A Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an Intravenous Monoclonal Antibody (mAb) After Single Ascending Doses in Subjects Affected by Idiopathic Pulmonary Fibrosis.
Phase: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Chiesi Farmaceutici S.p.A.

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CLINICAL STUDY PROTOCOL 
STUDY CODE No.: CLI-10067AA1-01
EUDRACT No.: 2022-001079-15
A PHASE IB, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED 
STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND 
PHARMACOKINETICS OF AN INTRAVENOUS MONOCLONAL ANTIBODY 
(MAB) AFTER SINGLE ASCENDING DOSES IN SUBJECTS AFFECTED BY 
IDIOPATHIC PULMONARY FIBROSIS
Version No.: 6.0
Date: 06 July 2023
The information contained in this document is confidential and will not be disclosed to others without written 
authorisation from Chiesi Farmaceutici S.p.A., except to the extent necessary to obtain informed consent from 
those persons to whom the drug may be administered or for discussions with local regulatory authorities, Ethics 
Committee/Investigational Review Boards, or people participating in the conduct of the study.
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma – Italy
NCT05513950

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VERSION HISTORY
Version 
Date 
Change History
1.0
03 May 2022
First version
2.0
25 August 
2022
Protocol version 2.0 (dated 25 August 2022) incorporated the 
following changes into protocol version 1.0 (dated 03 May 
2022) based on Medicines and Healthcare products Regulatory 
Agency (MHRA) feedback:

Section 6.2.2.1 Dose escalation stopping rule was 
updated: ‘Three or more subjects on active drug* 
experience a severe, possibly drug-related AE lasting 
for > 24 hours duration’ is replaced by ‘two or more 
subjects on active drug* experience a severe, possibly 
drug-related AE lasting for > 24 hours duration’. 

Section 10.3 Intensity of Adverse Event was amended 
so that the Common Terminology Criteria for Adverse 
Events (CTCAE) would be used as the adverse event 
severity grading scale rather than a 3-point severity 
grading scale with CTCAE. 

Section 12.3.5.1 Adverse Events was amended to 
change the statistical analysis so that treatment-
emergent adverse event data will be summarised by 
CTCAE grade rather than severe intensity. 
3.0 
24 
October 
2022
See the list of substantial changes in the summary of 
changes dd 24 October 2022.
4.0
22 May 2023
Protocol version 4.0 (dated 22 May 2023) removed the 
bronchoscopy procedure from protocol version 3.0 (dated 
24 October 2022) based on MHRA feedback in the following 
sections:

Section 1.3 Risk/Benefit Assessment

Section 4.1 Subject Recruitment

Section 7.1 Study Schedule – All Cohorts

Section 7.1.2 Optional Additional Visit for 
Bronchoscopy

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
Section 7.2.12 Optional Bronchoscopy for 
Bronchoalveolar Lavage and Bronchoabsorption 
Assessment

Section 25 References
5.0
16 June 2023
See the list of the substantial changes in the Summary of 
Changes dated 16 June 2023.
6.0
06 July 2023
Non substantial changes to correct inconsistencies related to 
the timing of vital signs and oxygen saturation assessments:
Section 7.1 Footnotes for Evaluation Schedule 
Section 7.2.7.3 Oxygen Saturation
Section 7.2.8 Vital Signs.

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PROTOCOL OUTLINE
Study title
A Phase Ib, randomised, double-blind, placebo-controlled study to 
investigate the safety, tolerability, and pharmacokinetics of an intravenous 
monoclonal antibody (mAb) after single ascending doses in subjects affected 
by idiopathic pulmonary fibrosis
Sponsor
Chiesi Farmaceutici S.p.A. - Via Palermo 26/A 43122 Parma - Italy 
Name of the product
CHF10067
Centre(s)
Multi-centre study (approximately 12 sites) 
Indication 
Idiopathic pulmonary fibrosis (IPF)
Study design
Randomised, double-blind, placebo-controlled, single-dose escalation 
Study phase
Phase Ib
Objectives
The primary objective is to assess the safety and tolerability of single 
ascending doses of CHF10067 in subjects with IPF.
The secondary objectives are:

to evaluate the CHF10067 pharmacokinetic (PK) profile in serum 

to evaluate the CHF10067 immunogenicity profile in terms of 
anti-drug antibody (ADA) and neutralising antibody (nAb). 
The exploratory objective is to evaluate transglutaminase 2 (TG2) levels in 
plasma.
Treatment duration
One single dose (CHF10067 or placebo)
Test product 
dose/route/regimen 
A single 1000 mg, anticipated 2000 mg, or anticipated 3000 mg intravenous 
(IV) dose of CHF10067
Reference product 
dose/route/regimen 
A single dose of placebo 
 
Number of subjects
Twenty-four subjects will be studied in 3 cohorts (Cohort A [1000 mg], B 
[anticipated 2000 mg], and C [anticipated 3000 mg]) consisting of 8 subjects 
per cohort. In each cohort, 6 subjects will receive CHF10067, and 2 subjects 
will receive placebo. In each cohort, a minimum of 2 subjects are required 
to be not receiving antifibrotic treatment (including subjects with previous 
use of antifibrotic treatment that has been stopped for at least 2 weeks prior 
to screening).
Study population
Subjects with IPF (not receiving antifibrotic treatment [including subjects 
with previous use of antifibrotic treatment that has been stopped for at least 
2 weeks prior to screening] or receiving standard of care treatments at a 
stable dose for at least 8 weeks prior to screening [nintedanib or 
pirfenidone].
Inclusion/exclusion criteria
Inclusion criteria: 
Subjects must meet all the following inclusion criteria to be eligible for 
enrolment into the study: 

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1.
Subject’s written informed consent obtained prior to any 
study-related procedure.
2.
Males or females, of any race, aged ≥ 40 years of age.
3.
Body mass index between 18.0 and 35.0 kg/m2, inclusive.
4.
Body weight ≥ 45 kg.
5.
Diagnosis of IPF as defined by current American Thoracic 
Society/European 
Respiratory 
Society/Japanese 
Respiratory 
Society/Latin American Thoracic Association guidelines (2022), 
which will include subjects with a usual interstitial pneumonia 
(UIP) pattern or probable UIP pattern with confirmation of IPF 
diagnosis based on the Multi-Disciplinary Team Discussion 
(excluding other possible etiological causes of the high-resolution 
computed tomography [HRCT] pattern). Where a lung biopsy is 
available, the computed tomography (CT) pattern and biopsy 
results must be compatible with a diagnosis of IPF. The diagnosis 
of IPF must be within the past 5 years prior to enrolment, and in the 
opinion of the Investigator, has been stable for at least 3 months.[1]
6.
Subjects not receiving any IPF treatment (including subjects with 
previous use of antifibrotic treatment that has been stopped for at 
least 2 weeks prior to screening) or receiving well-tolerated 
standard of care approved treatments at a stable dose for at least 8 
weeks prior to screening (nintedanib or pirfenidone) and it is 
anticipated the dose will remain unchanged throughout the study.
7.
Oxygen saturation ≥ 92% at rest by pulse oximetry while breathing 
ambient air at screening and prior to randomization.
8.
Forced vital capacity (FVC) ≥ 50% of predicted and ratio of forced 
expiratory volume in the first second (FEV1)/FVC ≥ 0.7 at 
screening.
9.
Diffusing capacity of the lung for carbon monoxide (DLCO; 
corrected for haemoglobin) ≥ 35% at screening.
10. Able to understand the study procedures and the risks involved.
11. Female subjects: 
a.
Women of childbearing potential (WOCBP) fulfilling 1 of 
the following criteria: 
i.
WOCBP with fertile male partners: they and/or 
their partner must be willing to use a highly 
effective birth control method preferably with low 
user dependency from the signature of the 
informed consent and until the last study visit or
ii.
WOCBP 
with 
non-fertile 
male 
partners: 
contraception is not required in this case. 
Or
b.
Female subjects of non-childbearing potential defined as 
physiologically incapable of becoming pregnant (i.e., 
post-menopausal or permanently sterile). Tubal ligation or 
partial surgical interventions are not acceptable. If 

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indicated, as per Investigator’s request, post-menopausal 
status may be confirmed by screening serum follicle-
stimulating hormone levels (according to local laboratory 
ranges). 
12.  Males fulfilling one of the following criteria: 
a.
Males with pregnant or non-pregnant WOCBP partners: 
they must be willing to use male condom from the 
signature of the informed consent and until the last study 
visit or 
b.
Non-fertile male subjects: contraception is not required in 
this case or
c.
Males with partner not of childbearing potential: 
contraception is not required in this case.
For the definition of WOCBP, fertile men, and the list of highly effective 
birth control methods with low user dependency see APPENDIX 3 or Section 
4.1 of the Clinical Trial Facilitation Group guidance.[16] 
The following inclusion criteria should be re-checked at the Day 1 visit (prior 
to randomisation): 7.
Exclusion criteria: 
The presence of any of the following will exclude a subject from study 
enrolment: 
1.
History of lower respiratory tract infection within 4 weeks prior to 
screening and up to Day 1 of the study, which required the use of 
antibiotics and admission to a clinical facility, or community treated 
lower respiratory tract infection that in the opinion of the 
investigator would preclude the subject’s participation in the study.
2.
History of acute exacerbation of IPF within 3 months prior to 
screening and up to Day 1 of the study, defined as:
a.
worsening or newly developed dyspnoea as reported by the 
subject (≤ 30 days)
b.
new 
bilateral 
ground-glass 
opacities 
on 
HRCT 
superimposed on the UIP abnormalities that defined 
subject eligibility for the study, and
c.
worsening 
hypoxemia 
(in 
the 
judgment 
of 
the 
Investigator), in the absence of pulmonary infection, heart 
failure, or other identifiable causes for this finding.
3.
Planned surgery during the study.
4.
Active diagnosis of lung cancer or a history of lung cancer.
5.
Active cancer or a history of cancer (other than lung cancer) with 
less than 5 years disease free survival time (whether or not there is 
evidence of local recurrence or metastases). Localised carcinoma 
(e.g., basal cell carcinoma or in situ carcinoma of the cervix 
adequately treated, etc.) is acceptable. 

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6.
Infiltrative lung disease other than IPF, including any of the 
following:
a.
Other types of idiopathic interstitial pneumonia
b.
Interstitial lung diseases related to exposure to fibrogenic 
agents, other environmental toxins, or drugs
c.
Other types of occupational lung diseases
d.
Granulomatous lung diseases
e.
Pulmonary vascular diseases
f.
Related to systemic diseases (including vasculitis and 
connective tissue diseases).
7.
History of other types of respiratory diseases in the opinion of the 
Investigator, would impact the endpoints in the protocol or 
otherwise preclude the subject’s participation in the study including 
diseases or disorders of the airways, lung parenchyma, pleural 
space, mediastinum, diaphragm, or chest wall.
8.
End-stage fibrotic disease expected to require organ transplantation 
within 6 months.
9.
Trauma or surgical procedures requiring hospitalisation within 
4 weeks prior to screening visit.
10. Subjects exhibiting unhealed wounds or foot ulcers or have known 
history of wound healing complications. 
11. Clinically 
relevant 
and 
uncontrolled 
cardiac, 
hepatic, 
gastrointestinal, renal, endocrine, metabolic, neurologic, or 
psychiatric disorders that may interfere with successful completion 
of this protocol according to the Investigator's judgment.
12. Any abnormal and clinically significant 12-lead electrocardiogram 
(ECG) that in the Investigator's opinion would affect safety 
evaluation or place the subjects at risk at screening and prior to 
randomization. 
13. Chronic heart failure categorized as New York Heart Association 
Class II, III, or IV (this applies to symptoms of chronic heart failure, 
not IPF); clinical diagnosis of cor pulmonale requiring specific 
treatment; or severe pulmonary hypertension requiring specific 
treatment that, in the opinion of the Investigator, would preclude 
the subject’s participation in the study.
14. Currently receiving, or have received, a systemic corticosteroid, 
immunosuppressant, cytotoxic therapy, vasodilator therapy for 
pulmonary hypertension, or unapproved or investigational 
treatment for IPF within 4 weeks prior to screening or prior to 
randomization. Treatment with pirfenidone or nintedanib, though 
not both concurrently, is permitted, provided that the subject has 
been on a well-tolerated stable dose for at least 8 weeks prior to 
screening and it is anticipated the dose will remain unchanged 
throughout the study.
15. Participation in another clinical study with an investigational drug 
in the 1 month or 5 half-lives of that investigational drug 

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(whichever is longer) preceding dosing; a longer and more 
appropriate time could be considered by the Investigator based on 
the elimination half-life and/or long-term toxicity of the previous 
investigational drug.
16. Received the coronavirus disease-2019 (COVID-19) vaccine 
≤ 7 days before dosing.  Any systemic symptoms (e.g., myalgia, 
fever, chills, fatigue, etc.) after COVID-19 vaccine should subside 
at least 2 days before the Day 1 visit.
17. Any other drugs which may interfere with the safe completion of 
the study, according to the Investigator opinion, are also forbidden. 
18. Presence of any current infection, or previous infection that 
resolved less than 7 days prior to screening or before treatment 
(with the exception of lower respiratory tract infections, for which 
the exclusion criterion is defined separately: exclusion criterion n. 
1). 
19. Documented COVID-19 diagnosis within the last 4 weeks or which 
has not resolved within 7 days prior to screening or before 
treatment. COVID-19 testing prior to enrolment and during the 
study will be conducted according to current local guidelines and is 
not specified in the protocol.
20. Known intolerance and/or hypersensitivity to any of the excipients 
contained in the formulation or any other substance used in the 
study.
21. History of allergic or anaphylactic reaction to human, humanised, 
chimeric, 
immunoglobulins 
(Igs), 
or 
murine 
monoclonal 
antibodies.
22. History of severe episodes of urticaria and angioedema or diagnosis 
of chronic urticaria and its underlying disorders including, but not 
limited to acquired angioedema due to C1-inhibitor deficiency, 
auto-inflammatory disease, hereditary angioedema, or urticarial 
vasculitis.
23. Confirmed or suspected diagnosis of mastocytosis.
24. Clinically relevant abnormal laboratory values (clinical chemistry 
and haematology) at screening suggesting an unknown disease and 
requiring further clinical investigation or which may impact the 
safety of the subject or the evaluation of the study results according 
to Investigator judgement. Note: in case of abnormal laboratory 
values, that could indicate a temporary condition, the test can be 
repeated twice before randomisation.
25. Positive human immunodeficiency virus (HIV) 1 and/or HIV2 
results at screening.
26. Positive hepatitis result that indicates acute or chronic hepatitis B 
(HB) or hepatitis C (HC) at screening (i.e., positive HB surface 
antigen, HB core antibody [IgM anti-HB core antibody], or HC 
antibody).

