will be stored at room temperature. 
8.2. 
Concomitant Medications 
Concomitant medications required for the treatment of symptoms and signs of idiopathic 
pulmonary fibrosis are permitted except as excluded below.  
 
Patients who are treated with OFEV™ (Nintedanib) should be on a stable dose for at least 3 
months prior to study drug treatment. 
 
Concomitant medications for treatment of adverse events may be allowed. Subjects will be 
instructed to contact a member of the study staff prior to taking any medication. 
8.3. 
Prohibited Medications 
The following medications are prohibited prior to and during study participation: 
• Ongoing IPF treatments with investigational therapy 
• Ongoing IPF treatment with Esbriet® (Pirfenidone) 
• Immunosuppressants (i.e., Mycophenolate, Imuran, Cyclophosphamide), and cytokine 
modulating agents within 1 month of Screening Visit and throughout the study 
• CYP2C8 andCYP2C9 substrates with narrow therapeutic indices (i.e. paclitaxel, 
phenytoin and S-warfarin) within 14 days of Screening Visit and throughout the study. 
• Macrolides and other antibiotics within 14 days of Screening Visit and throughout the 
study unless administered for a short-term treatment course during the study. 
• Antibiotics and systemic steroids due to IPF exacerbation within 1 month of screening 
visit.  
The medical monitor should be consulted prior to administration of a prohibited concomitant 
medication. 
8.4. 
Treatment Compliance 
Compliance will be monitored closely at each visit. Subjects will be instructed to bring all 
unused study medication with them to each visit. Compliance will be assessed by counting 
capsules and dividing the actual number of doses taken (per capsule count) by the number of 
doses the subject should have taken within a visit period and multiplying by 100. All subjects 
will be reminded of the importance of strict compliance with taking study medication for the 
effectiveness of treatment and for the successful outcome of the study. Subjects who miss more 
than 25% of scheduled doses or take more than 125% of the scheduled doses will be considered 
noncompliant and may be discontinued from the study per investigator’s judgment.    

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8.5. 
Randomization and Blinding 
During the Double-Blind Treatment Phase, randomization will occur in a 2:1 ratio (MN-001: 
placebo). The randomization scheme will be generated by the research software application, 
StudyTRAX. Subjects and all personnel involved with the conduct and interpretation of the 
study, including the investigators, site personnel, and sponsor staff will be blinded to the 
treatment codes. Randomization data will be kept strictly confidential, filed securely by an 
appropriate group with the sponsor and accessible only to authorized persons (e.g., unblinded  
independent safety monitor) until the database is locked.  
To ensure that treatment allocation remains concealed to both staff and participants, the 
following measures will be taken:  
•  Active drug and placebo will be identical in appearance  
•  Drug supplies to investigational pharmacy will be coded  
  
8.5.1. 
Emergency Unblinding Procedure  
A master list of all treatments and the subject numbers associated with them will be maintained 
in a sealed envelope by the sponsor.  In the event that emergency conditions require knowledge 
of the study treatment given, the blind may be broken. If possible, before breaking the blind, the 
investigator should consult with the sponsor to ascertain the necessity of breaking the code. 
Unblinding may take place in situations where the safe management of the patient’s medical 
condition necessitates knowledge of the study medication by the person(s) responsible for the 
patient’s care. Where possible, members of the local research team should remain unblinded.  
If unblinding is required, the local PI/other medical staff should contact the sponsor at 858-373-
1500- via telephone or safetymonitors@medicinova.com via email.  
The person requesting the unblinding will provide details including the protocol number and trial 
name, name of the requester, reason for unblinding, patient name, participant number and 
timeline to receive the un-blinded information. If knowledge of the treatment allocation is 
required in order to treat the patient, the code break number will be given to the local PI/other 
medical staff requesting to unblind the patient. In this way, the treatment will be un-blinded at 
the local site but not to sponsor.  
The local PI/medical staff will deal with the medical emergency (upon receipt of the treatment 
allocation revealed by the code break number). Details of the code break will be documented on 
the code break form and filed at the local site.  
Code breaks will also be documented at the end of the study in the statistical report. 
8.6. 
Dosing Guidelines 
8.6.1. 
Treatment Phase 
On Day 1, once baseline assessments are completed, subjects will be administered their first dose 
of study drug (MN-001 or matching placebo) in the clinic.  Subjects will continue to take study 
drug twice or 3 times daily for 26 weeks during the Double-blind phase. Upon completion of the 

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Double-blind Treatment Phase, subjects who were taking placebo will participate in the open-
label extension (OLE) phase for 26 weeks. Subjects who were taking MN-001 will continue to 
take MN-001 for 26 weeks. 
8.7. 
Written Informed Consent 
Each subject is required to provide written informed consent prior to undergoing any study 
procedures. A copy of the signed and dated informed consent form (in a language in which the 
subject is fluent) is required to be given to the subject. If a subject withdraws consent, data 
collected up to the time of discontinuation will be used to evaluate study results.  
8.8. 
Assessments  
The Schedule of Assessments is presented in Table 1.  
Clinical laboratory evaluations will be performed. All clinical and laboratory evaluations, 
procedures related to inclusion/exclusion criteria, or performed during treatment must be 
reviewed, initialed and dated by the Principal Investigator or appropriate designee listed on Form 
FDA 1572.  
8.8.1. 
Study Assessments by Visit 
The following is a summary of assessments by study visit. 
8.8.1.1. 
Screening Phase (Up to 3 months prior to Day 1)  
Visit 1 (Day -90 to Day – 8)  
At any point during this time, subject may be approached for participation in the study. An 
informed consent form (ICF) will be given to the subject and the subject will be instructed to 
read the ICF and ask the study staff any questions they may have.  The subject can either sign the 
ICF then or defer signing until they return for Study Visit 2. 
Visit 2 (Day- 7 ± 5 days)  
During the Screening Phase, once the informed consent form is signed, the following 
assessments will be performed/collected): 
• Inclusion/Exclusion criteria review 
• Medical history 
• Physical examination 
• Height/body weight 
• Vital signs including supine blood pressure, respiratory rate, heart rate, and temperature 
• 12 lead Electrocardiogram (ECG)  
• Fasting safety labs - chemistry (including CPK, liver enzymes, lipid panel) hematology, 
and urinalysis labs 

