A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE AND/OR MULTIPLE INTRAVENOUS AND/OR SUBCUTANEOUS DOSES OF PF-06817024 IN HEALTHY SUBJECTS WHO MAY BE MILDLY ATOPIC, SUBJECTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS, AND SUBJECTS WITH MODERATE-SEVERE ATOPIC DERMATITIS
Phase: PHASE1
Conditions: Healthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis
Sponsor: Pfizer

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CLINICAL PHARMACOLOGY PROTOCOL
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN,
PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE
SAFETY, TOLERABILITY, PHARMACOKINETICS AND
PHARMACODYNAMICS OF SINGLE AND/OR MULTIPLE INTRAVENOUS
AND/OR SUBCUTANEOUS DOSES OF PF-06817024 IN HEALTHY SUBJECTS
WHO MAY BE MILDLY ATOPIC, SUBJECTS WITH CHRONIC
RHINOSINUSITIS WITH NASAL POLYPS, AND SUBJECTS WITH 
MODERATE-SEVERE ATOPIC DERMATITIS
Compound:
PF-06817024
Compound Name:
Not Applicable
United States (US) Investigational New
Drug (IND) Number:
(Atopic Dermatitis IND): 
European Clinical Trials Database
(EudraCT) Number:
Not Applicable
Protocol Number:
C0341001
Phase:
1
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Document History
Document
Version Date
Summary of Changes and Rationale
Amendment 5
22 May 2018
 
 
 
 
•
SOA Tables B, C and D: Added footnote 
for safety labs at extended follow-up visits 
for Parts 1 and 2 (cohorts currently in the 
study) to be done at the discretion of the 
PI.
Rationale: to allow for follow-up of safety 
labs if needed.
 
 
 
 
•
SoA Table E (Part 3): 4 hr post-dose PK 
sample collection has been eliminated. 
Blood volume table (Table 8) in 
Section 7.2.5 has been updated to reflect 
this change.
Rationale: revision made to reduce the 
length of the visit.
•
Section 1.2.3: Nonclinical 
pharmacokinetics section has been 
updated.
Rationale: revision made to align with 
updated IB.
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
Section 1.2.4: Nonclinical safety section 
has been updated.
Rationale: revision made to align with 
updated IB.

Section 1.2.5.1: Clinical safety section has 
been updated.
Rationale: revision made to align with 
updated IB.

Section 1.2.5.2: Clinical PK section has 
been updated.
Rationale: revision made to align with 
updated IB.

Sections 1.3.1.2 and 3.1.3 (Part 3)–
Randomization ratio has been changed 
from 2:1 to 3:1 (PF-06817024: placebo).  
Total number of subjects in the study will 
be adjusted based on the emerging data 
from the Atopic Dermatitis cohort.
Rationale: revision made to optimize the 
study design and minimize the number of 
subjects receiving placebo.

Section 1.3.1.3 (Parts 1, 2 and 3)–
Language added around current guidance
on discharge of subjects from the study.
Rationale: to inform the sites of the 
current guidance for discharge of subjects 
from the study.

Section 1.3.2 (Parts 1, 2 and 3)–safety 
margins are updated based on emerging 
data.
Rationale: to align with IB.

Figure 2 in Section 3.1 updated for Part 3.

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Rationale: to reflect the randomization 
ratio of 3:1 and possible adjustment of 
total number of subjects.

Section 4.1.1.1 (Part 3)–Revised Inclusion 
criterion #2 to allow subjects between the 
ages of 18 and 75 years, inclusive, with 
Sponsor discussion for ages greater 
than 70.
Rationale: to facilitate recruitment.

Section 4.1.1 (Part 3)–Revised Inclusion 
criterion #6 to allow subjects with 
BMI 17.5 to 40 kg/m2.
Rationale: to facilitate recruitment.

Section 4.1.1 (Part 3)– Inclusion 
criterion #7c has been revised to correct
IGA and EASI criteria to be consistent 
with moderate-severe AD (defined as 
having an affected BSA (captured as part 
of EASI) 10%, IGA 3, and EASI 12 at 
the screening and baseline visits).
Rationale: Typographical errors corrected.