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27. Blood donation or blood loss (equal or more than 450 mL) within 
2 months prior to screening or prior to randomization.
28. History of cigarette (or e-cigarette) smoking or use of nicotine- or 
tobacco-containing products within 3 months prior to screening or 
a positive urine test for cotinine at screening. 
29. Documented history of alcohol abuse within 12 months prior to 
screening or a positive alcohol breath test prior to randomization. 
Note: before randomization, the test can be repeated once, at least 
3 days after the last positive test, if the Investigator evaluates that 
the subject will be compliant to alcohol abstinence during the study.
30. Documented history of drug abuse within 12 months prior to 
screening or a positive urine drug screen prior to randomization. 
Note: before randomization, the test can be repeated once at least 
15 days after the last positive test, if the Investigator evaluates that 
the subject will be compliant to drug abstinence during the study.
31. Unsuitable veins for repeated venipuncture. 
32. Pregnant or lactating women, where pregnancy is defined as the 
state of a female after conception and until termination of the 
gestation, confirmed by a positive serum human chorionic 
gonadotropin laboratory test. A serum pregnancy test will be 
performed at screening and urine pregnancy test will be performed 
prior to randomisation.
The following exclusion criteria should be re-checked at the Day 1 visit 
(prior to randomisation): 1, 2, 12, 14, 18, 19, 27, and 32. 
Study plan
The screening visit will take place between 3 to 28 days prior to 
randomisation and subject eligibility will be assessed according to the 
inclusion/exclusion criteria. 
On Day 1, subjects will attend the clinical site for an ambulatory visit. 
Following confirmation of eligibility, subjects will be randomised to either 
CHF10067 or placebo and will receive a single IV dose of CHF10067 or 
placebo. Subjects will be monitored for safety, tolerability, immunogenicity, 
PK, and TG2 levels for 84 days post-dose and will attend ambulatory visits 
on Days 2, 5, 7, 14, 28, 56, and 84 (end of study). Even if not mandatory, 
overnight stay is always possible for logistical reasons or to accomplish 
site/subject preferences.
In each cohort, subjects will be divided into 2 sub-groups, with each 
sub-group being dosed at least 24 hours apart. The first sub-group will 
comprise 2 subjects (1 CHF10067; 1 placebo). The second sub-group will 
comprise 6 subjects (5 CHF10067; 1 placebo). The decision to dose the 
remaining 6 subjects will be evaluated by at least the Medical Monitor and 
Sponsor Clinical Research Physician based on the safety data provided by 
the Investigator(s) where the first sub-group have been dosed and the 
decision to escalate to the next dose will be made by the Safety Advisory 
Committee. 

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Most relevant allowed 
concomitant treatments
Well-tolerated standard of care treatment of IPF (e.g., nintedanib, 
pirfenidone) at stable doses for at least 8 weeks prior to screening and not 
expected to change during the study. Concomitant intake of nintedanib and 
pirfenidone is not allowed.
COVID-19 vaccine at least 7 days before dosing. Note: Any systemic 
symptoms (e.g., myalgia, fever, chills, fatigue, etc.) after COVID-19 
vaccine should subside at least 2 days before the treatment visit.
Hormone replacement therapy, oral, implantable, transdermal, injectable, or 
intravaginal contraceptives. 
Most relevant forbidden 
concomitant treatments
Systemic corticosteroids, immunosuppressants, cytotoxic therapy or 
vasodilator therapy for pulmonary hypertension, or any other unapproved or 
investigational treatment for IPF. 
In case of exacerbations, appropriate medications can be initiated at 
Investigator’s discretion. 
Any other drug which may interfere with the safe completion of the study, 
according to the Investigator's opinion, is also forbidden.
Safety and immunogenicity 
variables

Adverse events (AEs) and adverse drug reactions

Vital signs (systolic and diastolic blood pressure, pulse rate, 
respiratory rate, and body temperature)

Oxygen saturation measured via pulse oximetry

12-lead ECGs (heart rate, PR, QRS, and QT corrected for heart rate 
by Fridericia's formula)

Physical examinations

Clinical laboratory evaluations: clinical chemistry (including fasting 
glucose) and haematology

Spirometry (FEV1, FVC, FEV1 % of predicted normal and lower limit 
of normal value, FVC % of predicted normal and lower limit of 
normal value, and FEV1/FVC ratio)

Diffusing capacity (DLCO [unadjusted], DLCO % predicted, DLCO 
corrected for haemoglobin, DLCO corrected for haemoglobin % 
predicted, carbon monoxide transfer coefficient, and alveolar volume)

ADAs and nAb

Analysis of systemic markers* of immediate hypersensitivity reaction 
pre-dose and post-dose (post-dose only if required): 
-
Markers of cytokine release syndrome (interferon-γ, tumour 
necrosis factor-α, interleukin [IL]-1 β, IL-2, IL-4, IL-6, IL-8, IL-10, 
IL-12 (p70), and IL-13)
-
Mast cell tryptase 
-
Complement markers (C3a, C5a, CH50, and SC5b-9)
-
CHF10067 IgE
*During the study, the markers analysed may be adjusted as required. Any 
adjustment will be with consideration for subject safety and operational 
activities. 

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Pharmacokinetic variables

Area under the concentration-time curve (AUC) from 0 to the last 
quantifiable concentration (AUC0-t)

AUC extrapolated to infinity (AUCinf)

Maximum observed concentration (Cmax)

Time to Cmax (tmax)

Concentration at steady state of infusion (Cinf)

Clearance (CL)

Volume of distribution (Vz)

Terminal half-life (t1/2).
Other variables

TG2 level in plasma
Sample size calculation
This study is designed to explore the safety and tolerability of CHF10067 
for the first time in subjects affected by IPF, while exposing a minimum 
number of subjects; therefore, no formal power calculation was performed. 
A sample size of 24 subjects (8 subjects per cohort; 6 treated with 
CHF10067 and 2 with placebo) is deemed adequate to assess safety and 
tolerability of CHF10067. In each cohort, a minimum of 2 subjects are 
required to be not receiving antifibrotic treatment (including subjects with 
previous use of antifibrotic treatment that has been stopped for at least 2 
weeks prior to screening).
Statistical methods
Safety and Immunogenicity
Safety parameters will be listed and summarised with change from baseline 
(where applicable) at each post-dose timepoint using descriptive statistics 
and 95% confidence intervals (CIs; where applicable). Time profile plots 
will also be presented where relevant. 
The number of events and the number and percentage of subjects 
experiencing treatment-emergent AEs will be presented by treatment. 
Pharmacokinetics 
CHF10067 serum AUC0-t, AUCinf, Cmax, tmax, Cinf, CL, Vz, and t1/2 will be 
summarised 
by 
dose 
level 
using 
descriptive 
statistics. 
Serum 
concentration/time curves will be presented in linear/linear and log/linear 
scale. Plots will be presented by dose level, based on arithmetic means, and 
by subject, by showing the individual curves grouped by dose level (1 plot 
for each dose level) and ADA positivity/negativity (using different colours).
Dose proportionality in terms of CHF10067 AUC0-t, AUCinf, and Cmax will 
be evaluated using the power model including the log-transformed PK 
parameters as dependent variables, and the log-transformed CHF10067 dose 
as a covariate. The slope for log-transformed dose will be estimated with its 
90% CI to examine dose proportionality.
Other
At each post-dose timepoint, TG2 levels in plasma will be summarised using 
descriptive statistics by treatment as absolute value and change from 
baseline using descriptive statistics and 95% CIs. Time profile plots and 
boxplots will also be presented.

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
ADA
anti-drug antibody
ADL
Activities of Daily Living
ADR
adverse drug reaction
AE
adverse event
ALAT
Latin American Thoracic Society
ATS
American Thoracic Society
AUC
area under the concentration-time curve
AUC0-t
area under the concentration-time curve from 0 to the last quantifiable 
concentration
AUCinf
area under the concentration-time curve extrapolated to infinity
BMI
body mass index
CI
confidence interval
Cinf
concentration at steady state of infusion
CL
clearance
Cmax
maximum observed concentration
COVID-19
coronavirus disease-2019
CTCAE
Common Terminology criteria for Adverse Events
CV
coefficient of variation
DLCO
diffusing capacity of the lung for carbon monoxide
EC
Ethics Committee
ECG
electrocardiogram
eCRF
electronic case report form
ERS
European Respiratory Society 
FEV1
forced expiratory volume in the first second
FSH
follicle-stimulating hormone
FVC
forced vital capacity
GCP
Good Clinical Practice
GMP
Good Manufacturing Practice
HB
hepatitis B
HC
hepatitis C
HIV
human immunodeficiency virus
HRCT
high-resolution computed tomography
IB
Investigator’s Brochure
ICF
informed consent form
ICH
International Council on Harmonisation
IFN-γ
interferon-γ
Ig
immunoglobulin
IL
interleukin
ILD
interstitial lung disease
IMP
investigational medicinal product
IPF
idiopathic pulmonary fibrosis
IRT
interactive responsive technology
IV
intravenous
JRS
Japanese Respiratory Society
KCO
carbon monoxide transfer coefficient
KO
knockout

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mAb
monoclonal antibody
MedDRA
Medical Dictionary for Regulatory Activities
n
number of observed values
nAb
neutralising antibody
PR
PR Interval
PK
pharmacokinetic
QRS 
QRS Interval
QTcF
QT corrected for heart rate by Fridericia’s formula
SAE
serious adverse event
SAP
Statistical Analysis Plan
SC
subcutaneous
SD
standard deviation
SUSAR
Suspected Unexpected Serious Adverse Reaction
t1/2
terminal half-life
TEAE
treatment emergent-adverse events
TG2
transglutaminase 2
tmax
time to maximum observed concentration
TNF-α
tumour necrosis factor-α
UIP
usual interstitial pneumonia
VA
alveolar volume
Vz
volume of distribution
WOCBP
women of childbearing potential

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CONTENT
GENERAL INFORMATION ................................................................................................................................2
VERSION HISTORY.............................................................................................................................................3
PROTOCOL OUTLINE ........................................................................................................................................5
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS......................................................................13
CONTENT.............................................................................................................................................................15
1.
INTRODUCTION.......................................................................................................................................17
1.1 BACKGROUND INFORMATION........................................................................................................................17
1.2 STUDY RATIONALE .......................................................................................................................................18
1.3 RISK/BENEFIT ASSESSMENT..........................................................................................................................18
2.
STUDY OBJECTIVES ...............................................................................................................................19
2.1 PRIMARY OBJECTIVE.....................................................................................................................................19
2.2 SECONDARY OBJECTIVES..............................................................................................................................19
2.3 EXPLORATORY OBJECTIVE............................................................................................................................19
3.
STUDY DESIGN .........................................................................................................................................19
4.
SUBJECT SELECTION CRITERIA........................................................................................................20
4.1 SUBJECT RECRUITMENT ................................................................................................................................20
4.2 INCLUSION CRITERIA.....................................................................................................................................20
4.3 EXCLUSION CRITERIA ...................................................................................................................................22
4.4 SUBJECT WITHDRAWALS ..............................................................................................................................25
5.
CONCOMITANT MEDICATIONS..........................................................................................................26
5.1 PERMITTED CONCOMITANT MEDICATIONS ...................................................................................................26
5.2 NON-PERMITTED CONCOMITANT MEDICATIONS...........................................................................................26
6.
TREATMENT(S) ........................................................................................................................................26
6.1 APPEARANCE AND CONTENT.........................................................................................................................27
6.2 DOSAGE, PREPARATION, AND ADMINISTRATION ..........................................................................................27
6.3 PACKAGING...................................................................................................................................................30
6.4 LABELLING....................................................................................................................................................31
6.5 TREATMENT ALLOCATION ............................................................................................................................31
6.6 TREATMENT CODE ........................................................................................................................................31
6.7 TREATMENT COMPLIANCE ............................................................................................................................32
6.8 DRUG STORAGE.............................................................................................................................................32
6.9 DRUG ACCOUNTABILITY...............................................................................................................................33
6.10 PROVISION OF ADDITIONAL CARE...............................................................................................................33
7.
STUDY PLAN..............................................................................................................................................34
7.1 STUDY SCHEDULE – ALL COHORTS ..............................................................................................................34
7.2 INVESTIGATIONS ...........................................................................................................................................39
8.
PHARMACOKINETIC AND OTHER ASSESSMENTS.......................................................................48
8.1 PHARMACOKINETIC ASSESSMENTS ...............................................................................................................48
8.2 OTHER ASSESSMENTS ...................................................................................................................................49
9.
SAFETY ASSESSMENTS..........................................................................................................................49

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9.1 SAFETY VARIABLES ......................................................................................................................................49
9.2 EMERGENCY SITUATION ...............................................................................................................................50
10.
ADVERSE EVENT REPORTING............................................................................................................51
10.1 DEFINITIONS................................................................................................................................................51
10.2 EXPECTEDNESS ...........................................................................................................................................52
10.3 INTENSITY OF ADVERSE EVENT ..................................................................................................................53
10.4 CAUSALITY ASSESSMENT............................................................................................................................54
10.5 ACTION TAKEN WITH THE STUDY DRUG DUE TO AN ADVERSE EVENT.......................................................54
10.6 OTHER ACTIONS TAKEN..............................................................................................................................54
10.7 OUTCOME....................................................................................................................................................55
10.8 RECORDING ADVERSE EVENTS ...................................................................................................................55
10.9 REPORTING SERIOUS ADVERSE EVENTS TO CHIESI.....................................................................................56
10.10 REPORTING SERIOUS ADVERSE EVENTS TO REGULATORY AUTHORITIES/ETHICS COMMITTEE................56
10.11 GENERAL NOTES.......................................................................................................................................56
11.
DATA MANAGEMENT.............................................................................................................................57
12.
STATISTICAL METHODS.......................................................................................................................58
12.1 SAMPLE SIZE...............................................................................................................................................58
12.2 ANALYSIS SETS...........................................................................................................................................58
12.3 STATISTICAL ANALYSIS ..............................................................................................................................59
13.
ETHICS COMMITTEE .............................................................................................................................63
14.
REGULATORY REQUIREMENTS.........................................................................................................63
15.
INFORMED CONSENT.............................................................................................................................64
16.
SOURCE DOCUMENTS/DATA...............................................................................................................64
16.1 RECORDING OF SOURCE DATA....................................................................................................................64
16.2 DIRECT ACCESS TO SOURCE DOCUMENT/DATA..........................................................................................64
17.
STUDY MONITORING.............................................................................................................................65
18.
QUALITY ASSURANCE...........................................................................................................................65
19.
INSURANCE AND INDEMNITY.............................................................................................................65
20.
CONFIDENTIALITY.................................................................................................................................66
21.
PREMATURE TERMINATION OF THE STUDY ................................................................................66
22.
CLINICAL STUDY REPORT...................................................................................................................66
23.
RECORD RETENTION.............................................................................................................................66
24.
PUBLICATION OF RESULTS.................................................................................................................66
25.
REFERENCES ............................................................................................................................................68
APPENDIX 1 - APPROVAL OF THE PROTOCOL BY COORDINATING CLINICAL 
INVESTIGATOR..................................................................................................................................................71
APPENDIX 2 - APPROVAL OF THE PROTOCOL BY CLINICAL INVESTIGATOR(S).......................72
APPENDIX 3 - RECOMMENDATIONS RELATED TO CONTRACEPTION AND PREGNANCY 
TESTING IN CLINICAL STUDIES ..................................................................................................................73

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2.
STUDY OBJECTIVES
2.1 Primary Objective
The primary objective is to assess the safety and tolerability of single ascending doses of 
CHF10067 in subjects with IPF.
2.2 Secondary Objectives
The secondary objectives are:
to evaluate the CHF10067 PK profile in serum 
to evaluate the CHF10067 immunogenicity profile in terms of ADA and neutralising 
antibody (nAb). 
2.3 Exploratory Objective
The exploratory objective is to evaluate TG2 levels in plasma.
3.
STUDY DESIGN 
This is a Phase Ib, multi-centre, multi-country, randomised, double-blind, placebo-controlled 
study to investigate the safety, tolerability, immunogenicity, and PK of single IV doses of 
CHF10067 in subjects with IPF. The effect of CHF10067 on TG2 levels will also be 
investigated as an exploratory endpoint.
Overall, 24 subjects will be studied in 3 cohorts (Cohorts A [1000 mg], B [anticipated 
2000 mg], and C [anticipated 3000 mg]) consisting of 8 subjects per cohort. In each cohort, 
6 subjects will receive CHF10067, and 2 subjects will receive placebo.
The doses will be administered according to an escalation scheme designed to ensure sufficient 
safety conditions for subjects. In each cohort, subjects will be divided into 2 sub-groups, with 
each sub-group being dosed at least 24 hours apart. The first sub-group will comprise 2 subjects, 
with 1 subject receiving CHF10067 and 1 subject receiving placebo. The second sub-group will 
comprise 6 subjects, with 5 subjects receiving CHF10067 and 1 subject receiving placebo. 
Continuation to dose the remaining 6 subjects will be evaluated by at least the Medical Monitor 
and Sponsor Clinical Research Physician based on the safety data provided by the 
Investigator(s) where the first-sub-group have been dosed. The decision to escalate to the next 
dose will be made by the Safety Advisory Committee when safety data until Day 14 have been 
collected for all subjects at the previous dose level. Pharmacokinetic and immunogenicity data 
will also be included in the safety evaluation for dose escalation (if available) but are not 
mandatory to escalate to the next dose. Further details regarding dose escalation are provided 
in Section 6.2.2.1.
The screening visit will take place between 3 to 28 days prior to randomisation and subject 
eligibility will be assessed according to the inclusion/exclusion criteria. The signed informed 
consent form (ICF) will be obtained prior to any study-related procedures. 