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• Serum β-hCG (pre-menopausal females) 
• Blood Sample for biomarker  
• Prior/concomitant medication review  
• Pulmonary function test   
• 6 minute-walk test (6MWT)* 
• Dyspnea score (MMRC: Modified Medical Research Council Dyspnea Score)  
• ATAQ-IPF ( A Tool to Assess Quality of Life in IPF)  
The results of pulmonary function test, 6MWT, MMRC and ATAQ-IPF at this visit are 
considered “Baseline” values. 
* Two tests should be performed for 6MWT 
8.8.1.2. 
Double-Blind Treatment Phase (26 weeks) 
Subjects will enter the clinic in the morning prior to breakfast. Once the pre-dose fasting labs 
have been completed, subjects will be given breakfast except on Baseline Day 1.  
Baseline Clinic Visit: Day 1  
The following assessment will be done: 
• Inclusion/Exclusion criteria review 
• Vital signs including supine blood pressure, respiratory rate, heart rate, and temperature 
• Urine β-hCG (in pre-menopausal females)  
• Concomitant medication review 
• Adverse event review 
• Dispense study drug 
• Dispense patient diary 
• 12-lead ECG at Hour 1.5 ( ± 30 minutes)  post dose 
Once the pre-dose assessments have been completed, the subject will be administered the first 
dose of MN-001 (2 or 3 tablets of MN-001 250 mg) or matching placebo with water. 
Clinic Visits:  Months 1, 3 and 6* (± 5 days)  
The following assessments will be done: 
• Physical examination 
• Body weight 
• Vital signs including supine blood pressure, respiratory rate, heart rate, and temperature 
• 12-lead ECG at Hour 1.5 (± 30 min) post dose 

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• Fasting safety labs - chemistry (including CPK, liver enzymes, lipid panel) hematology, 
and urinalysis labs 
• Urine β-hCG (pre-menopausal females) 
• Blood Sample for biomarker (Month 6 only)  
• Pulmonary function test (Months 3 and 6 only) 
• 6MWT (Months 3  and 6 only)** 
• Dyspnea score ( MMRC)  
• ATAQ-IPF (Months 3 and 6 only)  
• Adverse event review 
• Concomitant medication review 
• Patient diary review  
• Dispense study drug (Months 3 and 6 only)  
• Study drug accountability 
* Month 6 Clinic Visit is the start day (Day 1) of the Open-Label Extension (OLE) phase.  All 
subjects will take MN-001 750 mg bid or 500  mg tid. 
** Two tests should be performed for 6MWT 
 
Telephone Visits Week 1 (± 3 days) and Month 4 (± 5 days)  
Between clinic visits, subjects will be called by a study team member (e.g., study coordinator or 
nurse) to collect information regarding their health status.  The MMRC will be administered 
(only Month 4) and adverse events and concomitant medications will be documented. 
 
8.8.1.3  
Open-Label Extension Phase (26 weeks)  
Clinic Visits Visit: Month 7, 9 and 12 (± 5 days)  
The following assessments will be done:  
• Physical examination 
• Body weight 
• Vital signs including supine blood pressure, respiratory rate, heart rate, and temperature 
• 12-lead ECG at Hour 1.5 ( ± 30 min) post dose  
• Fasting safety labs - chemistry (including CPK, liver enzymes, lipid panel) hematology, 
and urinalysis labs 
• Urine β-hCG (pre-menopausal females) 

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• Blood Sample for biomarker (Month 12 only)  
• Pulmonary function test (Months 9 and 12 only) 
• 6MWT (Months 9 and 12 only) 
• Dyspnea score (MMRC)  
• ATAQ-IPF (Months 9 and 12 only)  
• Adverse event review 
• Concomitant medication review 
• Patient diary review (and collect at Month 12) 
• Dispense study drug (Month 9)  
• Study drug accountability 
• Study drug return (at Month 12) 
 
Telephone Visits:  Week 27 (± 3 days), Month 10 (± 5 days) 
Between clinic visits, subjects will be called by a study team member (e.g., study coordinator or 
nurse) to collect information regarding their health status.  The MMRC (Month 10 only) will be 
administered and adverse events and concomitant medications will be documented. 
 
8.8.1.4  
Follow-up / Laboratory Re-test Visits/ Early termination visit  
Follow up clinic visit: Month 13 (± 5 days)  
• Physical examination 
• Body weight 
• Vital signs including supine blood pressure, respiratory rate, heart rate, and temperature 
• Adverse event review 
• Concomitant medication review 
Laboratory Re-test visit 
Subjects who have clinically significant  abnormal lab finding will return for a laboratory re-test 
visit and will have the following assessments performed: 
• Fasting chemistry, hematology, or urinalysis lab, as indicated 
• Adverse event review 
• Concomitant medication review 
Early Termination visit  

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Subjects who discontinued study medication will undergo the following assessments:  
• Physical examination 
• Body weight 
• Vital signs including supine blood pressure, respiratory rate, heart rate, and temperature 
• Adverse event review 
• Concomitant medication review 
• Patient diary review and collect 
• Study drug accountability 
• Study drug return 
• 12-lead ECG** 
• Fasting safety labs - chemistry (including CPK, liver enzymes, lipid panel) hematology, 
and urinalysis labs** 
• Urine β-hCG (pre-menopausal females)** 
• Blood Sample for biomarker**  
• Pulmonary function test** 
• 6MWT**7 
• Dyspnea score (MMRC)**  
• ATAQ-IPF**  
** Assessment need not be performed if prior assessment occurred within 1 month of Early 
Termination Visit. 
8.8.2. 
Procedures/Assessment Details 
8.8.2.1. 
Informed Consent 
The Principal Investigator or a qualified designee (e.g., a licensed, qualified medical practitioner 
such as a physician’s assistant or a nurse practitioner) listed on Form FDA 1572 will explain the 
study to the subject, answer all of the subject’s questions, and obtain written informed consent 
before performing any study-related procedure. Informed Consent should be conducted in 
accordance with local requirements. Subjects should be able to verbally describe the benefits and 
risks associated with this study and what other treatment alternatives are available (as described 
in the consent form). Only subjects who provide informed consent, as assessed and documented 
by the Investigator, will be enrolled. 
8.8.2.2. 
Medical History  
A medical history obtained by the PI or qualified designee as listed on the Form FDA 1572.   