Section 4.1.2.1 (Part 3)– Exclusion 
criterion #16 has been revised to permit 
subjects with sensitivity and/or 
anaphylaxis to a single avoidable allergen 
(eg, aspirin, penicillin, sulfadrugs, 
nonsteroidal anti inflammatory drugs 
(NSAIDs), peanuts) provided they carry 
appropriate treatment for anaphylaxis,
know how to manage the anaphylactic 
reactions , and avoid the allergen.
Rationale: revised to allow inclusion of
subjects with sensitivity to a single 
avoidable allergen (eg, aspirin, penicillin, 
sulfadrugs, nonsteroidal anti inflammatory 
drugs (NSAIDs), peanuts) that would not 
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participating in the trial in recognition of 
frequent comorbidity of these sensitivities 
with allergic disease.

Section 4.1.2.1 (Part 3)– Exclusion 
criterion #18 has been updated to exclude 
subjects with a positive urine drug screen
except marijuana where use is permitted 
by local law and regulations. 
Rationale: to provide clarification to urine 
drug screen testing.

Section 4.1.2.1 (Part 3)– Exclusion 
criterion #24 has been updated to exclude 
subjects with prior or current use of 
anti-IL-33 targeted therapies.  
Section 5.9.2 Prohibited Medications for 
Part 3 has been updated to include 
Anti-IL-33 therapies. 
Rationale: to avoid selection bias and 
interference with interpretation of the 
results of the current study in recognition 
of other drugs targeting IL-33 in clinical 
development.

Section 4.1.2.1 (Part 3)– Exclusion 
criterion #24 has been revised to change 
the wash-out period for dupilumab from 
6 months to 4 months of first dose of 
study drug.
Rationale: adjustment based on reported 
PK of dupilumab.

Section 4.1.2.1 (Part 3)– Exclusion 
criterion #24 has been revised to change 
the wash-out period for steroids from 
6 weeks to 4 weeks prior to first dose of 
study drug.
Rationale: adjustment to wash-out period 
is based on half-life of steroids.

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
Section 4.2 (Part 3)–Randomization ratio 
has been changed from 2:1 to 3:1 
(PF-06817024: placebo).  Total number of 
subjects in the study will be adjusted 
based on the emerging data from the 
Atopic Dermatitis cohort.
Rationale: revision made to optimize the 
study design and minimize the number of 
subjects receiving placebo.

Section 4.3.2.4 is updated with language 
around sexual abstinence and use of 
selected and approved contraception 
method for a long enough period prior to 
dosing to ensure that the selected 
contraception method is effective at the 
time of the first dose of study drug.  
Contraception check and pregnancy 
results will be documented in the CRF.
Rationale: Administrative clarification for 
language around sexual abstinence. 
Contraception check and pregnancy 
testing documentation in CRF added to 
enable monitoring of subjects for use of 
contraception per protocol.

Section 4.3.2.5 clarifies that the travel 
restrictions stipulated in Section 4.3.1.4 
for Parts 1 and 2 are also applicable to 
Part 3.
Rationale: Administrative clarification.

Section 4.3.2.6 is updated and requires 
that subjects to the extent possible, have 
all elective surgical procedures be 
performed before enrolling into the study 
or deferred as long as possible after the 
active dosing period is complete (and 
preferably until after 1 year).
Rationale: to inform investigators and 
subjects of the unknown effects of the 

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study drug on wound healing in the event 
of a surgery.
•
Section 5.9.2.1 Rescue medications has 
been added with respect to subject access 
to standard of care treatment for the 
disease in the study.
Rationale: To clarify that subjects have 
access to standard of care treatments for 
flares in their atopic dermatitis during the 
study with investigator judgment as to the 
judicious addition of such treatments.
•
Administrative changes and sentence 
revisions made through out the document. 
Rationale: Revisions made to remove 
inconsistencies, incorporate PACLs, 
correct grammatical, spelling or other 
errors, and provide more clarity.
Amendment 4
03 August 2017
•
Addition of Atopic Dermatitis (AD) 
Cohort to explore safety, tolerability, 
 
 in subjects with 
moderate – severe AD to provide data to 
support potential future development in 
AD. The following Sections of the 
protocol have therefore been updated: 
•
Title.
•
SoA Table E.
•
Introduction (Section 1.1, 
Section 1.2.1.2, Section 1.3.1.2, 
Section 1.3.2.3).
•
Study Objectives and Endpoints 
(Section 2).
•
Study Design (Section 3.1.3).
•
Inclusion (Section 4.1.1.1) and 
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Exclusion (Section 4.1.2.1) Criteria.
•
Randomization Criteria 
(Section 4.2.1).
•
Lifestyle Guidelines (Section 4.3.2).
•
Removed overnight fasting of at least 
10 hours for receiving IP for the AD 
cohort as it is not a requirement for IV 
administration
 