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On Day 1, subjects will attend the clinical site for an ambulatory visit. Following confirmation 
of eligibility, subjects will be randomised to either CHF10067 or placebo and will receive a 
single IV dose of CHF10067 or placebo. 
Subjects will be monitored for safety, tolerability, immunogenicity, PK, and TG2 levels for 
84 days post-dose and will attend ambulatory visits on Days 2, 5, 7, 14, 28, 56, and 84 (end of 
study). The total duration of participation is expected to last approximately 16 weeks. The end 
of the study is defined as the last visit of the last subject in the study. Even if not mandatory, 
overnight stay is always possible for logistical reasons or to accomplish site/subject preferences.
An overview of the study design is shown in Figure 1. 
Figure 1: Study Design
4.
SUBJECT SELECTION CRITERIA
4.1 Subject Recruitment
Overall, 24 subjects will be studied in 3 cohorts (Cohorts A, B, and C), consisting of 8 subjects 
per cohort. In each cohort, 6 subjects will receive CHF10067, and 2 subjects will receive 
placebo. In each cohort, a minimum of 2 subjects are required to be not receiving antifibrotic 
treatment (including subjects with previous use of antifibrotic treatment that has been stopped 
for at least 2 weeks prior to screening).
4.2 Inclusion Criteria 
Subjects must meet all the following inclusion criteria to be eligible for enrolment into the 
study: 
1.
Subject’s written informed consent obtained prior to any study-related procedure.
2.
Males or females, of any race, aged ≥ 40 years of age.
3.
Body mass index (BMI) between 18.0 and 35.0 kg/m2, inclusive.
4.
Body weight ≥ 45 kg.

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5.
Diagnosis of IPF as defined by current ATS/ERS/JRS/ALAT guidelines (2022) which 
will include patients with an usual interstitial pneumonia (UIP) pattern or probable UIP 
pattern with confirmation of IPF diagnosis based on the Multi-Disciplinary Team 
Discussion (excluding other possible etiological causes of the high-resolution 
computed tomography [HRCT] pattern). Where a lung biopsy is available, the 
computerized tomography (CT) pattern and biopsy results must be compatible with a 
diagnosis of IPF.[1]
Diagnosis of IPF must be within the past 5 years prior to enrolment, and in the opinion 
of the Investigator, has been stable for at least 3 months.
6.
Subjects not receiving any IPF treatment (including subjects with previous use of 
antifibrotic treatment that has been stopped for at least 2 weeks prior to screening) or 
receiving well-tolerated standard of care approved treatments at a stable dose for at 
least 8 weeks prior to screening (nintedanib or pirfenidone) and it is anticipated the 
dose will remain unchanged throughout the study.
7.
Oxygen saturation ≥ 92% at rest by pulse oximetry while breathing ambient air at 
screening and prior to randomization.
8.
Forced vital capacity (FVC) ≥ 50% of predicted and ratio of forced expiratory volume 
in the first second (FEV1)/FVC ≥ 0.7 at screening.
9.
Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) 
≥ 35% at screening.
10. Able to understand the study procedures and the risks involved.
11. Female subjects: 
a.
Women of childbearing potential (WOCBP) fulfilling 1 of the following 
criteria: 
i. WOCBP with fertile male partners: they and/or their partner must be 
willing to use a highly effective birth control method preferably with 
low user dependency from the signature of the informed consent and 
until the last study visit or
ii. WOCBP with non-fertile male partners: contraception is not required 
in this case. 
Or
b. Female subjects of non-childbearing potential defined as physiologically 
incapable of becoming pregnant (i.e., post-menopausal or permanently sterile, 
as per definitions given in APPENDIX 3). Tubal ligation or partial surgical 
interventions are not acceptable. If indicated, as per Investigator’s request, 
post-menopausal status may be confirmed by screening serum follicle-
stimulating hormone levels (according to local laboratory ranges). 
12.  Males fulfilling one of the following criteria: 

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a.
Males with pregnant or non-pregnant WOCBP partners: they must be willing 
to use male condom from the signature of the informed consent and until the 
last study visit or 
b. Non-fertile male subjects: contraception is not required in this case or
c.
Males with partner not of childbearing potential: contraception is not required 
in this case.
For the definition of WOCBP, fertile men, and the list of highly effective birth control methods 
with low user dependency see APPENDIX 3 or Section 4.1 of the Clinical Trial Facilitation 
Group guidance [16]. 
The following inclusion criteria should be re-checked at the Day 1 visit (prior to randomisation): 
7.
4.3 Exclusion Criteria
The presence of any of the following will exclude a subject from study enrolment: 
1.
History of lower respiratory tract infection within 4 weeks prior to screening and up to 
Day 1 of the study, which required the use of antibiotics and admission to a clinical 
facility, or community treated lower respiratory tract infection that in the opinion of 
the investigator would preclude the subject’s participation in the study.
2.
History of acute exacerbation of IPF within 3 months prior to screening and up to Day 1 
of the study, defined as:
a.
worsening or newly developed dyspnoea as reported by the subject (≤ 30 days)
b. new bilateral ground-glass opacities on HRCT superimposed on the UIP 
abnormalities that defined subject eligibility for the study, and
c.
worsening hypoxemia (in the judgment of the Investigator), in the absence of 
pulmonary infection, heart failure, or other identifiable causes for this finding.
3.
Planned surgery during the study.
4.
Active diagnosis of lung cancer or a history of lung cancer.
5.
Active cancer or a history of cancer (other than lung cancer) with less than 5 years 
disease free survival time (whether or not there is evidence of local recurrence or 
metastases). Localised carcinoma (e.g., basal cell carcinoma or in situ carcinoma of the 
cervix adequately treated, etc.) is acceptable. 
6.
Infiltrative lung disease other than IPF, including any of the following:
a.
Other types of idiopathic interstitial pneumonias [17] 
b. Interstitial lung diseases related to exposure to fibrogenic agents, other 
environmental toxins, or drugs
c.
Other types of occupational lung diseases

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d. Granulomatous lung diseases
e.
Pulmonary vascular diseases
f.
Related to systemic diseases (including vasculitis and connective tissue 
diseases).
7.
History of other types of respiratory diseases in the opinion of the Investigator, would 
impact the endpoints in the protocol or otherwise preclude the subject’s participation 
in the study including diseases or disorders of the airways, lung parenchyma, pleural 
space, mediastinum, diaphragm, or chest wall.
8.
End-stage fibrotic disease expected to require organ transplantation within 6 months.
9.
Trauma or surgical procedures requiring hospitalisation within 4 weeks prior to 
screening visit.
10. Subjects exhibiting unhealed wounds or foot ulcers or have known history of wound 
healing complications. 
11. Clinically relevant and uncontrolled cardiac, hepatic, gastrointestinal, renal, endocrine, 
metabolic, neurologic, or psychiatric disorders that may interfere with successful 
completion of this protocol according to the Investigator's judgment.
12. Any abnormal and clinically significant 12-lead electrocardiogram (ECG) that in the 
Investigator's opinion would affect safety evaluation or place the subjects at risk at 
screening and prior to randomization. 
13. Chronic heart failure categorized as New York Heart Association Class II, III, or IV 
(this applies to symptoms of chronic heart failure, not IPF); clinical diagnosis of cor 
pulmonale requiring specific treatment; or severe pulmonary hypertension requiring 
specific treatment that, in the opinion of the Investigator, would preclude the subject’s 
participation in the study.
14. Currently receiving, or have received, a systemic corticosteroid, immunosuppressant, 
cytotoxic therapy, vasodilator therapy for pulmonary hypertension, or unapproved or 
investigational treatment for IPF within 4 weeks prior to screening or prior to 
randomization. Treatment with pirfenidone or nintedanib, though not both 
concurrently, is permitted, provided that the subject has been on a well-tolerated stable 
dose for at least 8 weeks prior to screening and it is anticipated the dose will remain 
unchanged throughout the study.
15. Participation in another clinical study with an investigational drug in the 1 month or 
5 half-lives of that investigational drug (whichever is longer) preceding dosing; a 
longer and more appropriate time could be considered by the Investigator based on the 
elimination half-life and/or long-term toxicity of the previous investigational drug.
16. Received the coronavirus disease-2019 (COVID-19) vaccine ≤ 7 days before dosing. 
 Any systemic symptoms (e.g., myalgia, fever, chills, fatigue, etc.) after COVID-19 
vaccine should subside at least 2 days before the Day 1 visit.
17. Any other drugs which may interfere with the safe completion of the study, according 
to the Investigator opinion, are also forbidden. 

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18. Presence of any current infection, or previous infection that resolved less than 7 days 
prior to screening or before treatment (with the exception of lower respiratory tract 
infections, for which the exclusion criterion is defined separately: exclusion criterion 
n. 1).
19. Documented coronavirus disease-2019 (COVID-19) diagnosis within the last 4 weeks 
or which has not resolved within 7 days prior to screening or before treatment. COVID-
19 testing prior to enrolment and during the study will be conducted according to 
current local guidelines and is not specified in the protocol. 
20. Known intolerance and/or hypersensitivity to any of the excipients contained in the 
formulation or any other substance used in the study.
21. History of allergic or anaphylactic reaction to human, humanised, chimeric, Igs, or 
murine monoclonal antibodies.
22. History of severe episodes of urticaria and angioedema or diagnosis of chronic urticaria 
and its underlying disorders including, but not limited to acquired angioedema due to 
C1-inhibitor deficiency, auto-inflammatory disease, hereditary angioedema, or 
urticarial vasculitis.
23. Confirmed or suspected diagnosis of mastocytosis.
24. Clinically relevant abnormal laboratory values (clinical chemistry and haematology) 
at screening suggesting an unknown disease and requiring further clinical investigation 
or which may impact the safety of the subject or the evaluation of the study results 
according to Investigator judgement. Note: in case of abnormal laboratory values, that 
could indicate a temporary condition, the test can be repeated twice before 
randomisation.
25. Positive human immunodeficiency virus (HIV) 1 and/or HIV2 results at screening.
26. Positive hepatitis result that indicates acute or chronic hepatitis B (HB) or hepatitis C 
(HC) at screening (i.e., positive HB surface antigen, HB core antibody [IgM anti-HB 
core antibody], or HC antibody).
27. Blood donation or blood loss (equal or more than 450 mL) within 2 months prior to 
screening or prior to randomization.
28. History of cigarette (or e-cigarette) smoking or use of nicotine- or tobacco-containing 
products within 3 months prior to screening or a positive urine test for cotinine at 
screening. 
29. Documented history of alcohol abuse within 12 months prior to screening or a positive 
alcohol breath test prior to randomization. Note: before randomization, the test can be 
repeated once, at least 3 days after the last positive test, if the Investigator evaluates 
that the subject will be compliant to alcohol abstinence during the study.
30. Documented history of drug abuse within 12 months prior to screening or a positive 
urine drug screen prior to randomization. Note: before randomization, the test can be 
repeated once at least 15 days after the last positive test, if the Investigator evaluates 
that the subject will be compliant to drug abstinence during the study.

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31. Unsuitable veins for repeated venipuncture.
32. Pregnant or lactating women, where pregnancy is defined as the state of a female after 
conception and until termination of the gestation, confirmed by a positive serum human 
chorionic gonadotropin laboratory test. A serum pregnancy test will be performed at 
screening and urine pregnancy test will be performed prior to randomisation.
The following exclusion criteria should be re-checked at the Day 1 visit (prior to 
randomisation): 1, 2, 12, 14, 18, 19, 27, and 32. 
Re-testing is possible as explicated in the relative notes of the inclusion/exclusion criteria list.
Screening failure subjects due to the presence of a temporary conditions (e.g., lower respiratory 
tract infections, unhealed wound, etc.) defined in the exclusion criteria list could be re-screened 
only once if the condition is resolved according to Investigator’s opinion. 
Rescreened participants should be assigned a new subject number and the rescreening 
procedure can be done only once.
4.4 Subject Withdrawals
Subjects must be discontinued from the study for any of the following reasons:
An adverse event (AE) occurs that, in the opinion of the Investigator, makes it unsafe for 
the subject to continue in the study. In this case, the appropriate measures will be taken. 
The subject meets the individual stopping criteria.
The subject is lost to follow-up.
The subject withdraws consent.
The subject's safety is affected by violation of inclusion or exclusion criteria or use of 
not-permitted concomitant medication.
The subject, in the opinion of the investigator, is unwilling or unable to adhere to the 
study requirements, i.e., non-compliance.
The Sponsor or the regulatory authorities or the Ethics Committees (ECs), for any reason, 
terminates the entire study, or terminates the study for this study site or this particular 
subject. 
It is understood by all concerned that an excessive rate of withdrawals can render the study 
uninterpretable; therefore, unnecessary withdrawals of subjects should be avoided. However, 
should a subject discontinue the study, all efforts will be made to complete the Early 
Termination procedures and report the observations as thoroughly as possible.
In the event of early termination, if the subject has not withdrawn his/her consent, an Early 
Termination visit should be scheduled to perform the following safety assessments, as described 
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In case of withdrawal, the Investigator must fill in the “Study Termination” page in the 
electronic case report form (eCRF), reporting the main reason for withdrawal. Subjects who 
discontinue will be replaced in order to ensure that at least 8 evaluable subjects in each dose 
level complete the Day 14 study assessments. In case the discontinuation is due to safety reasons 
assessed as related to the study drug, the subject will not be replaced.
If a subject is withdrawn/drops-out of the study after receiving the test treatment, the subject 
study number and corresponding test treatments should not be reassigned to another subject.
5.
CONCOMITANT MEDICATIONS
5.1 Permitted Concomitant Medications
The following concomitant medications are permitted during the study: 
1. Well-tolerated standard of care treatment of IPF (nintedanib or pirfenidone) at stable 
doses for at least 8 weeks prior to screening and not expected to change during the 
study. Concomitant intake of both nintedanib and pirfenidone is not allowed. 
2. COVID-19 vaccine at least 7 days before dosing. Note: Any systemic symptoms (e.g., 
myalgia, fever, chills, fatigue, etc.)  after COVID-19 vaccine should subside at least 2 
days before the treatment visit.
3. Hormone replacement therapy, oral, implantable, transdermal, injectable, or 
intravaginal contraceptives. 
5.2 Non-permitted Concomitant Medications
The following concomitant medications are not permitted during the study: 
1. Systemic corticosteroids 
2. Immunosuppressants
3. Cytotoxic therapy or vasodilator therapy for pulmonary hypertension
4. Any other unapproved or investigational treatment for IPF
5. Any other drug which may interfere with the safe completion of the study, according to 
the Investigator's opinion, is also forbidden.
In case of exacerbations, appropriate medications can be initiated at Investigator’s discretion.
6.
TREATMENT(S)
CHF10067 and placebo (study treatments) will be supplied to the clinical site under the 
responsibility of the Sponsor, who will also provide the Pharmacist/Investigator with 
appropriate certificates of analytical conformity and Qualified Person release. The placebo 
solution 
 will 
be supplied by the Sponsor as described within the investigational medicinal product (IMP) 
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Continuation to dose the remaining 6 subjects will be evaluated by at least the Medical Monitor 
and Sponsor Clinical Research Physician based on the safety data (e.g., AE profile) provided 
by the Investigator(s) where the first sub-group have been dosed. The procedure for 
communication and initiation of dosing the remaining subjects within each cohort will be 
clearly detailed in a separate charter.
The decision to escalate to the next dose will be made by the Safety Advisory Committee when 
safety data until Day 14 have been collected for all subjects at the previous dose level. 
Pharmacokinetic and immunogenicity data will also be included in the safety evaluation for 
dose escalation (if available) but are not mandatory to escalate to the next dose.
The Safety Advisory Committee will comprise at least the Coordinating Investigator, Medical 
Monitor, Sponsor’s representatives (these may also include Key Opinion Leaders), and site 
Investigators identified from some of the enrolling sites. The presence of all site-Investigators 
is not mandatory. This committee will be governed by a separate charter.
A blinded interim safety report, summarising results from all available safety assessments for 
each subject, as specified above, will be sent by the Investigator(s) and appropriately blinded 
PK and immunogenicity data (if available) will be sent by the appropriate parties to the Sponsor 
and Safety Advisory Committee prior to the start of each successive group. Unblinding during 
the interim review may occur in certain situations, if necessary to take an informed decision, 
and will be clearly detailed in a separate charter. 
A Safety Advisory Committee meeting will occur prior to each dose escalation. In particular, 
any clinically significant results will be discussed before dose escalation continues. 
The decision to dose-escalate will be a unanimous decision between the Sponsor, Medical 
Monitor, and the Coordinating Investigator. If either the Sponsor or the Coordinating 
Investigator considers stopping of dose escalation to be appropriate, dose escalation will be 
terminated. 
Study drug will be discontinued in any individual subject that experiences a drug-related serious 
AE (SAE) or any other AE that, in the opinion of the Coordinating Investigator or site 
Investigator, warrants discontinuation of study drug.
Doses will not be further escalated if:
Two or more subjects on active drug* experience a possibly drug-related SAE
Two or more subjects on active drug* experience a severe, possibly drug-related AE 
lasting for > 24 hours duration
Four or more subjects on active drug* experience at least moderate, possibly drug-related 
AE in the same Medical Dictionary for Regulatory Activities (MedDRA) System Organ 
Class of > 24 hours duration