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8.8.2.3. 
Prior/Concomitant Medication Review 
Site study staff will record all medications used to treat Idiopathic Pulmonary Fibrosis taken 
within 1 month prior to screening visit in the CRF. Also, the following parameters will be 
recorded for all concomitant medications: drug name, route of administration, total daily dose, 
unit, frequency, start/stop dates, indication, and whether the medication was started after last 
dose of study medication.  The concomitant medications will subsequently be coded using the 
World Health Organization Drug Dictionary (WHO-DD).  
8.8.2.4. 
Physical Examination 
The physical exams must be performed by the PI or qualified designee (physician, physician’s 
assistant or nurse practitioner) listed on the Form FDA 1572. Clinically significant changes from 
the signing of the informed consent form (ICF) should be captured as AEs in the CRF. 
A complete physical examination includes the following assessments: general appearance, head, 
eyes, ears/nose/throat, neck, lymph nodes, skin, lungs, heart, abdomen, and musculoskeletal. If 
the subject is discontinued for any reason, every attempt should be made to perform a final 
physical examination. 
8.8.2.5. 
Vital Signs, Height, and Weight  
Blood pressure (BP) and heart rate (HR) measurements will be taken in a supine position. 
Respiratory rate and temperature will also be measured and all measurements will be recorded in 
the CRF. Clinically significant changes from baseline should be captured as AEs in the CRF. 
Weight will be measured in pounds.  Height (in inches) will be recorded only at Visit 2 
(Screening).   
8.8.2.6. 
Electrocardiogram (12-Lead ECG) 
All subjects will have standard resting 12-lead ECGs performed and interpreted. Subjects are to 
be supine for at least 5 minutes prior to ECG assessments. The time the ECG is performed will 
be recorded (using a 24-h clock).  
The PI or a qualified designee listed on Form Food and Drug Administration (FDA) 1572 must 
review, initial, and date the report, which must be filed in the subject’s study chart. Clinically 
significant findings at screening must be captured in the medical history.  Any clinically 
significant changes compared post study drug administration must be captured as an adverse 
event in the CRF. 
8.8.2.7. 
Pulmonary Function Test 
8.8.2.7.1. Forced Vital Capacity  
Forced vital capacity (FVC) is an index of respiratory function measured by a spirometry and an 
established measure of pulmonary function in IPF subjects. Forced vital capacity (FVC) is the 
volume of air that can forcibly be blown out after full inspiration measured in liters. FVC is the 
most basic maneuver in spirometry tests.   

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8.8.2.7.2.  Diffusing capacity of the lungs for carbon monoxide (DLCO) 
A test of the diffusing capacity of the lungs for carbon monoxide (DLCO) is one of the most 
clinically valuable tests of lung function. DLCO measures the ability of the lungs to transfer gas 
from inhaled air to the red cells in pulmonary capillaries (Macintyre et al 2005). This is quick, 
safe, and useful in the evaluation of both restrictive and obstructive disease.  
 
8.8.2.8. 
6-Minute Walk Test (6MWT)  
The indication for the 6MWT (ATS Guideline 2002) is for measuring the response to medical 
interventions in patients with moderate to severe heart or lung disease. Prior to the test, the 
participant should sit in a chair, located near the starting position for at least 10 minutes before 
assessing pulse and SpO2 (and Blood Pressure if not taken and recorded within 4 hours  prior to 
test).  The following items will be measured: 
• 
Change in 6MWT distance  
• 
Change in 6MWT oxygen saturation area under the curve using the same oxygen dose as 
the baseline (Visit 2)  
• 
Change in 6MWT minutes walked  
 
The full 6MWT guideline is found in Appendix 2. 
 
8.8.2.9. 
Modified Medical Research Council Dyspnea Score (MMRC)  
The Modified Medical Research Council scale (MMRC scale) is a simple grading system largely 
used in the assessment of dyspnea in chronic respiratory diseases, such as IPF or COPD. The 
MMRC breathlessness scale comprises five statements that describe almost the entire range of 
respiratory disability from “None” (Grade 1) to “Almost complete incapacity” (Grade 5). 
 
Table 5: Modified Medical Research Council Dyspnea Scale 
 
 

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8.8.2.10. ATAQ-IPF questionnaire 
ATAQ-IPF questionnaire is designed to determine how IPF affects the patient’s quality of life. 
There are 13 sections and a total of 74 questions to answer from “Strongly disagree” (Grade 1) – 
“Strongly agree” (Grade 5).  The full ATAQ-IPF questionnaire is found in Appendix 3. 
8.8.2.11. Worsening IPF 
Worsening IPF is defined as acute IPF exacerbation, hospitalization due to respiratory 
symptoms, IPF related fatal events, or lung transplantation. 
8.8.2.12. Adverse Event (AE) Monitoring  
The PI or a qualified designee listed on Form FDA 1572 must assess the severity and 
relationship to study medication for all AEs (see Section 12.2). 
All observed or volunteered AEs regardless of treatment group or suspected causal relationship 
to the investigational product(s) will be recorded on the AE page(s) of the CRF.  
Each PI and research team are responsible for identifying adverse events and reporting them. 
For all AEs, the Investigator must pursue and obtain information adequate to determine the 
outcome of the AE and to assess whether it meets the criteria for classification as an SAE (see 
Section 5) requiring immediate notification to the Sponsor or its designated representative.  
For all AEs, sufficient information should be obtained by the Investigator to determine the 
causality of the AE. The Investigator is required to assess causality and indicate that assessment 
on the CRF. For AEs with a causal relationship to the investigational product, follow-up by the 
Investigator is required until the event or its sequelae resolve or stabilize at a level acceptable to 
the Investigator, and Sponsor concurs with that assessment.  
Adverse events (serious and non-serious) including all suspected unexpected serious adverse 
reactions (SUSARs) should be recorded on the CRF from the date of informed consent until the 
end of their participation in the study (i.e., the subject has discontinued or completed the follow-
up visit). 
8.8.2.13. Laboratory Evaluations 
Laboratory evaluations will include the tests listed in Appendix 1. 

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9. 
STUDY DRUG MATERIALS AND MANAGEMENT 
9.1. 
Study Drug 
 
Table 6: Study Drug Information 
Investigational Drug: 
MN-001 or matching placebo 
Formulation: 
250 mg tablet (MN-001) or matching placebo 
Frequency: 
250 mg  3 tablets (750 mg)  bid, 2 tablets (500 mg) tid, or matching 
placebo  
Storage Conditions: 
Store at room temperature  
9.2. 
Study Drug Packaging and Labeling 
 
At a minimum the following information will be included on each bottle:  
• 
Name of Sponsor  
• 
Study number/Acronym/IND number 
• 
Route of administration 
• 
Quantity of dosage unit 
• 
Directions for use 
• 
Storage conditions 
• 
Space for information to be completed by Investigator/designee: 
o Name and telephone number of Investigator 
o Dispensing date 
o Subject number 
• 
Statement “Caution: New Drug – Limited by federal law to investigational use” 
• 
Statement: “Keep out of reach of children” 
9.3. 
Study Drug Storage 
The clinical study drug MN-001 should be stored at room temperature (preferably 18-230C, but 
15-250C is acceptable). 
9.4. 
Study Drug Administration 
The study drug will be dispensed by appropriately qualified site study staff as indicated on the 
delegation of authority log. Subjects will self-administer the study drug at home except on clinic 
visit days (Day1, Months 1, 3, 6, 7, 9 and 12). On those days, subjects will be instructed to wait 
until they come to the clinic to take their study medication. The subject will be instructed to 
return all unused study drug to the clinical trial site at each visit. 

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9.5. 
Study Drug Accountability 
Investigational clinical supplies must be received by the PI or a designated person at the study 
site, handled and stored safely and properly, and kept in a secured location to which only the 
Investigator and/or designated assistants have access. Clinical supplies are to be dispensed only 
in accordance with the protocol.  
The PI or designee is responsible for keeping accurate records of the clinical supplies received 
from the Sponsor or designee, the amount dispensed to and returned by the subjects, and the 
amount remaining at the conclusion of the study. At the end of the study, all clinical supplies 
must be returned to the Sponsor, or designee, after confirmation with the CRA (Clinical 
Research Associate) or destroyed at the clinical site. Study drug will not be destroyed until 
written documentation is received from the study sponsor or designee. Proper documentation of 
the destruction of study drug must be provided by the site. 
The following information is to be included in the CRF: visit medication dispensed, dosing 
start/stop dates, dosage level, number of tablets dispensed and number of tablets returned. 

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10. 
EFFICACY ASSESSMENTS 
Efficacy will be assessed by the following:  
• Absolute and relative change from baseline of FVC and FVC% predicted up to  26 weeks 
• Semiannual decline on disease activity based on FVC 
• Annual/semiannual decline on disease activity based on the 6-minute walk test (6MWT) 
• Modified Medical Research Council Dyspnea Score (MMRC)  
• Quality of life (QOL)  measured by A Tool to Assess Quality of Life in Idiopathic 
Pulmonary Fibrosis (ATAQ-IPF)  
• Frequency of  worsening IPF 
• Time to first worsening IPF 

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11. 
SAFETY AND TOLERABILITY ASSESSMENTS 
 
Safety will be assessed by the proportion of subjects with the following events: 
• Clinical and laboratory treatment emergent adverse events (TEAEs) 
• Discontinuations due to TEAEs 
• Treatment emergent serious adverse events (TESAEs) 
Safety (relationship and severity) and tolerability will further be assessed by statistical and 
clinical review of AEs, laboratory values, ECGs, physical examinations, vital signs and weight.  
 
 

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12. 
ADVERSE EVENTS 
12.1. 
Definition of Adverse Events 
An AE is any untoward medical occurrence in a study subject administered a medicinal 
(investigational) product and which does not necessarily have a causal relationship with this 
treatment. An AE can therefore be any unfavorable and unintended sign (including a clinically 
significant abnormal laboratory finding), symptom, or disease temporally associated with the use 
of a medicinal (investigational) product, whether or not considered related to the medicinal 
(investigational) product. Adverse events may include the onset of a new illness and the 
exacerbation of pre-existing conditions. 
Other untoward events occurring in the framework of a clinical study are also to be recorded as 
AEs, (e.g., those occurring during treatment-free periods, including screening or post-treatment 
follow-up periods), in association with study-related procedures and assessments or under 
placebo.  
12.2. 
Assessment of Adverse Events 
The PI or an authorized physician will assess all AEs for severity, relationship with study 
medication, and whether it meets the criteria for classification as a SAE, requiring immediate 
notification to the Sponsor or designee (see Section 12.5). These assessments will be made in 
accordance with the standard ratings detailed in the following sections. 
12.2.1. 
Severity Assessment 
The severity of AEs will be determined as described in Table 7. 
 
Table 7: Adverse Events Severity Definition 
Mild 
Grade 1 
Ordinarily transient symptoms that do not influence performance of subject’s daily 
activities. Treatment is not ordinarily indicated. 
Moderate 
Grade 2 
Marked symptoms sufficient to make the subject uncomfortable. Moderate influence on 
performance of subject’s daily activities. Treatment may be necessary. 
Severe 
Grade 3 
Symptoms cause considerable discomfort. Substantial influence on subject’s daily 
activities. May be unable to continue in the study and treatment may be necessary. 
Life-
threatening 
Grade 4 
Extreme limitation in activity, significant assistance required; significant 
medical/therapy intervention required hospitalization probable. 
Death 
Grade 5 
Death. 
 

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When changes in the intensity of an AE occur more frequently than once a day, the maximum 
intensity for the event should be noted for that day. Any change in severity of signs and 
symptoms over a number of days will be captured by recording a new AE, with the amended 
severity grade and the date (and time, if known) of the change. 
12.2.2. 
Relationship to Study Drug 
One of the following categories in Table 8 should be selected based on medical judgment, 
considering the definitions below and all contributing factors. 
 
Table 8: Adverse Events Causality Definition 
Related 
 
A clinical event, including laboratory test abnormality, occurs in a 
plausible time relationship to treatment administration, and which 
cannot be explained by concurrent disease or other medications or 
chemicals. The response to withdrawal of the treatment (dechallengea) 
should be clinically plausible. The event must be definitive 
pharmacologically or phenomenologically, using a satisfactory 
rechallengeb procedure if necessary. 
Probably 
related 
 
A clinical event, including laboratory test abnormality, occurs within a 
reasonable time sequence to administration of the treatment, unlikely to 
be attributed to concurrent disease or other medications or chemicals, 
and which follows a clinically reasonable response on withdrawal 
(dechallenge). Rechallenge information is not required to fulfill this 
definition. 
Possibly related 
 
A clinical event, including laboratory test abnormality, occurs within a 
reasonable time sequence to administration of the treatment, but which 
could also be explained by concurrent disease or other medications or 
chemicals. Information on treatment withdrawal may be lacking or 
unclear. 
Unlikely to be 
related 
 