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Despite the above criteria not being met, a pattern of AEs has emerged that leads the 
Investigator and/or Safety Advisory Committee to believe that dose escalation is not 
justifiable on safety grounds. 
* Unblinding is possible to take an informed decision before stopping the dose escalation, as 
detailed in the separate charter.
6.2.2.2 Background medication
Subjects may take permitted concomitant medications allowed by protocol, but these will not 
be provided by the Sponsor. 
6.2.3 Preparation of the study drug
The preparation of the final concentration will be performed in the Laminar Air Flow Bench or 
other sterile dedicated preparation area using aseptic procedures under unblinded conditions.
The components of the IMP 
 and the 
various items of equipment (infusion bags, lines, syringes, needles, etc.) are all provided in an 
internally sterile state, in common with such items in routine clinical use. In keeping with best 
medical practice, the minimum standards that should be applied in the preparation of IMP for 
administration are those that would be used for the preparation of any other medicinal product 
for IV administration, to minimise the possibility of pathogenic contamination of the contents 
and equipment:
Use of new (previously un-used), freshly-opened materials
Use of a “sterile” (no-touch) technique
Preparation and use in a clean, dust-free environment.
In case of any mistakes during the study drug preparation, a new study drug will be prepared 
using new material.
The list of the components for dose preparation (dilution) and dose administration together with 
detailed instructions for the preparation and dilution of CHF10067 and placebo are provided in 
the IMP Pharmacy Manual.
6.2.4 Administration
No fluid or diet restrictions are required prior treatment administration.
Treatment administration must be completed within 10 hours from the removal of the product 
from the fridge. Doses will be administered as follows: 
Cohort A: Single doses of 1000 mg CHF10067 or placebo will be administered as an IV 
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dispense after these dates. The IRT will monitor inventory levels at all sites and manage the 
study treatment re-supply. 
The randomisation list will be provided to the labelling facility and to the PK/immunogenicity 
laboratory but will not be available to subjects, Investigators, or employees of the site involved 
in the management of the study before unblinding of the data (unless in case of emergency) with 
the following exceptions:
Unblinded Site Pharmacist(s) or the designated/authorised representative involved in IMP 
preparation and dispensing and identified in the appropriate delegation log
Unblinded Monitor(s) who review(s) the IMP-related documentation
Unblinded bioanalytical laboratory staff involved in the analysis of PK/immunogenicity 
samples.
The Sponsor’s clinical team will also be blinded during the study as they will not have direct 
access to the randomisation list.
In case of emergency, where the Investigator considers essential to know what treatment the 
subject was taking, unblinding of the treatment code will be done through IRT and the treatment 
group will be disclosed. The IRT will be designed to send a confirmation (by notification email) 
to the site for every transaction performed by the Investigators, including unblinding. The IRT 
will also promptly notify the Sponsor and the Clinical Monitor whenever a treatment code is 
unblinded. The procedure for unblinding before stopping dose escalation will be described in a 
separate charter. 
Users from Chiesi Global Pharmacovigilance will have their own credentials to unblind 
subjects in case of Suspected Unexpected Serious Adverse Reactions (SUSARs) to be reported 
to the competent Regulatory Authorities and ECs/Institutional Review Boards. 
6.7 Treatment Compliance
For each subject, details of study medication intake will be recorded in the eCRF. 
6.8 Drug Storage 
The unblinded Pharmacist at the Investigator’s site will be responsible for the safe storage of 
all medications assigned to this study, in a secure place with restricted access limited to those 
individuals authorised to dispense the treatment and maintained within the appropriate ranges 
of temperature.
All CHF10067 kits will be stored at refrigerated temperatures at 2°C to 8°C. Placebo will be 
stored not above 30°C. The IMP Pharmacy Manual will contain additional information for 
temperature condition before and after the preparation. 
For the study treatments, the maximum cumulated hold time from the removal of product from 
the fridge to the end of infusion is 10 hours. 

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A summary of the holding times to be applied will be detailed in the IMP Pharmacy Manual.
6.9 Drug Accountability
The Pharmacist, or the designated/authorised representative, is responsible for the management 
of all the study treatments to be used for the study. Study treatments should be stored in a 
locked, secure storage facility with access limited to those individuals authorised to dispense 
the study treatments.
An inventory will be maintained by the Pharmacist (or other designated individual), to include 
a signed account of all the study treatments received and dispensed during the study. 
At the conclusion or termination of the study, the Investigator or the Pharmacist shall conduct 
and document a final drug supply (used and unused) inventory. An explanation will be given 
for any discrepancies.
All the study treatments supplied, used or unused, will be returned to the designated distributor 
centre to be destroyed centrally. The return of study treatments will occur only after full 
accountability and reconciliation are completed. The study treatments destruction will not occur 
until authorised by Chiesi.
6.10 Provision of Additional Care
At completion of subject’s study participation, it is under the Investigator’s responsibility to 
prescribe the more appropriate treatment for the subject or to restore the initial therapy or to 
refer to the General Practitioner.

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7.
STUDY PLAN
7.1 Study Schedule – All Cohorts
Treatment Period
Early 
Termination
Screening 
(Days -28 
to -3)
Day 1
Day 2
Days 5 
and 7 (± 
1 day)
Days 14, 
28, and 56 
(± 2 days)
Day 84 
(± 2 
days)
Informed consent
X
Randomisation
X
Ambulatory visit
X
X
X
X
X
X
X
Treatment Intake
CHF10067 or placebo 
administration a
X
Subject Health Evaluation
In/Ex criteria
X
X b
Medical history
X
Demographic data
X
Height and weight
X
Alcohol breath test
X
Physical examination
X
X
X
X
X
Abbreviated physical 
examination 
X
X
Adverse events recording
X
X
X
X
X
X
X
Restrictions
X
X
X
X
X
X
Concomitant medication
X
X
X
X
X
X
X
Safety Assessment in Blood
Fasting clinical chemistry
X
X
(pre-dose)
X
X h
X
X
X
Haematology
X
X
(pre-dose)
X
X h
X
X
X
Fasting glucose
X
X
(pre-dose)
X
X h
X
X
X
FSH (post-menopausal 
female subjects) and/or 
pregnancy test (females of 
childbearing potential)
X
Serology
X
Markers for evaluation of 
immediate hypersensitivity 
reactions
X f
ADA and nAb (in case of 
positive ADA)
X
(pre-dose)
X
X
X
Other Assessments
TG2 levels
X
(pre-dose)
X
X
Naso-absorption samples
X
(pre-dose)
X i
Proteomic sample (serum)
X
(pre-dose)
X i
Proteomic sample (plasma)
X
(pre-dose)
Optional transcriptomic 
samples
X
(pre-dose)
X i
Assessments in Urine
Urinalysis
X
Drug screen
X

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Treatment Period
Early 
Termination
Screening 
(Days -28 
to -3)
Day 1
Day 2
Days 5 
and 7 (± 
1 day)
Days 14, 
28, and 56 
(± 2 days)
Day 84 
(± 2 
days)
Cotinine
X
Pregnancy test (females of 
childbearing potential)
X
X j
X
Pharmacokinetic in Blood c
CHF10067
X
X
X
X
X
Safety Cardiac Assessments 
Vital signs d
X
X
X
X
X
X
X
Local 12-lead ECG e
X
X
X
X
X
X
X
Safety Pulmonary 
Assessments 
Oxygen saturation g
X
X
X
X
X
X
X
Spirometry
X
X k
X k
X
X
Diffusing capacity
X
X l
X
X
Abbreviations: ADA = anti-drug antibody; ECG = electrocardiogram; FSH = follicle-stimulating hormone; In/Ex = 
inclusion/exclusion; nAb = neutralising antibody; TG2 = transglutaminase 2. 
Footnotes for Evaluation Schedule: 
a Special attention will be given to immediate hypersensitivity reactions and monitoring up to 8 hours post-dose is required. If 
the subject has no symptoms, he/she can be discharged. If the subject has symptoms, he/she may remain overnight. An overnight 
stay is also permitted for logistical reasons and/or site’s/subject’s preference. 
b Specific In/Ex criteria will also be checked pre-dose on Day 1 according to study schedule and In/Ex criteria. 
c Pharmacokinetic blood samples for serum CHF10067 will be collected at the following timepoints: pre-dose (within 
75 minutes from start of infusion), at the end of infusion, and 2, 4, 8, and 20 hours after the end of the infusion and 5, 7, 14, 
28, 56 and 84 days post-dose.
d Vital signs (blood pressure, pulse rate, respiratory rate, body temperature): systolic and diastolic blood pressure will be 
evaluated in duplicate after 5 minutes in supine position. Vital signs will be measured at screening and at the following 
timepoints: pre-dose, every 15 minutes during the infusion (e.g., 15, 30, 45, 60, 75, 90, 105, etc.), at the end of the infusion and 
30 min, 1, 2, 3, 4, 6, 8, and 20 hours after the end of the infusion and 5, 7, 14, 28, 56, and 84 days post-dose.
e Local 12-lead ECG: a triplicate ECG will be performed to assess eligibility and a single ECG will be evaluated at all other 
timepoints. Electrocardiograms will be measured at screening and at the following timepoints: pre-dose on Day 1, and Days 2, 
7, 28, and 84.
f Markers for evaluation of immediate hypersensitivity reactions: pre-dose for all subjects. If required (based on subject 
experiencing symptoms of immediate hypersensitivity reactions), blood samples will be collected at 1 and 2 hours after the 
onset of the event.
g Oxygen saturation: will be measured at screening and continuous monitoring will occur from pre-dose to 10 hours post-
dose at the following timepoints: pre-dose, every 15 minutes during the infusion (e.g., 15, 30, 45, 60, 75, 90, 105, etc.), at 
the end of the infusion and 30 min, 1, 2, 3, 4, 6, 8, hours after the end of infusion. Oxygen saturation will also be measured 
at 20 hours after the end of infusion, and 5, 7, 14, 28, 56 and 84 days post-dose.
h Clinical laboratory evaluations will be conducted on Day 7 only. 
i Sample(s) will be collected on Day 14 only.
j Pregnancy test conducted on Days 28 and 56.
k Spirometry conducted on Days 7, 28, and 56 only. 
l Diffusing capacity conducted on Days 28 and 56 only.
7.1.1 Screening
A screening visit will take place between 3 to 28 days prior to randomisation to identify eligible 
consenting subjects for the study. 

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The signed written INFORMED CONSENT by potential eligible subjects will be collected, 
after the study has been fully explained by the Investigator or designee. The Investigator or 
his/her designee should provide the subjects ample time and opportunity to inquire about details 
of the study and to decide whether or not to participate in the study. If the subject agrees to 
participate, the signed and dated informed consent must be obtained before any below study 
related procedures. If the restrictions and/or the fasting are not respected, the visit should be 
rescheduled. 
The following procedures will take place:
SUBJECT SELECTION: Inclusion/exclusion criteria will be checked. 
MEDICAL/SURGICAL HISTORY AND CONCOMITANT DISEASES: Subject health 
history will be recorded.
DEMOGRAPHY DATA COLLECTION: Demographic data including age, sex, and 
race, will be recorded.
HEIGHT AND WEIGHT: Will be recorded.
ALCOHOL BREATH TEST: Will be performed.
PHYSICAL EXAMINATION: A comprehensive physical examination will be 
performed according to Section 7.2.10.
ADVERSE EVENTS RECORDING: Adverse events occurred since the signature of the 
informed consent will be recorded. In case of any clinically significant abnormality 
revealed during the physical examination or screening procedures, it will be recorded in 
the subject’s medical history, unless its start date/time is after the informed consent 
signature date/time and it is not due to a pre-existing condition. In the latter case, it will 
be recorded as an AE.
STUDY RESTRICTIONS: Study restrictions criteria will be checked according to 
section 7.1.4.
PRIOR AND CONCOMITANT MEDICATIONS CHECK: Any systemic corticosteroid, 
immunosuppressant, cytotoxic therapy, vasodilator therapy for pulmonary hypertension, 
or unapproved or investigational treatment for IPF within 4 weeks prior to screening will 
be recorded.  Any other drug which may interfere with the safe completion of the study 
will also be recorded. Permitted treatment with pirfenidone or nintedanib will also be 
recorded.
BLOOD TESTING: Blood sample collection for safety evaluations (clinical chemistry, 
haematology, serology, fasting glucose), pregnancy (females of childbearing potential), 
and FSH (post-menopausal female subjects) testing according to Sections 7.2.2.1 to 
7.2.2.3. Subjects have to be in fasting condition from at least 10 hours before clinical 
chemistry and fasting glucose samples are collected.
URINE TESTING: Urine sample collection for urinalysis, drug screen and cotinine test 
will occur according to Section 7.2.6.
VITAL SIGNS: Measurement of systolic and diastolic blood pressure, pulse rate, 
respiratory rate, and body temperature according to Section 7.2.8.