A clinical event, including laboratory test abnormality, occurs with a 
temporal relationship to treatment administration that makes a causal 
relationship improbable, and in which other medications, chemicals, or 
underlying disease provide plausible explanations. 
Unrelated 
 
A clinical event, including laboratory test abnormality, occurs with 
little or no temporal relationship with treatment administration. May 
have negative dechallenge and rechallenge information. Typically 
explained by extraneous factors (e.g., concomitant disease, 
environmental factors, or other medications or chemicals). 
a Dechallenge is when a medication suspected of causing an AE is discontinued. If the symptoms of the AE 
disappear partially or completely, within a reasonable time from medication discontinuation, this is termed a 
positive dechallenge. If the symptoms continue despite withdrawal of the medication, this is termed a negative 
dechallenge. Note that there are exceptions when an AE does not disappear upon discontinuation of the 
medication, yet medication-relatedness clearly exists (e.g., as in bone marrow suppression, fixed medication 
eruptions, or tardive dyskinesia) 

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b Rechallenge is when a medication suspected of causing an AE in a specific subject in the past is readministered to 
that subject. If the AE recurs upon exposure, this is termed a positive rechallenge. If the AE does not recur, this is 
termed a negative rechallenge. 
 
12.3. 
Recording Adverse Events 
Adverse events should be collected and recorded for each subject from the date that the first 
study dose was taken until the end of their participation in the study (i.e., the subject has 
discontinued or completed the study).  Only those AEs that occurred while on study drug that 
have not been resolved will be followed until resolution or stabilization. 
Following the end of the subject’s participation in the study, the PI or an authorized delegate 
should report SAEs “spontaneously” if considered at least possibly related to study medication. 
Adverse events may be volunteered spontaneously by the study subject, or discovered by the 
study staff during physical examinations or by asking an open, non-leading question such as, 
“How have you been feeling since you were last asked?” All AEs and any required remedial 
action will be recorded in the subject’s source documentation and transcribed onto the 
appropriate CRF page for the study period indicated. The nature of AE, date (and time, if known) 
of AE onset, date (and time, if known) of AE outcome to date, severity, and action taken of the 
AE will be documented together with the PIs or an authorized physician’s assessment of the 
seriousness of the AE and causal relationship to study medication and/or study procedure (at the 
time of assessment). 
All AEs should be recorded individually in the study subject’s own words (verbatim) unless, in 
the opinion of the PI or an authorized physician, the AEs constitute components of a recognized 
condition, disease, or syndrome. In the latter case, the condition, disease, or syndrome should be 
named rather than each individual symptom. The AEs will subsequently be coded using the 
MedDRA. 
12.4. 
Treatment and Follow-Up of AEs 
Appropriate measures should be taken to treat AEs as necessary, and the response of the study 
subject should be monitored and recorded. Clinical, laboratory, and diagnostic measures should 
be obtained as needed, and the results of which should be recorded in the subject’s source 
documentation and transcribed onto the appropriate CRF page. 
All SAEs will be followed until resolution, stabilization of the condition, the event is otherwise 
explained, or the subject is lost to follow-up. 
12.5. 
Serious Adverse Events (SAEs) 
An AE is considered serious if it meets one or more of the following criteria: 
• Results in death 
• Is life-threatening (i.e., a subject is at immediate risk of death at the time of the event, not 
an event where occurrence in a more severe form might have caused death) 

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• Requires inpatient hospitalization or prolongation of existing hospitalization 
• Results in persistent or significant disability/incapacity 
• Results in a congenital anomaly/birth defect 
• Is another important medical event (see below). 
Important medical events that do not result in death, are not life-threatening, or do not require 
hospitalization may be considered SAEs when, based on appropriate medical judgment, they 
may jeopardize the subject and may require medical or surgical intervention to prevent one of the 
outcomes listed above. Examples of such medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or in a physician’s office, blood dyscrasia or 
seizures that do not result in inpatient hospitalization, and the development of drug dependency 
or drug abuse. A distinction should be drawn between serious and severe AEs. Severity is a 
measure of intensity whereas seriousness is defined by the criteria above. For example, a mild 
degree of gastrointestinal bleeding requiring an overnight hospitalization for monitoring 
purposes would be considered an SAE, but is not necessarily severe. Similarly, an AE that is 
severe in intensity is not necessarily an SAE. For example, alopecia may be assessed as severe in 
intensity, but would probably not be considered an SAE. 
12.5.1. 
SAE Reporting Requirements 
The PI or an authorized delegate is responsible for faxing the requested information to the 
Sponsor or designee within 24 hours or as soon as possible after learning of the event. Following 
the end of the subject’s participation in the study, the PI or an authorized delegate should report 
SAEs “spontaneously” if considered at least possibly related to study medication. 
Notification should be made by emailing a completed SAE Report Form to the Sponsor. Study 
sites in the US should email a completed SAE Report Form to 
Safetymonitors@medicinova.com. As a minimum requirement, the initial notification should 
provide the following information: 
• Study number 
• Subject number 
• Gender 
• Date of birth 
• PI’s name and full study site address 
• Details of SAE 
• Criterion/criteria for classification as “serious” 
• Study medication name, or code if blinded, and treatment start date 
• Date of SAE onset 
• Causality assessment (if sufficient information is available to make this classification). 