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LOCAL ECG: Triplicate 12-lead ECG will be used to measure heart rate, PR, QRS, and 
QT corrected for heart rate by Fridericia's formula (QTcF) according to Section 7.2.9.
PULMONARY ASSESSMENTS: Oxygen saturation, Spirometry (FEV1, FEV1 % of 
predicted normal and lower limit of normal value, FVC, FVC% of predicted normal and 
lower limit of normal value, and FEV1/FVC), , and diffusing capacity (DLCO [unadjusted], 
DLCO % predicted, DLCO corrected for haemoglobin, DLCO corrected for haemoglobin % 
predicted, carbon monoxide transfer coefficient [KCO], and alveolar volume [VA]) will 
be measured according to Section 7.2.7.
7.1.2 Treatment period
The subject will attend ambulatory visits on Days 1, 2, 5, 7, 14, 28, 56, and 84 (end of study).
The following procedures will take place during the treatment period: 
SUBJECT SELECTION (Day 1 visit): Inclusion criteria no. 7 and exclusion criteria no. 
1, 2, 12, 14, 18, 19, 27, and 32 will be re-checked as requested in Sections 4.2 and 4.3. 
Subjects not fulfilling the mentioned criteria will be screen failed. 
RANDOMISATION (Day 1 visit): Subjects will be randomised to receive a single IV 
dose of CHF10067 or placebo. 
DOSING (Day 1 visit): Subjects will be administered a single IV dose of CHF10067 or 
placebo. 
PHYSICAL EXAMINATION (Day 1, 2, 5, and 7 visits): A full physical examination 
will be performed according to Section 7.2.10 and any new revealed clinically significant 
abnormality since the last visit will be recorded as an AE.
ABBREVIATED PHYSICAL EXAMINATION (Day 14, 28, 56, and 84 visits): A 
symptom-directed physical examination will be performed according to Section 7.2.10 
and any new revealed clinically significant abnormality since the last visit will be 
recorded as an AE.
ADVERSE EVENTS RECORDING (all visits): Any new AE/SAE occurred since the 
last visit will be checked and recorded in the eCRF. The status of ongoing AEs will be 
checked and updated in the eCRF when applicable. Moreover, during this period in case 
of any new clinically significant abnormality revealed during the examination or 
procedures, it will be recorded as an AE.
STUDY RESTRICTIONS (all visits): Study restrictions criteria will be checked 
according to section 7.1.4.
CONCOMITANT MEDICATIONS CHECK (all visits): Concomitant medications taken 
by the subject since the last visit will be checked and recorded in the eCRF.
BLOOD TESTING: Blood sample collection for safety evaluations (clinical chemistry, 
haematology, fasting glucose [Day 1 pre-dose, 2, 7, 14, 28, 56, and 84 visits], 
immunogenicity [Day 1 pre-dose, 14, 28, 56, and 84 visits], and markers for evaluation 
of immediate hypersensitivity reactions [Day 1 visit]) according to Sections 7.2.2.1, 

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7.2.2.4 and 7.2.2.5. Subjects have to be in fasting condition from at least 10 hours before 
clinical chemistry and fasting glucose samples are collected.
URINE TESTING: Urine samples for pregnancy testing (females of childbearing 
potential [Day 1, 28, 56, and 84 visits]) will occur according to Section 7.2.6
PHARMACOKINETIC INVESTIGATION (all visits): Collection of blood for PK 
assessment according to Section 7.2.1.
VITAL SIGNS (all visits): Measurement of systolic and diastolic blood pressure, pulse 
rate, respiratory rate, and body temperature according to Section 7.2.8.
LOCAL ECG (Day 1, 2, 7, 28, and 84 visits): Single 12-lead ECG will be used to 
measure heart rate, PR, QRS, and QTcF according to Section 7.2.9.
PULMONARY ASSESSMENTS: Oxygen saturation (all visits), Spirometry (Day 7, 28, 
56, and 84 visits); FEV1, FEV1 % of predicted normal and lower limit of normal value, 
FVC, FVC% of predicted normal and lower limit of normal value, FEV1/FVC, and 
diffusing capacity (Day 28, 56, and 84 visits); DLCO (unadjusted), DLCO % predicted, DLCO 
corrected for haemoglobin, DLCO corrected for haemoglobin % predicted, KCO, and VA) 
will be measured according to Section 7.2.7.
TG-2 ASSESSMENT (Day 1, 14, 28, 56, and 84 visits): Transglutaminase 2 levels in 
plasma will be measured according to Section 7.2.3.
NASO-ABSORPTION SAMPLES (Day 1 and Day 14 visits): Two mucosal samples 
(one from each nostril) will be taken at each timepoint according to Section 7.2.5.
SERUM PROTEOMIC SAMPLE (Day 1 and Day 14 visits): A blood sample for serum 
proteomic analysis will be taken at each timepoint according to Section 7.2.4. 
PLASMA PROTEOMIC SAMPLE (Day 1 visit): A blood sample for plasma proteomic 
analysis will be taken at each timepoint according to Section 7.2.4. 
OPTIONAL TRANSCRIPTOMIC SAMPLES (Day 1 and Day 14 visits): Two blood 
samples for possible whole blood transcriptomic analysis will be taken at each timepoint 
according to Section 7.2.11. 
7.1.3 Early termination
The following procedures will take place at the early termination visit in case of subject 
discontinuation/withdrawal: 
PHYSICAL EXAMINATION: A full physical examination will be performed according 
to Section 7.2.10 and any new revealed clinically significant abnormality since the last 
visit will be recorded as an AE.
ADVERSE EVENTS RECORDING: Any new AE/SAE occurred since the last visit will 
be checked and recorded in the eCRF. The status of ongoing AEs will be checked and 
updated in the eCRF when applicable. Moreover, in case of any new clinically significant 
abnormality revealed during the examination or procedures, it will be recorded as an AE. 
CONCOMITANT MEDICATIONS CHECK: Concomitant medications taken by the 
subject since the last visit will be checked and recorded in the eCRF.

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BLOOD TESTING: Blood sample collection for safety evaluations (clinical chemistry, 
haematology, fasting glucose) and immunogenicity according to Sections 7.2.2.1 and 
7.2.2.4. 
VITAL SIGNS: Measurement of systolic and diastolic blood pressure, pulse rate, 
respiratory rate, and body temperature according to Section 7.2.8.
LOCAL ECG: Single 12-lead ECG will be used to measure heart rate, PR, QRS, and 
QTcF according to Section 7.2.9.
PULMONARY ASSESSMENTS: Oxygen saturation, Spirometry (FEV1, FEV1 % of 
predicted normal and lower limit of normal value, FVC, FVC % of predicted normal and 
lower limit of normal value, and FEV1/FVC), and diffusing capacity (DLCO [unadjusted], 
DLCO % predicted, DLCO corrected for haemoglobin, DLCO corrected for haemoglobin % 
predicted, KCO, and VA) will be measured according to Section 7.2.7.
7.1.4 Study restrictions and standardisation
The following restrictions must be applied and re-checked as appropriate at each visit:
No smoking cigarettes (or e-cigarettes) or nicotine- or tobacco-containing products during 
the treatment period
No strenuous exercise within 24 hours prior to and during each visit
No caffeine-containing foods and beverages within 10 hours prior to and during each visit
No intake of beverages or food containing alcohol within 48 hours prior to and during 
each visit
No intake of food for at least 10 hours prior to collection of clinical chemistry and fasting 
glucose.
If these restrictions are not respected, the visit can be rescheduled once and all the information 
regarding restriction(s) not respected, will be recorded in the eCRF. If the restrictions are again 
not respected, the visit will be performed anyway and all the information regarding restriction 
not respected will be recorded in the eCRF.
7.2 Investigations
In case of coinciding investigations, the timepoint for blood collection for PK evaluation takes 
priority over any other scheduled study activities, e.g., vital signs and oxygen saturation. Where 
other activities are scheduled together with the PK blood collection, these will be performed in 
a sequence allowing for blood sampling exactly at the scheduled timepoint. The exact time of 
each activity will be recorded in the eCRF.
Due to the variability in sampling requirements at different laboratories, the total volume of 
blood collected from each subject may vary. The approximately blood volume to be withdrawn 
per subject will be around 250 mL.

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7.2.1 Blood collection for pharmacokinetic evaluation
7.2.1.1 Sample collection for PK evaluation and sample preparation
The laboratory analysis will be carried out following GCP.
The analytical procedures will be described in a separate analytical protocol. Validation data 
and details of the analytical procedures will be gathered in an analytical report that will be 
included in the Clinical Study Report.
7.2.1.2 Determination of CHF10067
Blood samples (1 sample = 3.5 mL) for determination of serum CHF10067 will be collected at 
the following timepoints: pre-dose (within 75 minutes from start of infusion), at the end of 
infusion, 2, 4, 8, and 20 hours after the end of infusion and 5, 7, 14, 28, 56, and 84 days 
post-dose. The selected timepoints are based on the results obtained after single dose in healthy 
subjects. Timepoints may be adjusted during the study if the PK profile in IPF patients is 
significantly different than healthy subjects. In that case, decisions will be taken by the Safety 
Advisory Committee and appropriately documented. The total number of timepoints is not 
expected to be modified. 
The time deviation window for PK sampling will be:
± 5 minutes for timepoints ≤ 2 hours
± 15 minutes for timepoints > 2 hours and ≤ 8 hours
± 1 hour for the timepoint of 20 hours
± 1 day for Days 5 and 7
± 2 days for Days 14, 28, 56, and 84. 
The processing, storage and shipment of samples are detailed in the Laboratory Manual 
document.
7.2.2 Blood collection for safety evaluation
Blood collection and sample preparation will be performed according to procedures provided 
by the local laboratory and central laboratories (where relevant) which will be in charge to 
transmit the results and the laboratory normal ranges for entry in the eCRF.
7.2.2.1 Clinical laboratory evaluations
The following blood samples will be collected at each visit:
Blood for serum clinical chemistry testing (creatinine, urea, aspartate aminotransferase, 
alanine aminotransferase, gamma-glutamyl transpeptidase, total bilirubin, alkaline 
phosphatase, sodium, potassium, and chlorine), and fasting glucose

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Blood for haematology testing (red blood cells count, white blood cells count and 
differential (neutrophils, eosinophils, lymphocytes, monocytes, basophils; % and values), 
total haemoglobin, haematocrit, and platelets count).
For exclusion criteria no. 24, in case clinically relevant abnormal laboratory values are observed 
at screening that suggest a temporary condition and requiring further clinical investigation, the 
subject will be asked to return to clinic for a maximum of twice before treatment, to perform 
again the testing measurement. If at that time no abnormalities are observed, the subject can be 
included in the study, otherwise the subject will be discharged and recorded as screening failure.
The volume of blood required for these samples may vary between sites. 
7.2.2.2 Serology
The following blood sample will be collected at screening:
Blood for serum serology testing (HIV1, HIV2, Hepatitis B, and Hepatitis C).
The volume of blood required for this sample may vary between sites. 
7.2.2.3 Pregnancy and follicle-stimulating hormone testing 
The following blood samples will be collected at screening:
Blood for pregnancy testing (females of childbearing potential)
Blood for follicle-stimulating hormone testing (post-menopausal subjects only).
The volume of blood required for these samples may vary between sites. 
7.2.2.4 Immunogenicity
The following blood samples will be collected pre-dose and Days 14, 28, 56, and 84:
5 mL of blood for immunogenicity assessments (serum non-isotype ADAs) and nAb (in 
case of ADA positive result). 
The analytical procedures will be described in a separate analytical protocol. Validation data 
and details of the analytical procedures will be gathered in an analytical report that will be 
included in the Clinical Study Report. The processing, storage and shipment of samples are 
detailed in the Laboratory Manual document.
Antibodies to CHF10067 will be evaluated in blood samples collected from all subjects 
according to the study schedule (Section 7.1). Additionally, samples should be collected at the 
early termination visit from subjects who discontinued study drug or were withdrawn from the 
study. These samples will be tested by the Sponsor or Sponsor's designee. 

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Samples will be screened for antibodies binding to CHF10067, and the titer of confirmed 
positive samples will be reported. Other analyses may be performed to further characterise the 
immunogenicity of CHF10067. In particular, positive ADA samples will be also evaluated for 
the presence of IgE CHF10067, to clarify the relationships between this ADA subtype and the 
presence of adverse reactions. 
The detection and characterisation of antibodies to CHF10067 will be performed using a 
validated assay method by or under the supervision of the Sponsor. All samples collected for 
detection of antibodies to study drug will also be evaluated for CHF10067 concentration, to 
enable interpretation of the antibody data. Antibodies may be further characterised and/or 
evaluated for their ability to neutralise the activity of the study drug. Samples may be stored for 
a maximum of 20 years (or according to local regulations) following the last subject’s final visit 
for the study at a facility selected by the Sponsor to enable further analysis of immune responses 
to CHF10067. 
7.2.2.5 Systemic markers of immediate hypersensitivity reactions
Subjects will be monitored up to 8 hours post-dose for immediate hypersensitivity reactions 
and will be discharged if no symptoms are reported. If a subject experiences symptoms of an 
immediate hypersensitivity reactions, they may remain at the clinical site overnight until the 
resolution of symptoms. Refer to Section 7.2.2.5.1 for recording of immediate hypersensitivity 
reactions.
The following blood samples will be collected for analysis of systemic markers* of immediate 
hypersensitivity reactions pre-dose (all subjects) and post-dose (1 and 2 hours after the start of 
reaction only if required). 
-
Serum markers of cytokine release syndrome (interferon-γ [IFN-γ], tumour necrosis 
factor-α [TNF-α], interleukin [IL]-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 [p70], and 
IL-13)
-
Serum mast cell tryptase
-
Complement markers (plasma C3a, plasma C5a, serum CH50, and plasma SC5b-9)
-
Serum CHF10067 IgE 
*During the study, the markers analysed may be adjusted as required; therefore, due to the 
potential variability in blood volume, this has not been specified. Any adjustment will be with 
consideration for subject safety and operational activities. 
7.2.2.5.1 Management and documenting of immediate hypersensitivity reactions
Immediate hypersensitivity reactions are known and anticipated reactions occurring with 
monoclonal antibodies. Standard precautions must be taken for the subjects regarding routine 
IV infusion complications. Appropriate medical management according to local guidelines and 
standard operating procedures should be implemented if an immediate hypersensitivity reaction 
is suspected (e.g., appropriate medical treatment, reducing or stopping the infusion rate, etc.).

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Immediate hypersensitivity reactions [15] should be considered in all cases where any 
symptoms or signs related to the acute/hypersensitivity reactions occur during or within 24 
hours from infusion. All efforts should be made to accurately document symptoms, signs, and 
vital signs to allow accurate characterisation of the reaction. 
In case of occurrence of symptoms and signs indicative of the immediate hypersensitivity 
reactions the Investigator is asked to duly record (but not limited to) the following data: 
Exact time when the reaction started and the duration of the reaction
Oxygen saturation, respiratory rate, blood pressure, and 12-lead ECG 
Signs or symptoms including, but not limited to:
-
cutaneous and SC involvement: generalised erythema, urticaria, periorbital oedema, 
angioedema, pruritis, or flushing 
-
signs of cardiovascular compromise: cyanosis, arrhythmia, collapse, diaphoresis, or 
incontinence
-
nervous system involvement: dizziness, confusion, or loss of consciousness
-
gastrointestinal tract involvement: abdominal pain, vomiting, or nausea
-
respiratory involvement: dyspnoea, wheezing-bronchospasm, stridor, chest, or throat 
tightness.
If any other symptoms/signs, these should be specified. In addition, additional blood samples 
will be collected as described in Section 7.2.2.5. 
The severity grade of the immediate hypersensitivity reactions should be assessed by the 
Investigator, considering the following grading system [18]:
1. Mild (skin and SC tissues only)
a.
Generalised erythema, urticaria, periorbital oedema, or angioedema.
2. Moderate (features suggesting respiratory, cardiovascular, or gastrointestinal tract 
involvement)
a.
Dyspnoea, stridor, wheeze, bronchospasm, chest, or throat tightness
b. Abdominal pain, nausea, or vomiting
c.
Dizziness (presyncope), or diaphoresis.
3. Severe (hypoxia, hypotension, or neurological compromise)
a.
Cyanosis or hypoxemia (oxygen saturation ≤ 92%)
b. Hypotension (systolic blood pressure < 90 mmHg)
c.
Confusion, collapse, loss of consciousness, or incontinence.