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Initial reports of SAEs must be followed later with detailed descriptions, including clear 
photocopies of other documents as necessary (e.g., hospital reports, consultant reports, autopsy 
reports, etc.), with the study subject’s personal identifiers removed. All relevant information 
obtained by the PI or an authorized delegate through review of these documents will be recorded 
on the AE eCRF page and/or a new SAE Report Form and faxed to the Sponsor or designee 
within 24 hours of receipt of the information. If a new SAE Report Form is faxed, the PI must 
sign and date the form. The Sponsor may also request additional information on the SAE, which 
the PI or an authorized delegate must fax to the Sponsor or designee within 24 hours of the 
request using a new SAE Report Form, bearing the PI’s signature and date. 
Any AE fulfilling the criteria for expedited reporting will be reported by the Sponsor to 
regulatory authorities and Investigators and IEC(s) in accordance with the Sponsor’s standard 
operating procedures (SOPs) and local regulatory requirements. 
PIs should report all Investigational New Drug Application safety alerts received from the 
Sponsor to their local IRB/IECs. 
12.6. 
Guidance for Overdose  
There is no clinical experience with MN-001 overdose in humans and there is no available 
specific antidote to the effects of MN-001. Standard symptomatic support measures should be 
used in the case of excessive pharmacological effects or overdose. 
12.7. 
 Reporting and Follow-up of Pregnancies 
If any study subject or subject’s partner becomes pregnant after receiving the first dose of study 
medication (MN-001) and until the follow-up period specified in the protocol, the PI or an 
authorized delegate should submit a Pregnancy Report Form to the sponsor within 24 hours of 
the PI or an authorized delegate first becoming aware of the pregnancy.  If a pregnancy is to be 
terminated, the anticipated date of termination should also be provided in the “Additional 
Information/Comments” field of the Pregnancy Report Form. If a maternal SAE is reported for 
the study subject during the initial notification of pregnancy, a separate SAE Report Form should 
also be completed and submitted to the sponsor within 24 hours of the PI or an authorized 
delegate first becoming aware of the SAE.  
Subjects who become pregnant while in the study should be followed for the duration of their 
pregnancy.  If the pregnancy is discovered between regularly scheduled study visits, subjects 
should return for an unscheduled visit to return their study medication.  A quantitative β-hCG 
should be obtained and subjects should be encouraged to return for follow-up visits.   If follow-
up visits are not possible, then the principal investigator should collect information about the 
pregnancy such as spontaneous or elective termination, details of birth, and presence or absence 
of birth defects, congenital abnormalities, or maternal and newborn complications. 
The Sponsor will request that the PI follow the progress of the study subject’s pregnancy with 
the doctor medically responsible for the pregnancy. A new Pregnancy Report Form should be 
submitted within 24 hours of the PI or an authorized delegate first becoming aware of any new 
information. 

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If additional information on the outcome of the pregnancy and/or the details of the birth/delivery 
is received “spontaneously” by the study site, the PI or authorized delegate should also submit a 
Pregnancy Report Form within 24 hours of becoming aware of the information. If the outcome of 
the pregnancy is reported as premature birth, or as elective termination due to a medical reason 
or as spontaneous or accidental miscarriage, the details of the outcome should be described in the 
“Additional Information/Comments” field of the Pregnancy Report Form. The pregnancy 
outcome will generally be reported as a follow-up report.  
Complete an SAE Report Form if the delivery outcome meets the criteria for a SAE (e.g., 
congenital anomaly/birth defect, stillbirth, some other sickness, etc.). The SAE Report Form 
should be completed with the study subject’s details (e.g., subject number, initials, date of birth, 
investigational product information, etc.) and the details of the fetal SAE and maternal 
complications should be described in the “Narrative” field of the SAE Report Form. 
If a pregnancy is reported for the study subject’s partner, the sponsor will provide instructions on 
how to collect pregnancy information in accordance with local requirements. 
12.8. 
Preplanned Hospitalizations or Procedures 
During the study, if a subject has a hospitalization or procedure (e.g., elective surgery) that was 
scheduled prior to the subject entering the study (i.e., before the subject signed the ICF) for an 
event/condition that occurred before the study, the hospitalization is considered a therapeutic 
intervention and not the result of an SAE. However, if the event/condition worsens during the 
study, it must be reported as an AE or SAE (if the event/condition results in a serious outcome 
such as prolongation of hospitalization.) 

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13. 
STATISTICS 
The Statistical Analysis Plan (SAP) will provide comprehensive details on the statistical methods 
planned for this study. 
13.1. 
Data Analysis 
13.1.1. 
Analysis Populations 
Full Analysis Set (FAS) will include all enrolled subjects who receive at least one dose of study 
medication, and have at least one post efficacy assessment. 
Safety Analysis Set will include all subjects who received at least one dose of study drug and had 
at least one post dose safety assessment. 
13.1.2. 
Statistical Analysis Plan 
A statistical analysis plan will outline the efficacy analysis and safety analysis prior to database 
lock. 
13.1.3. 
Sample Size Justification 
No prior data are available on which to base assumptions for sample size/power considerations.  
The results of this pilot study will be used to design future studies, and the sample size of 
approximately 15 subjects is deemed to be appropriate for this purpose.  
 
13.1.4. 
Safety Analysis 
Safety analyses will be conducted on the Safety Analysis Set. 
 
The incidence of treatment-emergent AEs (TEAEs, defined as AEs occurring from the time of 
first dose through 7 days after the last dose of study medication), SAEs and AEs leading to 
discontinuations will be summarized by treatment group.  Incidence of TEAEs will also be 
summarized by severity (mild, moderate, or severe), as well as by relationship to treatment (not 
related, possibly related, or probably related) and by seriousness. 
 
Changes from baseline in laboratory values will be summarized by treatment groups for 
continuous variables.  Lab shift tables showing incidence of new or worsening clinically 
significant findings from baseline to the last visit will be displayed by treatment groups.  Shift 
from baseline to the highest lab value, and from baseline to the lowest lab value will also be 
displayed. 
 
Incidence of out-of-normal-range values and markedly abnormal change from baseline in 
laboratory safety test variables will be tabulated by treatment group.  
 
Changes in vital signs from baseline to each visit will be summarized by treatment groups. 
 

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13.2. 
 
Direct Access To Source Data/Documents 
By signing this protocol, the PI agrees to conduct the study in an efficient and diligent manner 
and in conformance with this protocol; generally accepted standards of Good Clinical Practice 
(GCP); and all applicable federal, state, and local laws, rules and regulations relating to the 
conduct of the clinical study. 
The PI also agrees to allow monitoring, audits, and regulatory agency inspection of study-related 
documents and procedures and provide for direct access to all study-related source data and 
documents. 
The PI shall prepare and maintain complete and accurate study documentation in compliance 
with GCP standards and applicable federal, state, and local laws, rules, and regulations; and, for 
each subject participating in the study, provide all data, and upon completion or termination of 
the clinical study submit any other reports to the Sponsor, or its designee, as required by this 
protocol or as otherwise required pursuant to any agreement with the Sponsor. 
Study documentation will be promptly and fully disclosed to the Sponsor, or its designee, by the 
PI upon request and shall also be made available at the PI’s site upon request for inspection, 
copying, review, and audit at reasonable times by representatives of the Sponsor or any 
regulatory agencies. The PI agrees to promptly take any reasonable steps that are requested by 
the Sponsor, or its designee, as a result of an audit to address deficiencies in the study 
documentation and worksheets/CRFs.  
The PI will promptly inform the Sponsor or its designee of any regulatory agency inspection 
conducted for this study. 
Persons debarred from conducting or working on clinical studies by any court or regulatory 
agency will not be allowed to conduct or work on this Sponsor’s studies. The PI will 
immediately disclose in writing to the Sponsor or its designee if any person who is involved in 
conducting the study is debarred, or if any proceeding for debarment is pending or, to the best of 
the Investigator’s knowledge, threatened. 
13.3. 
Study Monitoring  
Monitoring will include on-site monitoring to assure that the investigation is conducted 
according to protocol, to protect subject rights and safety, and to confirm data integrity and 
quality.  
This study will be monitored through all phases of study conduct by the Sponsor or its 
representative. Monitoring will include personal visits and telephone communication to assure 
that the investigation is conducted according to protocol and in order to comply with guidelines 
of GCP. On-site review of CRFs will include a review of forms for completeness and clarity, and 
consistency with source documents available for each subject. Investigators will be required to 
store all source documents.  

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13.4. 
Audits and Inspections 
The PI and appropriate personnel may be periodically requested to attend meetings organized by 
the Sponsor or its designee to assure acceptable protocol execution. The study may be subject to 
audit by the Sponsor/designee or by regulatory authorities. If such an audit occurs, the PI must 
agree to allow access to required subject records. By signing this protocol, the Investigator grants 
permission to personnel from the Sponsor, its representatives, and appropriate regulatory 
authorities for on-site monitoring and auditing of all appropriate study documentation, as well as 
on-site review of the procedures employed in CRF generation, where clinically appropriate. The 
PI has to inform the Sponsor if he/she is approached for a regulatory audit.  
13.5. 
Institutional Review Board (IRB) 
Before initiation of the study, the PI must obtain approval of the research protocol, informed 
consent form (ICF), and any advertisement for subject recruitment from the IRB complying with 
the provisions specified in the Code of Federal Regulations (CFR) 21 Part 56 and applicable 
government regulations. A copy of written IRB approval of the protocol, ICF, and advertising (if 
applicable) must be provided to the Sponsor or their designee prior to initiation of the study.  
13.6. 
Study Documentation 
By signing a copy of Form FDA 1572, the Investigator acknowledges that he/she has received a 
copy of the investigational drug brochure on MN-001 and assures the Sponsor that he/she will 
comply with the protocol and the provisions stated in Form FDA 1572. No changes in this 
protocol can be made without the Sponsor’s written approval.  
The Investigator will supply the Sponsor with the following:  
1. Original, signed Form FDA 1572  
2. Curricula vitae for all Investigators listed on Form FDA 1572  
3. Copy of the Investigator’s medical licensure/medical registration number  
4. Signed protocol signature page  
5. Signed IB signature page 
6. Financial disclosure forms for all study staff listed on the FDA 1572.  

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14. 
QUALITY CONTROL AND QUALITY ASSURANCE 
 
By signing this protocol, the Sponsor and Clinical Study Sites Principal Investigator agree to be 
responsible for implementing and maintaining quality control and quality assurance systems with 
written standard operating procedures (SOPs) reviewed and approved by the sponsor to ensure 
that the study is conducted and data are generated, documented, and reported in compliance with 
the protocol, accepted standards of GCP, and all applicable federal, state, and local laws, rules 
and regulations relating to the conduct of the clinical study. 

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15. 
ETHICS 
15.1. 
Ethics Review 
Documented approval from the IRB will be obtained for all participating centers prior to clinical 
trial start, according to ICH (International Conference on Harmonisation) GCP, local laws, 
regulations and organization. When necessary, an extension, amendment or renewal of the CIRB 
approval must be obtained. 
15.2. 
Ethical Conduct of the Study 
The procedures set out in this clinical trial protocol pertaining to the conduct, evaluation, and 
documentation of this clinical trial, are designed to ensure that the Sponsor and Principal 
Investigator abide by Good Clinical Practice Guidelines (GCP in the appropriate current 
version). The clinical trial will also be carried out in accordance with applicable local law(s) and 
regulation(s). This may include an inspection by representatives from MediciNova Inc. and/or 
Regulatory Authority representatives at any time. The PI must agree to the inspection of clinical 
trial-related records by MediciNova, Inc. representatives, and must allow representatives direct 
access to source documents. 
15.3. 
Written Informed Consent 
An information and consent form will be provided to the subject. The process of obtaining 
informed consent must be in accordance with applicable regulatory requirements, and must 
adhere to GCP and ethical principles in the Declaration of Helsinki. Written informed consent 
must be obtained and documented before any clinical trial-specific procedure takes place. 
Participation in the clinical trial and date of informed consent given by the subject must be 
documented in the subject files. 
15.4. 
Confidentiality 
15.4.1. 
Confidentiality of Data 
By signing this protocol, the Investigator affirms to the Sponsor that information furnished to the 
Investigator by the Sponsor will be maintained in confidence and such information will be 
divulged to the IRB or similar or expert committee; affiliated institution; and employees only 
under an appropriate understanding of confidentiality with such board or committee, affiliated 
institution and employees.  
 

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16. 
DATA HANDLING AND RECORDKEEPING 
16.1. 
Review of Records 
The results from Screening and data collected during the study will be recorded in the subject’s 
CRF, which will be designed and provided by the sponsor or a designee. The Investigator will 
review all CRFs. The CRFs will be signed by the PI or a sub-Investigator who is listed on the 
Form FDA 1572 if the PI is unavailable. In order to maintain confidentiality, the subject will be 
identified only by his/her subject number and initials. 
16.2. 
Retention of Records 
The PI must arrange for retention of study records at the site for at least two years after the New 
Drug Application (NDA) is approved or Investigational New Drug (IND) is withdrawn, as 
required by the US Food and Drug Administration (FDA) regulations, or in accordance with 
local and/or national requirements, whichever is longer. The PI should take measures to prevent 
accidental or premature destruction of these documents. Documents cannot be destroyed without 
written Sponsor authorization. The Sponsor will inform the PI when the destruction of 
documents is permitted.  