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Characterisation of the immediate hypersensitivity reactions will be performed at the end of 
study after all clinical and biochemical data are available and analysed by Safety Advisory 
Committee. 
Anaphylactic reactions, defined as IgE mediated, are not expected to occur during the first 
administration. However, when an anaphylactic reaction is suspected, CHF10067 should be 
discontinued immediately and appropriate therapy as per standard of care including 
epinephrine, diphenhydramine, corticosteroids, oxygen, and volume expansion should be 
administered. 
Clinical criteria to diagnose anaphylaxis are summarised below [19]: 
Anaphylaxis is highly likely when any 1 of the following 3 criteria is fulfilled: 
1. Acute onset of illness (minutes to several hours) with involvement of the skin, 
mucosal tissue, or both (e.g., generalised urticaria, pruritis, flushing, or angioedema)
AND at least 1 of the following
a.
Respiratory compromise (e.g., Dyspnoea, wheeze-bronchospasm, 
stridor, chest tightness, or hypoxemia [oxygen saturation ≤ 92%])
b. Hypotension (blood pressure < 90 mmHg) or associated symptoms of 
end-organ dysfunction (e.g., collapse, syncope, or incontinence).
2. Two or more of the following that occur after exposure (minutes to several hours): 
a.
Involvement of the skin, mucosal tissue, or both (e.g., generalised urticaria, 
pruritis, flushing, or angioedema)
b. Respiratory compromise (e.g., dyspnoea, wheeze-bronchospasm, stridor, 
chest tightness, or hypoxemia [oxygen saturation ≤ 92%])
c.
Hypotension (blood pressure < 90 mmHg) or drop in blood pressure (> 30% 
of subject’s baseline) or associated symptoms of end-organ dysfunction (e.g., 
collapse, syncope, or incontinence)
d. Persistent gastrointestinal symptoms (e.g., abdominal pain, nausea, or 
vomiting).
3. Reduced blood pressure after exposure to a known allergen for that subject (minutes to 
several hours): 
a.
Systolic blood pressure of < 90mmHg 
OR 
b. Drop in systolic blood pressure > 30% decrease from that subject’s baseline.

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Additional precautions should be taken for the next subjects to be treated, such as intake of 
pre-treatment medication or changes in the infusion rate and duration and will be discussed at 
Safety Advisory Committee level and communicated to all the enrolling sites before the next 
dosing. 
7.2.3 Blood collection for transglutaminase 2 evaluation
The following blood samples will be collected pre-dose and on Days 14, 28, 56, and 84:
4 mL of blood for plasma TG2 levels.
Evaluation of TG2 will also include a group of 24 samples obtained from healthy subjects (i.e., 
from a biobank), in order to allow for a comparison of TG2 levels between healthy volunteers 
and IPF patients. The analytical procedures will be described in a separate analytical protocol. 
Validation data and details of the analytical procedures will be gathered in an analytical report 
that will be included in the Clinical Study Report. The processing, storage, and shipment of 
samples are detailed in the Laboratory Manual document.
7.2.4 Blood collection for proteomic analysis
The following blood samples will be collected:
8.5 mL of blood for serum proteomic analysis (pre-dose on Day 1 and on Day 14).
6 mL of blood for plasma proteomic analysis (pre-dose on Day 1). 
The processing, storage and shipment of samples are detailed in the Laboratory Manual 
document. The samples for proteomic analysis will be collected for exploratory purposes and 
will be retained until up to 20 years to be possibly used for post-hoc analysis and investigations. 
Results will not be part of the current statistical analysis and will not be included in the Clinical 
Study Report.
7.2.5 Mucosal sample collection by naso-absorption
Two mucosal samples (1 from each nostril) will be collected pre-dose on Day 1 and on Day 14 
via naso-absorption. Naso-absorption is a non-invasive procedure using a synthetic absorptive 
matrix swab to absorb mucosal lining fluid from the mucosa within the nose. A detailed 
description of the naso-absorption procedure will be outlined in separate documents.
The processing, storage, and shipment of samples are detailed in the laboratory manual 
document. The mucosal samples will be collected for exploratory purposes and will be retained 
until up to 20 years to be possibly used for post-hoc analysis and investigations. Results will 
not be part of the current statistical analysis and will not be included in the Clinical Study 
Report. 
7.2.6 Urine collection for safety evaluation
The following urine sample will be collected at screening:

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Urine sample for urinalysis – quantitative (proteins) and urinalysis – qualitative (ketones, 
microscopic examination of the sediment)
Urine sample for drug test (cannabinoids, opiates, cocaine, benzodiazepines, 
amphetamines, barbiturates)
Urine sample for cotinine test.
The following urine samples will be collected on the Day 1, 28, 56, and 84 visit:
Urine sample for pregnancy test.
Urine collection and sample preparation will be performed according to procedures provided 
by the local laboratory which will be in charge to transmit the results to the Investigator for 
entry in the eCRF.
7.2.7 Pulmonary assessments for safety evaluation
7.2.7.1 Spirometry 
Spirometry will be assessed at the following timepoints: screening, 7, 28, 56, and 84 days post-
dose and in case of early termination visit.
Spirometry will be assessed centrally. The specific procedures for centralized spirometry will 
be provided to the Investigator by the centralized spirometry company. The same brand and 
model of spirometer will be provided by the centralised spirometry company for all 
measurements and adjusted for the ATS/ERS standards [20]. Lung function measurements will 
be done with subjects sitting with the nose clipped after at least 10 minutes rest. Values will be 
corrected for body temperature and pressure (saturated) conditions. 
The following parameters (but not limited to) will be recorded: FEV1, FVC, FEV1% of 
predicted normal and lower limit of normal value, FVC % of predicted normal and lower limit 
of normal value, and FEV1/FVC ratio. 
Predicted values of FEV1 will be calculated according to formulas reported by Quanjer et al. 
[21]. 
For FEV1 and FVC, the highest value from 3 technically satisfactory attempts will be recorded 
in the eCRF (irrespective of the curve they come from). The chosen value should not exceed 
the next one by more than 150 mL. If the difference is larger, up to 8 measurements will be 
made and the largest value be reported. In order to be considered as technically satisfactory 
attempts, measurements should be free from cough and false-start and meet all the ERS/ATS 
criteria. The FEV1/FVC should be taken from the highest FEV1 and FVC values (even if not 
coming from the same curve). The acceptability criteria for spirometry assessment will be 
further specified in separate documents. 
For inclusion criterion no. 8 if the criterion is not met at screening, the subject may repeat the 
tests. If at that time the values fall within the ranges specified, the subject can be included in 
the study, otherwise the subject will be discharged and recorded as screening failure. 

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7.2.7.2 Diffusing capacity 
Diffusing capacity will be assessed at the following timepoints: screening, 28, 56, and 84 days 
post-dose and in case of early termination visit. 
Diffusing capacity will be assessed locally using the device available at each site. The devices 
used should be in accordance with current requirements issued by ERS/ATS in 2017 [22]. The 
test will be performed with subjects in a sitting position and nose clipped. Subjects should avoid 
exercise and cigarette smoking on the day of the test. All the results will be uploaded to a central 
database and will be evaluated centrally. 
The following parameters (but not limited to) will be reported: DLCO (unadjusted), DLCO % 
predicted, DLCO corrected for haemoglobin, DLCO corrected for haemoglobin % predicted, KCO, 
and VA.
The reported DLCO will be corrected for the current haemoglobin level, using reference 
equations.
For inclusion criterion no.9, if the criterion is not met at screening, the subject will repeat the 
test. If at that time the values fall within the ranges specified, the subject can be included in the 
study; otherwise, the subject will be discharged and recorded as screening failure.
7.2.7.3 Oxygen saturation
Oxygen saturation will be measured by continuous pulse oximetry at screening and from pre-
dose to 10 hours post-dose at the following timepoints: pre-dose, every 15 minutes during the 
infusion (e.g., 15, 30, 45, 60, 75, 90, 105, etc.), at the end of infusion and 30 min, 1, 2, 3, 4, 6, 
8 hours after the end of the infusion. Oxygen saturation will also be measured at 20 hours after 
the end of the infusion, and 5, 7, 14, 28, 56, and 84 days post-dose and in case of early 
termination visit.
For inclusion criterion no.7, if the criterion is not met at screening or at the Day 1 visit, the 
subject will repeat the test. If at that time the values fall within the ranges specified, the subject 
can be included in the study, otherwise the subject will be discharged and recorded as screening 
failure.
7.2.8 Vital signs
Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, and body 
temperature) will be evaluated at the following timepoints: screening, pre-dose, every 15 
minutes during the infusion (e.g., 15, 30, 45, 60, 75, 90, 105, etc.), at the end of infusion and 
30 min, 1, 2, 3, 4, 6, 8 and 20 hours after the end of the infusion and 5, 7, 14, 28, 56, and 84 
days post-dose and in case of early termination visit.
Blood pressure will be measured in duplicate, after 5 minutes in the supine position. The single 
values and the average of duplicate blood pressure measurements will be reported in eCRF, and 
the average will be used to assess the subject’s eligibility. 

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7.2.9 Local 12-lead electrocardiogram
A triplicate 12-lead ECG will be performed to assess eligibility and a single 12-lead ECG will 
be evaluated at pre-dose on Day 1, and Days 2, 7, 28, and 84 days post-dose and in case of early 
termination visit. 
The following parameters will be recorded: heart rate, PR, QRS, and QTcF.
7.2.10 Physical examination
A comprehensive full physical examination or abbreviated symptom-directed physical 
examination will be performed at each visit. Any new revealed clinically significant 
abnormality since the last visit will be recorded as an AE. 
7.2.11 Optional blood collection for transcriptomic analysis
The following blood samples will be collected pre-dose on Day 1 and on Day 14:
2 × 2.5 mL of blood for whole blood transcriptomic analysis.
The processing, storage and shipment of samples are detailed in the Laboratory Manual 
document. The samples for transcriptomic analysis will be collected for exploratory purposes 
and will be retained until up to 20 years to be possibly used for post-hoc analysis and 
investigations. Results will not be part of the current statistical analysis and will not be included 
in the Clinical Study Report. Sample collection and analysis will only be conducted in subjects 
who have provided a separate and specific informed consent.
8.
PHARMACOKINETIC AND OTHER ASSESSMENTS
8.1 Pharmacokinetic Assessments
The following PK parameters will be calculated, whenever possible, for each subject based on 
the serum concentrations of CHF10067 following a single IV administration: 
Area under the concentration-time curve (AUC) from 0 to the last quantifiable 
concentration (AUC0-t)
AUC extrapolated to infinity (AUCinf)
Maximum observed concentration (Cmax)
Time to Cmax (tmax)
Concentration at steady state of infusion (Cinf)
Clearance (CL)
Volume of distribution (Vz)
Terminal half-life (t1/2).

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The PK analysis will be performed using WinNonlin Phoenix 6.2 or later (Pharsight 
Corporation, Palo Alto, CA, USA). Actual elapsed time from dosing will be used to estimate 
all individual PK parameters. Standard non-compartmental methods will be used for the 
calculation of the following parameters from the individual serum drug concentrations versus 
time profile. 
8.2 Other Assessments
Levels of TG2 in plasma will be collected for exploratory assessment. 
9.
SAFETY ASSESSMENTS
9.1 Safety Variables
Safety and tolerability will be assessed through the monitoring of the following: 
AEs and adverse drug reactions (ADRs)
Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, and body 
temperature)
Oxygen saturation measured via pulse oximetry
12-lead ECGs (heart rate, PR, QRS, and QTcF)
Clinical laboratory evaluations: clinical chemistry (including fasting glucose) and 
haematology
Physical examinations
Spirometry (FEV1, FVC, FEV1 % of predicted normal and lower limit of normal value, 
FVC % of predicted normal and lower limit of normal value, and FEV1/FVC ratio)
Diffusing capacity (DLCO [unadjusted], DLCO % predicted, DLCO corrected for 
haemoglobin, DLCO corrected for haemoglobin % predicted, KCO, and VA)
ADAs and nAb
Analysis of systemic markers* of immediate hypersensitivity reactions pre-dose and post-
dose (post-dose only if required) including: 
-
markers of cytokine release syndrome (IFN-γ, TNF-α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-
10, IL-12 (p70), and IL-13)
-
mast cell tryptase
-
complement markers (C3a, C5a, CH50, and SC5b-9)
-
CHF10067 IgE.
*During the study, the markers analysed may be adjusted as required. Any adjustment will be 
with consideration for subject safety and operational activities. 

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9.2 Emergency Situation
In case of health emergency, including COVID-19, the Investigator/site staff must take all 
necessary precautions to minimise and avoid the risk of transmission and exposure to study 
subjects and site staff, according to local guidelines. In that particular case: 
a time window for study visits could be allowed when subjects are not able to arrive to 
the site or to attend the visit
onsite study visits could be cancelled or replaced by phone calls, or some assessments 
could be missed. 
Special case of COVID-19 outbreak:
Every effort should be made by the site to confirm all suspected incidences of COVID-19 in 
accordance with local diagnostic guidelines. Documentation of testing and results obtained 
outside the clinical site, should be collected within 14 days of confirmed diagnosis (or whenever 
possible) and recorded in the eCRF. 
All incidences of COVID-19 as well as the impact on study visits and subject completion must 
be captured in the eCRF.
Occurrence of SARS-CoV-2 infection and/or COVID-19 disease during the study does not 
automatically lead to withdrawal of the subject. It will be up to the Investigator’s judgement to 
withdraw the subject from the study if he/she deems that remaining in the study will place the 
subject and/or the clinical site at undue risk by continuing their participation. All efforts should 
be made to keep the subject on study drug, if possible. 
In case study visits or procedures are modified or missed due to COVID-19, the relevant 
information will be recorded in the eCRF. 
As of the date of this protocol version, there is no specific treatment for COVID-19 and several 
vaccine therapies have been developed and approved by health authorities with vaccination 
campaigning being initiated worldwide. For all confirmed cases of COVID-19/SARS-CoV-2 
the Investigator must follow the standard of care in accordance with local treatment guidelines. 
All concomitant treatments must be recorded in the eCRF. 
In case of COVID-19 suspect, Investigators are encouraged to perform diagnostic testing 
locally or obtain results of tests from hospital where the event was diagnosed and/or managed, 
and every effort should be made to complete the assessments required by the current local 
guidelines for COVID-19 management (e.g., SARS-CoV-2 test, chest imaging) and to 
guarantee the appropriate management.

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10.
ADVERSE EVENT REPORTING
10.1 Definitions
An Adverse Event is “any untoward medical occurrence in a patient or clinical study subject 
administered a medicinal product and which does not necessarily have a causal relationship 
with this treatment”.
An AE can therefore be any unfavourable and unintended sign (including abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a medicinal product, 
whether or not considered related to the medicinal product.
An Adverse Drug Reaction is an “untoward and unintended responses to an investigational 
medicinal product related to any dose administered”.
All AEs judged by either the reporting Investigator or the Sponsor as having a reasonable causal 
relationship to a medicinal product qualify as adverse reactions. The expression “reasonable 
causal relationship” means to convey in general that there are facts (evidence) or arguments 
meant to suggest a causal relationship.
The definition covers also medication errors and uses outside what is foreseen in the protocol, 
including misuse and abuse of the product.
A Serious Adverse Event (SAE)/Serious Adverse Drug Reaction is any untoward medical 
occurrence or effect that at any dose falls in one or more of the following categories:
Results in death
Death is not an AE but an outcome. It is the cause of death that should be regarded as the AE. 
The only exception to this rule is “sudden death” where no cause has been established; in this 
latter instance, “sudden death” should be regarded as the AE and “fatal” as its reason for being 
serious.
Is life-threatening
Life-threatening refers to an event in which the subject was at risk of death at the time of the 
event (e.g., aplastic anaemia, acute renal failure, and anaphylaxis). The term does not refer to 
an event which hypothetically might have caused death if it were more severe.
Requires hospitalisation or prolongation of existing hospitalisation
Hospitalisation refers to a situation whereby an AE is associated with unplanned formal 
overnight admission into hospital, usually for purpose of investigating and/or treating the AE. 
Hospitalisation for the treatment of a medical condition that occurs on an “elective” or 
“scheduled” basis or for a pre-existing condition that did not worsen during the study should 
not necessarily be regarded as an AE. Complications that occur during the hospitalisation are 
AEs. If a complication prolongs hospitalisation, the event is an SAE. Emergency room visits 

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that do not result in a formal admission into hospital should be evaluated for one of the other 
seriousness criteria (e.g., life-threatening; persistent or significant disability or incapacity; 
medically significant).
Results in persistent or significant disability or incapacity
The term significant disability should be viewed as any situation whereby an AE has a clinically 
important effect on the subject’s physical or psychological well-being to the extent that the 
subject is unable to function normally.
Is a congenital anomaly or birth defect
Is a medically significant adverse event
This criterion allows for any situations in which important AE/adverse reactions that are not 
immediately life-threatening or do not result in death or hospitalisation may jeopardise the 
subject’s health or may require intervention to prevent one of the above outcomes.
Examples of such events are: intensive treatment in an emergency room or at home for allergic 
bronchospasm; blood dyscrasias or convulsions that do not result in hospitalisation; or 
development of drug dependency or drug abuse.
Medical and scientific judgment should be exercised in deciding whether an event is serious 
because medically significant.
Any suspected transmission via a medicinal product of an infectious agent is also considered a 
serious adverse reaction.
A Non-Serious Adverse Event/Non-Serious Adverse Drug Reaction is an AE or ADR that 
does not meet the criteria listed above for an SAE/serious adverse drug reaction.
10.2 Expectedness
An expected adverse reaction is an adverse reaction, the nature or severity of which is consistent 
with the applicable reference safety information (included in the IB for CHF10067) otherwise 
it is considered unexpected.
Reports which add significant information on specificity or severity of a known, already 
documented serious ADR constitute unexpected events. For example, an event more specific 
or more severe than described in the reference safety information would be considered as 
“unexpected”. Examples of such events are: (a) acute renal failure as a labelled ADR with a 
subsequent new report of interstitial nephritis and (b) hepatitis with a first report of fulminant 
hepatitis.
In the event an exacerbation is interpreted as due to lack of efficacy, it should not be classified 
as drug related.

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10.3 Intensity of Adverse Event
For the classification of AEs severity (except for immediate hypersensitivity reactions severity, 
see below), the Common Terminology Criteria for Adverse Events (CTCAE) [23] will be used:

Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated. 

Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-
appropriate instrumental Activities of Daily Living (ADL)*. 

Grade 3 Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting 
self-care Activities of Daily Living**. 

Grade 4 Life-threatening consequences; urgent intervention indicated. 

Grade 5 Death related to AE. 
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc. 
**Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden.
In order to guarantee objectivity and consistency in the evaluation of AEs (including 
classification of severity), the proposed guidance should be followed in alignment with best 
medical practice.
Laboratory abnormalities and other clinical assessments (e.g., 12-lead ECG) will be reported 
as AEs if judged by the Investigator as being clinically significant.
In case of laboratory evaluations or other clinical assessments (e.g., 12 -lead ECG) not listed in 
the CTCAE grading table, the AE severity will be judged by the Investigator based on the local 
ranges.
Taking into consideration the disease examined in the current study, it should be acknowledged 
that the guidance may not always be applied. Therefore, although the guidance should be 
followed, whenever possible, in order to ensure an accurate and objective evaluation of the AEs, 
the final decision on the severity classification remains the responsibility of the Investigator. 
For the specific classification of severity and management of immediate hypersensitivity 
reactions, refer to Section 7.2.2.5.1.

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10.4 Causality Assessment
The following “binary” decision choice will be used by the Investigator to describe the causality 
assessment:
Reasonable possibility of a relatedness
No reasonable possibility of relatedness.
The expression “reasonable possibility of relatedness” is meant to convey, in general, that there 
are facts (evidence), or arguments meant to suggest a causal relationship.
The Investigator will be asked to consider the following before reaching a decision on causality 
assessment:
Time relationship between study drug intake and event’s onset
Dechallenge (did the event abate after stopping drug?)
Rechallenge (did the event reappear after reintroduction?)
Medical history
Study treatment(s)
Mechanism of action of the study drug
Class effects
Other treatments-concomitant or previous
Withdrawal of study treatment
Lack of efficacy/worsening of existing condition
Erroneous treatment with study medication (or concomitant)
Protocol related process.
10.5 Action Taken with the Study Drug due to an Adverse Event
Dose not changed
Drug permanently withdrawn
Drug temporarily interrupted
Dose reduced
Dose rate reduced
Not applicable.
10.6 Other Actions Taken
Specific therapy/medication
Concomitant procedure.

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10.7 Outcome
Each AE must be rated by choosing among:
Recovered/resolved
Recovering/resolving
Not recovered/not resolved
Recovered with sequelae/resolved with sequelae
Fatal
Unknown.
10.8 Recording Adverse Events
All AEs occurring during the course of the study must be documented in the AE page of the 
eCRF. Moreover, if the AE is serious, the SAE Form must also be completed. 
It is responsibility of the Investigator to collect all AEs (both serious and non-serious) derived 
by spontaneous, unsolicited reports of subjects, by observation, and by routine open 
questionings.
The recording period for AEs is the period starting from the informed consent signature until 
the subject’s study participation ends.
Clinically significant abnormalities detected at screening visit not due to a pre-existing 
condition or clinically significant changes at the following visits in the medical opinion of the 
Investigator must be reported as AEs in the eCRF.
If a clinically significant abnormal laboratory finding or other abnormal assessment meets the 
definition of an AE, then the AE eCRF page must be completed, as appropriate. A diagnosis, if 
known, or clinical signs and symptoms if diagnosis is unknown, rather than the clinically 
significant abnormal laboratory finding, should be reported on AE eCRF page. If no diagnosis 
is known and clinical signs and symptoms are not present, then the abnormal finding should be 
recorded.
For pharmacovigilance purposes, all SAEs should be followed-up in order to elucidate as 
completely and practically as possible their nature and/or causality until resolution of all 
queries, clinical recovery is complete, laboratory results have returned to normal, stable 
condition is reached or until the subject is lost to follow-up. Follow-up may therefore continue 
after the subject has left the study. In this case, the follow-up will continue with no timelines 
for related SAEs, while for unrelated SAEs the type and extent of follow-up undertaken will be 
determined for each individual case and will depend upon the nature (e.g., events with poor 
prognosis or which do not resolve), severity, and medical significance of the event. 

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10.9 Reporting Serious Adverse Events to Chiesi
The Investigator must report all SAEs to the Fortrea Safety Contact listed below within 24 hours 
of awareness. The information must be sent by providing the completed paper SAE form. At a 
later date, the Fortrea Safety Contact will report all information to Chiesi Global 
Pharmacovigilance, the Clinical Project Manager, and the Clinical Research Physician.
Safety Contact
Fax No.
E-mail
Fortrea Safety Contact
+1 609 419 2609
SAEIntake@fortrea.com
Chiesi Safety Contact
+39 0521 1885003
CT_CDS@chiesi.com 
Reporting of SAEs from the Investigator site is from the time of subject’s signature of 
informed consent and until the subject’s study participation ends. After this date, even if 
no active monitoring of subjects is required, SAEs occurring to a subject should be 
reported if the Investigator becomes aware of them.
Up to the closure of the site, SAE reports should be reported to the Fortrea Safety Contact. 
New SAEs occurring after the site is closed should be reported directly to the Chiesi 
Safety Contact.
10.10 Reporting Serious Adverse Events to Regulatory Authorities/Ethics Committee
All SUSARs, which occur with the investigational medicinal products within or outside the 
concerned clinical study, if required, will be reported in compliance with the timelines and 
standards for reporting SUSARs. The Medicines and Healthcare products Regulatory Agency 
(MHRA) will be informed through MHRA Individual Case Safety Report (ICSR) Submission 
portal, while other relevant Regulatory Authorities in accordance with local requirements.  The 
ECs and the Investigators will be informed by Council for International Organisations of 
Medical Sciences I form or by periodic line listings produced by Chiesi Global 
Pharmacovigilance.
With regard to regulations in force for Pharmacovigilance, the Investigators must fulfil their 
obligation according to the law in force in their countries.
10.11 General Notes
In case of death, a comprehensive narrative report of the case should be prepared by the 
Investigator and sent to the Fortrea Safety Contact together with the SAE form, retaining 
a copy on site.
If an autopsy is performed, copy of autopsy report should be actively sought by the 
Investigator and sent to the Fortrea Safety Contact as soon as available, retaining a copy 
on site.

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All documents provided by the Investigator or site staff to the Fortrea Safety Contact must 
be carefully checked for respect of confidentiality. All personal subject’s data must be 
redacted.
In case of pregnancy discovered after treatment with study drug, the subject may remain 
on the study until completion for safety monitoring purposes, if these are considered safe 
by the Investigator. The subject will be asked (with a separate consent) to be followed 
with due diligence until the outcome of the pregnancy is known and till the age of one 
year of the child to detect any congenital anomaly or birth defect. The pregnancy must be 
reported by the Investigator within 24 hours by fax/e-mail to the Fortrea Safety Contact 
using the paper Pregnancy Report Form. The Fortrea Safety Contact will inform Chiesi 
of the pregnancy within 1 working day of being notified. 
The first 2 pages of the Pregnancy Report Form should be completed by the Investigator 
with all the available information and sent to the Fortrea Safety Contact. Information 
collected in specific sections relative to the pregnancy will be recorded in the form only 
upon signature of the specific ICF by the subject/subject’s partner. The third page will be 
completed as soon as the Investigator has knowledge of the pregnancy outcome, together 
with a follow-up of the first 2 pages, if necessary (e.g., an update in the medications 
received during pregnancy by the mother). If it meets the criteria for immediate 
classification of a SAE (e.g., spontaneous or therapeutic abortion, stillbirth, neonatal 
death, congenital anomaly, birth defect) the Investigator should follow the procedure for 
reporting SAEs. 
If it is the partner, rather than the subject, who is found to be pregnant, the same procedure 
regarding pregnancy reporting is to be followed and the Pregnancy Report Form should 
be completed. 
If the pregnancy is discovered before taking any dose of study drug, the pregnancy does 
not need to be reported; it is only required that the subject is immediately withdrawn from 
the study.
Any ADR occurring with any marketed non-investigational medicinal product and/or 
concomitant medication during the study must be reported by the Investigator to his/her 
concerned Health Authority and/or to the relevant Marketing Authorisation Holders of 
the involved medicinal products according to the applicable laws. Additionally, also 
conditions of use outside the marketing authorisation of the medicinal products (i.e., 
off-label, overdose, misuse, abuse, and medication errors) or from occupational exposure, 
as well as cases of suspected drug interaction, pregnancy, breast-feeding exposure and 
lack of efficacy should be reported.
11.
DATA MANAGEMENT
An eCRF will be filled in by the Investigator and/or his/her representative designee.
Front-end edit checks will run at the time of data collection and back-end edit checks will be 
used by the Data Manager to check for discrepancies and to ensure consistency and 
completeness of the data.

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Medical history, AEs, and concomitant procedures will be coded using the MedDRA 
dictionary; medications will be coded using the World Health Organisation Drug dictionary and 
Anatomical Therapeutic Chemical classification.
External data (PK, immunogenicity, immediate hypersensitivity reactions systemic markers, 
spirometry, diffusing capacity, plasma TG2 samples) will be processed centrally, sent to the 
designated Contract Research Organisation, and reconciled with the corresponding information 
recorded in the eCRF.
Access to electronic systems used for data collection will be granted to the study personnel only 
after appropriate training.
After the completion of data collection and cleaning, a review meeting will be held to determine 
the occurrence of any protocol violation and to define the subject populations for the analysis. 
Once the database has been declared to be complete and accurate, it will be locked, the 
randomisation codes will be opened, and the planned statistical analysis will be performed.
If the database is unlocked after the initial lock, the process must be carefully controlled and 
documented; updates to the study data must be authorised by Chiesi.
At the study conclusion, a complete copy of the study data will be created for archival purposes 
at Chiesi. The Investigators will receive copies of the subject data for retention at the 
investigational sites.
12.
STATISTICAL METHODS
12.1 Sample Size
This study is designed to explore the safety and tolerability of CHF10067 for the first time in 
subjects affected by IPF, while exposing a minimum number of subjects; therefore, no formal 
power calculation was performed. 
A sample size of 24 subjects (8 subjects per cohort; 6 treated with CHF10067 and 2 with 
placebo) is deemed adequate to assess safety and tolerability of CHF10067. In each cohort, a 
minimum of 2 subjects are required to be not receiving antifibrotic treatment (including subjects 
with previous use of antifibrotic treatment that has been stopped for at least 2 weeks prior to 
screening).
12.2 Analysis Sets
Safety set: all randomised subjects who receive a dose of study treatment, including partial 
dose.
PK set: all subjects from the safety population excluding subjects without any valid PK 
measurement or with important protocol deviations significantly affecting PK, for example, 
use of non-permitted medications. Exact definition of important protocol deviations 
significantly affecting PK will be discussed by the clinical team and described in a specific 

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document before bioanalytical data are disclosed. Subjects will not be excluded on the basis 
of statistical analysis or for PK reasons, except in the cases defined in the European Medicine 
Agency guideline [24]. 
After unblinding, subjects will not be excluded on the basis of statistical or for PK reasons, 
except in the case of:
non-zero baseline concentration > 5% of Cmax
AUC0-t lower than 5% of the reference medicinal product geometric mean of AUC0-t 
(calculated without inclusion of data from the outlying subject)
below the limit of quantification concentration at all timepoints.
Pharmacokinetic variables will be analysed in the PK set. The safety set will be used in the 
analysis of all safety variables. In case of deviation between randomised treatment and 
treatment actually received, the treatment actually received will be used (i.e., an as-treated 
analysis will be performed).
12.3 Statistical Analysis
Detailed statistical analysis will be described in the Statistical Analysis Plan (SAP). The plan 
will be finalised before breaking the blind. 
12.3.1 Descriptive statistics 
Descriptive statistics for PK variables (except for tmax) will include n (number of observed 
values), arithmetic mean, standard deviation (SD), coefficient of variation (CV), geometric 
mean, geometric CV, median, minimum, and maximum. The variable tmax will be summarised 
by using n, median, minimum, and maximum.
All individual concentration data and PK variables will be listed. In addition, a listing of the 
actual sampling times relative to study treatment administration will be provided. 
Concentrations will be summarised by treatment and scheduled sampling time by using n, 
arithmetic mean, SD, CV, median, minimum, and maximum.
Descriptive statistics for the other continuous variables will include n, arithmetic mean, SD, 
median, minimum, and maximum.
For categorical variables, the number and percentage of subjects with a specific level of the 
variable will be presented. Missing values will not be used in percentage calculations.
12.3.2 Missing data
Further details on dealing with missing data, along with the handling of possible outliers, will 
be described in the SAP. Other critical missing data, if any, will be discussed during the review 
of the data. Decisions will be fully documented in the Data Review Report.

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12.3.3 Subject demographics and baseline characteristics
The following variables will be summarised using descriptive statistics on the safety population 
(and on the PK population, if relevant): demographic characteristics (including age, sex, and 
race), height, weight, BMI, medical history and concomitant diseases, previous and 
concomitant medications, lung function, diffusing capacity, oxygen saturation, 12-lead ECG, 
vital signs, laboratories, and other safety parameters at screening and/or at baseline (pre-dose 
on Day 1).
12.3.4 Pharmacokinetic variables
CHF10067 serum AUC0-t, AUCinf, Cmax, tmax, Cinf, CL, Vz, and t1/2 will be summarised by dose 
level using descriptive statistics.
Serum concentration/time curves will be presented in linear/linear and log/linear scale. Plots 
will be presented by dose level, based on arithmetic means, and by subject, by showing the 
individual curves grouped by dose level (1 plot for each dose level) and ADA 
positivity/negativity (using different colours).
Dose proportionality in terms of CHF10067 AUC0-t, AUCinf, and Cmax will be evaluated using 
the power model, including the log-transformed PK parameters as dependent variables, and the 
log-transformed CHF10067 dose as a covariate. The slope for log-transformed dose will be 
estimated with its 90% confidence interval (CI) to examine dose proportionality.
12.3.5 Safety variables
All safety data will be listed. For all safety and immunogenicity variables, baseline is the last 
available assessment before the dose administration, which is either the screening assessment 
between Days -28 to -3 or the pre-dose assessment on Day 1.
12.3.5.1 Adverse events
The number of events and the number and percentage of subjects experiencing treatment 
emergent-adverse events (TEAEs), treatment-emergent ADRs, serious TEAEs, non-serious 
TEAEs, TEAEs by CTCAE grade, TEAEs leading to discontinuation of study drug and TEAEs 
leading to death will be presented by treatment. The aforementioned categories of AEs will be 
also summarised by System Organ Class and Preferred Term using the MedDRA dictionary.
12.3.5.2 Systemic markers for evaluation of immediate hypersensitivity reactions
Cytokine markers (IFN-γ, TNF-α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p70), and IL-13), 
mast cell tryptase, complement markers (C3a, C5a, CH50, and SC5b-9), and CHF10067 IgE 
will be presented by subject for each post-dose timepoint as absolute value and change from 
baseline (if collected).