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17. 
ADMINISTRATIVE AND REGULATORY DETAILS 
17.1. 
Protocol Amendments and Study Termination  
All revisions and/or amendments to this protocol must be approved in writing from the Sponsor 
and the IRB, except where necessary to eliminate an apparent immediate hazard to a study 
subject. 
17.2. 
Discontinuation of the Study  
The Sponsor reserves the right to discontinue the study at site(s) for safety or administrative 
reasons at any time. For example, a site that does not recruit at an acceptable rate may be 
discontinued. Should the study be terminated and/or the site closed for whatever reason, all 
documentation and study medication pertaining to the study must be returned to the Sponsor or 
its representative.  
17.3. 
Compliance with Financial Disclosure Requirements 
By signing this protocol, the PI agrees to provide to the Sponsor accurate financial information to 
allow the Sponsor to submit complete and accurate certification and disclosure statements as 
required by the US FDA regulations (21 CFR Part 54). The PI further agrees to provide this 
information on a Financial Disclosure/Certification Form that is provided by MediciNova Inc. 
The Investigator will update this information if there are any relevant changes during the conduct 
of the study and for one year after completion of the study. This requirement also extends to sub-
Investigators. The PI also consents to the transmission of this information to MediciNova Inc. for 
these purposes.  

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18. 
REFERENCES 
 
Ashcroft T, Simpson JM, Timbrell V. Simple method of estimating severity of pulmonary 
fibrosis on a numerical scale. J Clin Pathol 1988 Apr; 41(4):467-70. 
Beller TC, Maekawa A, Friend DS, Austen KF, Kanaoka Y. Targeted gene disruption reveals the 
role of the Cysteinyl Leukotriene 2 receptor in increased vascular permeability and in 
bleomycin-induced pulmonary fibrosis in mice. J Biol Chem 2004; 279:46129–34.  
Funk, CD. Prostaglandins and leukotrienes: advance in eicosanoid biology. Science 2001 Nov 
30; 294(5548):1871-5. 
 
Holland AE, Spruit MA, Troosters T, et al. An official European Respiratory Society/American 
Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Resp J 
2014; 44:1428-46. 
King TE, Bradford WZ, Castro-Bernardini S, et al. A Phase 3 Trial of Pirfenidone in Patients 
with Idiopathic Pulmonary Fibrosis. N Engl J Med 2014 May 29;370(22):2083-92. 
Macintyre N, Crapo RO, Viegi G, Johnson DC, van der Grinten CP, Brusasco V, Burgos F, 
Casaburi R, Coates A, Enright P, Gustafsson P, Hankinson J, Jensen R, McKay R, Miller MR, 
Navajas D, Pedersen OF, Pellegrino R, Wanger Standardisation of the single-breath 
determination of carbon monoxide uptake in the lung. Eur Respir J 2005 Oct; 26(4):720-35. 
Raghu G, Collard HR, Egan JJ, et al. An Official ATS/ERS/JRS/ALAT Statement: Idiopathic 
Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. Am J Respir 
Crit Care Med 2011 Mar 15; 183(6):788-824. 
Richeldi L, du Bois RM, Raghu G, et al. Efficacy and safety of nintedanib in idiopathic 
pulmonary fibrosis. N Engl J Med 2014 May 29; 370(22):2071-82. 
Samuelsson, B, SE Dahlen, JA Lindgren, CA Rouzer, and CN Serhan. Leukotrienes and 
lipoxins: structures, biosynthesis, and biological effects. Science 1987; 237:1171-6. 
 
Shim YM, Zhu Z, Zheng T, Lee CG, Homer RJ, Ma B, Elias JA. Role of 5-Lipoxygenase in IL-
13-Induced Pulmonary Inflammation and Remodeling. J Immunol 2006; 177:1918-24. 
 
Singh SJ, Puhan MA, Andrianopoulos V et al. An official systematic review of the 
European Respiratory Society/American Thoracic Society: measurement properties of field 
walking tests in chronicrespiratory disease. Eur Resp J 2014; 44:1447-8. 
 
Wilborn J, Bailie M, Coffey M, Burdick M, Strieter R, Peters-Golden M. Constitutive Activation 
of 5-Lipoxygenase in the Lungs of Patients with Idiopathic Pulmonary Fibrosis. J Clin Invest 
1996; 97:1827-36. 

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19. 
APPENDICES 
 
Appendix 1: Laboratory Safety Tests for MN-001 
Appendix 2: 6-minute walk test guideline 
Appendix 3: ATAQ-IPF Questionnaire 
Appendix 4: Model Informed Consent 
 
 
 

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Appendix 1: Laboratory Safety Tests for MN-001 
 
 
Blood Chemistry Tests 
 
aspartate aminotransferase (AST) 
 
alanine aminotransferase (ALT) 
 
albumin  
 
alkaline phosphatase  
 
bicarbonate  
 
blood urea nitrogen  
 
calcium  
 
chloride  
 
creatinine  
              creatine phosphokinase (CPK) 
 
gamma-glutamyl transferase  
 
phosphorous  
 
potassium  
 
sodium  
 
total bilirubina 
 
total protein  
 
lactate dehydrogenase  
 
triglyceride  
 
serum cholesterol  
 
serum high-density lipoprotein cholesterol  
 
serum low-density lipoprotein cholesterol  
 
glucose  
 
Endocrine Tests 
 
serum beta-human chorionic gonadotropin (for females of childbearing potential) 
 
urine beta-human chorionic gonadotropin  
 
Hematology Tests 
 
white blood cell count 
 
white blood cell differential 
 
eosinophilic leukocyte count 
 
basophilic leukocyte count 
 
neutrophil count 
 
lymphocyte count 
 
monocyte count 
 
platelet count 
 
hemoglobin  
 
blood hematocrit 
 
red blood cell count 
 
red cell distribution width  
 
red blood cell indices: 
 
mean corpuscular volume 
 
mean corpuscular hemoglobin concentration 
 
mean corpuscular hemoglobin 
 
Urinalysis Tests 
 
color  
 
appearance  
 
total ketones  
 
urobilinogen  
 
bilirubin  

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red blood cells 
 
leukocyte esterase  
 
nitrite  
 
pH  
 
protein  
 
specific gravity  
 
glucose  
 
microscopic evaluationb 
a Bilirubin will be fractionated (direct serum bilirubin test/indirect serum bilirubin test) if elevated 2.0 times the 
upper limit of the normal range. 
b Microscopic evaluation will be performed if dipstick analysis indicates the presence of any significant 
abnormality. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 2:  6-minute walk test guideline  
 
 

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Appendix 3:  ATAQ-IPF Questionnaire 

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Appendix 4:  Model Informed Consent  
 
 

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