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12.3.5.3 Immunogenicity 
Anti-drug antibody positive subjects will be defined as described in Section 7.2.2.4.
As a minimum, the following will be prepared: 
A table summarising for each ADA-positive subject:
-
dose administered
-
baseline ADA
-
maximal ADA timepoint
-
maximal ADA value
-
final ADA timepoint
-
final ADA value
-
pre-dose TG2 level
-
TG2 level at maximal ADA timepoint
-
CHF10067 AUCinf.
A table summarising for ADA-positive subject the ADA and nAb ranges by dose level.
12.3.5.4 Pulmonary assessments 
12.3.5.4.1 Spirometry 
The FEV1, FVC, FEV1/FVC, FEV1% of predicted and FVC% of predicted, will be summarised 
by dose level as absolute value, and absolute and relative change from baseline (i.e., the 
assessment at screening between Days -28 to -3) at each post-dose timepoint using descriptive 
statistics and 95% CIs. The frequency of subjects with FEV1% and FVC% below the lower 
limit of normal at each timepoint will be listed and summarised with descriptive statistics. 
Time profile plots by dose level will be presented for mean absolute and relative changes from 
baseline. 
12.3.5.4.2 Diffusing capacity
The DLCO unadjusted, DLCO % predicted, DLCO corrected for haemoglobin, and the other 
relevant variables collected will be summarised by dose level as absolute value and change 
from baseline (i.e., the assessment at screening between Days -28 to -3) at each post-dose 
timepoint using descriptive statistics and 95% CIs.
Time profile plots by dose level will be presented for DLCO corrected for haemoglobin and 
DLCO% predicted for mean changes from baseline. 
12.3.5.4.3 Oxygen saturation
The oxygen saturation will be summarised by dose level as absolute value and change from 
baseline (i.e., the pre-dose assessment on Day 1) at each post-dose timepoint using descriptive 

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statistics and 95% CIs. Time profile plots by dose level will be presented for mean changes 
from baseline. 
12.3.5.5 ECG
At each post-dose timepoint, the following statistics will be presented by dose level for 12-lead 
ECG parameters (heart rate, PR, QRS, QTcF): 
mean absolute value with its 95% CI
mean change from baseline (i.e., the pre-dose assessment on Day 1) with its 90% CI
mean placebo-corrected change from baseline with its 90% CI.
Time profile plots, individual and by dose level, will be presented for change from baseline 
(i.e., the pre-dose assessment on Day 1). Time profile plots of mean difference versus placebo 
in change from baseline will be presented by dose level for heart rate and QTcF.
The number and percentage of subjects with the following will be presented by dose level at 
each post-dose timepoint and at any post-dose timepoint:
Males: QTcF > 450 ms, > 480 ms, and > 500 ms
Females: QTcF > 470 ms and > 500 ms
Both sexes: change from baseline in QTcF > 30 ms and > 60 ms.
12.3.5.6 Vital signs
At each post-dose timepoint the following statistics will be presented by dose level for systolic 
and diastolic blood pressure, pulse rate, respiratory rate, and body temperature: 
mean absolute value with its 95% CI
mean change from baseline (i.e., the pre-dose assessment on Day 1) with its 95% CI.
Time profile plots, individual and by dose level, will be presented for change from baseline 
(i.e., the pre-dose assessment on Day 1). 
In addition, the number and percentage of subjects with a change from baseline > 20 mmHg for 
systolic blood pressure and > 10 mmHg for diastolic blood pressure will be presented by 
treatment at each post-dose timepoint and at any post-dose timepoint.
12.3.5.7 Safety laboratory data
At each post-dose timepoint quantitative laboratory parameters will be summarised by 
treatment as absolute value and change from baseline using descriptive statistics and 95% CIs. 
Shift tables from baseline to the minimum and the maximum post-dose value, with regards to 
normal range, will be presented by treatment.

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Urinalysis parameters will be presented in the listings.
12.3.6 Other variables
12.3.6.1 TG2 in plasma
At each post-dose timepoint, TG2 levels in plasma will be summarised using descriptive 
statistics by treatment as absolute value and change from baseline (i.e., the pre-dose assessment 
on Day 1) using descriptive statistics and 95% CIs.
Time profile plots will be presented by dose level, based on arithmetic means, and by subject, 
by showing the individual curves grouped by dose level (1 plot for each dose level) and ADA 
positivity/negativity (using different colours).
The TG2 levels in plasma obtained from healthy subjects will be summarised using descriptive 
statistics.
Box-plots summarising the pre-dose levels for treated subjects in the study, the healthy subjects’ 
external group, and each post-dose levels for the different doses for treated subjects will be 
presented. 
12.3.7 Interim analysis
Interim analysis not planned. 
13.
ETHICS COMMITTEE 
The study proposal will be submitted to the EC in accordance with the local requirements.
The EC shall give its opinion in writing, clearly identifying the study number, study title and 
ICF approved, before the clinical study commences.
A copy of all communications with the EC will be provided to the Sponsor.
The Investigator should provide written reports to the EC annually or more frequently if 
requested on any changes significantly affecting the conduct of the study and/or increasing risk 
to the subjects (according to the requirements of each country).
14.
 REGULATORY REQUIREMENTS
The study will be notified to the Health Authorities (or authorised by) according to the legal 
requirements.
Selection of the subjects will not start before the approval of the EC has been obtained and the 
study notified to Health Authorities (or authorised by).

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15.
INFORMED CONSENT 
Informed consent must be written in a language understandable to the subjects. It is the 
responsibility of the Investigator to obtain written consent from each subject prior to any study 
related procedures taking place, by using the latest EC approved version of the document.
Adequate time shall be given to the subject to enquire to the Investigator about any clarification 
needed and to consider his or her decision to participate to the study.
If the subject is unable to read, the informed consent will be obtained in the presence of an 
impartial witness, e.g., a person independent of the study who will read and sign the ICF and 
the written information for the subject.
Consent must be documented by the subject’s dated signature. The signature confirms that the 
consent is based on information that has been understood. Moreover, the Investigator must sign 
and date the ICF.
Each subject’s signed informed consent must be kept on file by the Investigator. One copy must 
be given to the subject.
For subjects who agree to the collection of optional samples for transcriptomic analysis, 
separate informed consent must be obtained and the separate optional ICF signed prior to 
collection.
Female subjects becoming pregnant during the study and partner of a subject participating to 
the study becoming pregnant will have to sign a specific informed consent form to provide 
permission to Chiesi to collect information about the pregnancy, its outcome and the birth and 
health of the newborn child.
16.
SOURCE DOCUMENTS/DATA
16.1 Recording of Source Data
Data collection is the responsibility of the clinical study staff at the site under the supervision 
of the site Investigator. The Investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. All source documents should be completed in a 
neat, legible manner to ensure accurate interpretation of data. 
Data recorded in the eCRF transcribed from source documents should be consistent with the 
data recorded on the source documents.
16.2 Direct Access to Source Document/Data
The Investigators or designee must permit study-related monitoring, audits, EC review, or 
regulatory inspection, providing direct access to source data/documents.

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17.
STUDY MONITORING
Monitoring will be performed by Fortrea who have been designated by Chiesi.
It is understood that the monitor(s) will contact and visit the Investigator/site before the study, 
regularly throughout the study and after the study had been completed, and that they will be 
permitted to inspect the various study records: case reports form, Investigator study file, and 
source data, provided that subject confidentiality is respected.
The purposes of these visits are:
to assess the progress of the study
to review the compliance with the study protocol
to discuss any emergent problem
to check the eCRFs for accuracy and completeness
to validate the contents of the eCRFs against the source documents
to assess the status of drug storage, dispensing, and retrieval.
Prior to each monitoring visit, the Investigator or staff will record all data generated since the 
last visit on the case report forms. The Investigator and/or study staff will be expected to be 
available for at least a portion of the monitoring visit to answer questions and to provide any 
missing information.
It is possible that the Investigator site may be audited by Sponsor personnel or regulatory 
national and/or international regulatory agencies during and after the study has been completed.
18.
QUALITY ASSURANCE
The R&D Quality Assurance Department of Chiesi may perform an audit at any time according 
to the Sponsor’s Standard Operating Procedures, in order to verify whether the study is being 
conducted in agreement with GCP and the protocol.
19.
INSURANCE AND INDEMNITY 
Chiesi holds and will maintain an adequate insurance policy covering damages arising out of 
Chiesi’s sponsored clinical research studies.
Chiesi will indemnify the Investigator and hold him/her harmless for claims for damages arising 
out of the investigation, in excess of those covered by his/her own professional liability 
insurance, providing that the study treatment was administered under his/her or deputy’s 
supervision and in strict accordance with accepted medical practice and with the study protocol.
The Investigator must notify Chiesi immediately upon notice of any claims or lawsuits.

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20.
CONFIDENTIALITY
All study documents are provided by the Sponsor in confidence to the Investigator and his/her 
appointed staff. None of this material may be disclosed to any party not directly involved in the 
study without written permission from Chiesi.
The Investigator must assure the subject’s anonymity will be maintained. The Investigator will 
keep a separate list with at least the initials, the subject’s study numbers, names, and addresses 
and telephone numbers (if applicable). The Investigator will maintain this for the longest period 
of time allowed by his/her own institution and, in any case, until further communication from 
Chiesi.
21.
PREMATURE TERMINATION OF THE STUDY 
Both the Sponsor and the Investigator reserve the right to terminate the study at any time. 
Should this be necessary, the procedures for an early termination or temporary halt will be 
arranged after consultation by all involved parties.
The Sponsor should submit a written notification to the Regulatory Authorities concerned and 
EC providing the justification of premature ending or of the temporary halt.
22.
CLINICAL STUDY REPORT
The Clinical Study Report, including the statistical and clinical evaluations, shall be prepared 
and sent to Coordinating Investigator for agreement and signature.
At the end of the study a summary of the Clinical Study Report will be provided to all EC, to 
the Competent Authorities and to Investigators.
23.
RECORD RETENTION
After completion of the study, all documents and data relating to the study will be kept in an 
orderly manner by the Investigator in a secure study file.
Regulations require that essential documents must be retained for at least 2 years after the final 
marketing approval in an ICH region or until 2 years have elapsed since the formal interruption 
of the clinical development of the product under study.
It is the responsibility of the Sponsor to inform the Investigator of when these documents can 
be destroyed. The Investigator must contact Chiesi before destroying any study-related 
documentation. In addition, all subjects’ medical records and other source documentation will 
be kept for the maximum time permitted by the institution.
24.
PUBLICATION OF RESULTS
Chiesi is entitled to publish and/or present any results of this study at scientific meetings, and 
to submit the clinical study data to national and international Regulatory Authorities and, if they 

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fall under the Chiesi commitments on Clinical Trial Transparency, to make them available on 
www.chiesi.com website.
Chiesi furthermore reserves the right to use such data for industrial purposes.
In the absence of a Study Steering Committee, Investigators will inform Chiesi before using the 
results of the study for publication or presentation and agree to provide the Sponsor with a copy 
of the proposed presentation. Data from individual clinical sites must not be published 
separately. 

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25.
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[2] American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. 
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investigation-bioequivalence-rev1_en.pdf

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APPENDIX 1 - APPROVAL OF THE PROTOCOL BY 
COORDINATING CLINICAL INVESTIGATOR
A PHASE IB, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED 
STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND 
PHARMACOKINETICS OF AN INTRAVENOUS MONOCLONAL ANTIBODY 
(MAB) AFTER SINGLE ASCENDING DOSES IN SUBJECTS AFFECTED BY 
IDIOPATHIC PULMONARY FIBROSIS
Product: CHF10067 
Pharmaceutical Form: Solution for intravenous infusion
Approval of Clinical Study Protocol by the Investigator: 
I have carefully read this protocol and I agree that it contains all the necessary information 
required to conduct the study and I agree to conduct it as described.
I understand that this study will not be initiated without Ethics Committee approvals and that 
the administrative requirements of the governing body of the institution will be fully complied 
with.
Informed written consent will be obtained from all participating subjects and appropriately 
documented, prior to their enrolment in the study. 
The undersigned agrees that the study will be carried out in conformity with the Declaration of 
Helsinki (as applicable, with attention being drawn to Section concerning freely given consent), 
ICH E6 Good Clinical Practices and with all the other local laws and regulations relevant to the 
use of new and approved therapeutic agents in subjects.
Coordinating Investigator’s Name and Qualifications: ______________________, ______
Centre No.: 
_____________________
          Signature
Date
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma - Italy

Clinical Study Protocol – Appendix 2
Clinical Study Code No.: CLI-10067AA1-01
Version No.: 6.0
EUDRACT No.: 2022-001079-15
Date: 06 July 2023
CONFIDENTIAL
Page 72/73
APPENDIX 2 - APPROVAL OF THE PROTOCOL BY 
CLINICAL INVESTIGATOR(S)
A PHASE IB, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED 
STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND 
PHARMACOKINETICS OF AN INTRAVENOUS MONOCLONAL ANTIBODY 
(MAB) AFTER SINGLE ASCENDING DOSES IN SUBJECTS AFFECTED BY 
IDIOPATHIC PULMONARY FIBROSIS
Product: CHF10067 
Pharmaceutical Form: Solution for intravenous infusion
Approval of Clinical Study Protocol by the Investigator: 
I have carefully read this protocol and I agree that it contains all the necessary information 
required to conduct the study and I agree to conduct it as described.
I understand that this study will not be initiated without Ethics Committee approvals and that 
the administrative requirements of the governing body of the institution will be fully complied 
with.
Informed written consent will be obtained from all participating subjects and appropriately 
documented, prior to their enrolment in the study. 
The undersigned agrees that the study will be carried out in conformity with the Declaration of 
Helsinki (as applicable, with attention being drawn to Section concerning freely given consent), 
ICH E6 Good Clinical Practices and with all the other local laws and regulations relevant to the 
use of new and approved therapeutic agents in subjects.
Investigator’s Name and Qualifications: ______________________, ______
Centre No.: 
__________________________
       Signature
Date
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma - Italy
 

Clinical Study Protocol – Appendix 3
Clinical Study Code No.: CLI-10067AA1-01
Version No.: 6.0
EUDRACT No.: 2022-001079-15
Date: 06 July 2023
CONFIDENTIAL
Page 73/73
APPENDIX 3 - RECOMMENDATIONS RELATED TO 
CONTRACEPTION AND PREGNANCY TESTING IN 
CLINICAL STUDIES
Definition of female of childbearing potential and of fertile men
For the purpose of this document, a woman is considered of childbearing potential (WOCBP), i.e., fertile, 
following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation 
methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high 
follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal 
state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 
12 months of amenorrhea, a single FSH measurement is insufficient.
For the purpose of this document, a man is considered fertile after puberty unless permanently sterile by bilateral 
orchidectomy.
Birth control methods, which may be considered as highly effective
For the purpose of this guidance, methods that can achieve a failure rate of less than 1% per year when used 
consistently and correctly are considered as highly effective birth control methods. Such methods include:
• combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:

oral

intravaginal

transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation:

oral

injectable

implantable 3
• intrauterine device  3
• intrauterine hormone-releasing system3
• bilateral tubal occlusion 3
• vasectomised partner 1, 3
• sexual abstinence 2
1 Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of 
the WOCBP study subject and that the vasectomised partner has received medical assessment of the surgical 
success.
2 Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence 
needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the 
subject.
3 Methods with low-user dependency
Clinical Trial Facilitation Group guidance: Recommendations related to contraception and pregnancy 
testing in clinical trials. Final version 1.1, 21/09/2020.