 
.
•
Permitted (Section 5.8.3), and 
Prohibited (Section 5.9.2) 
Concomitant Treatments.
•
Study Procedures (Section 6.2).
•
Assessments (Section 7.2).
•
Data Analysis/Statistical Methods 
(Section 9.0, Section 9.1, Section 9.4, 
Section 9.5).
•
Figure 2.
•
Tables 6, 8, 9, 10, 11.
•
Appendices 7, 8, 9, 10, 11, 12, 13, 14, 
15, 16 and 17).
•
References from 51-61.
•
An update to the preliminary 
estimated half-life to 90 days for
Part 3 in Section 1.3.1.3 and 1.3.2.3, 
SOA Table E Footnote “a”.
•
Added emerging PK and Safety Data 
as follows in support of inclusion of 
AD cohort in study (Section 1.2.5 and 
includes Table 1 on Emerging Clinical 
Pharmacokinetics Based on 
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Preliminary Draft Dataset).
•
 
 
 
 
 
 
 
 
 
•
Section 9: Added language to allow for 
analysis and reporting of summarized 
unblinded preliminary safety, PK, 
 
data prior to LSLV as follows: In 
addition, summarizations of unblinded 
preliminary safety, PK, 
 may be 
performed for each part after Week 12 
safety, PK, 
 data have been 
obtained from a majority of subjects in 
that Part, as applicable, but prior to the 
end of the study and full safety follow-up. 
Further details will be defined in the SAP.  
 
 
Rationale: allows for communication of 
safety and tolerability data to IRBs / ECs, 
FDA and other Regulatory Authorities in 
advance of LSLV which may be 
protracted due to the prolonged t½ 
suggested by emerging PK data.
 
 
 
 
 
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•
Minor administrative changes : Updated 
section numbers referenced in Part 1 and 2
parts of the protocol. Rationale : Some 
section numbers changed due to the 
addition of Part 3 as follows. These are 
(i) Exclusion criteria 8 – Lifestyle 
Guidelines Section 4.3.1 updated to 
Section 4.3.1.5, (ii) Exclusion criteria 9 
Section 7.1.1 updated to Section 7.1.1.1, 
(iii) Prohibited Concomitant Medication 
for Part 2 - Section 5.9 updated to 
Section 5.9.1.
Amendment 3
26 October 2016
•
Revised “Extended Immunogenicity 
Follow-up” to ”Extended Follow-up”
(SoA Tables B, C, and D, and 
Section 6.3), and added language to 
specify additional follow-up visits to 
cover projected prolonged exposure due to 
the longer than expected t½ (Tables B and 
D footnotes a, Table C footnote b, and 
Sections 1.3.1 and 6.3). Rationale: to 
address extended half-life predictions that 
increase the likelihood of additional
subject visits to monitor safety and PK.
 
 
 
 
 
 
 
 
 
•
Added visit window to Extended 
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Follow-Up (Tables B, C, and D).  
Rationale: operational feasiblity. 
•
Removed “serum” from pregnancy test 
(Table D, Sections 6.1, 6.2.1, 6.2.3, 6.2.4, 
6.2.5, 6.2.6, and 6.4).  Rationale: 
alignment with Section 7.1.2 description 
of acceptable pregnancy tests. 
 
 
 
 
 
•
Revised language for the Day 0 visit for 
Part 2. This visit may be completed as an 
outpatient visit (Table D footnote w and 
Section 6.2.1). Rationale: operational 
feasibility.
•
Revised language in Part 2 clarifying 
spirometry screening procedure is for 
subjects with a history of asthma only 
(Table D footnote f, and Sections 6.1 and 
7.6).  Rationale: administrative 
clarification. 
•
Revised objective, endpoints, and study 
design to clarify Cohort 7 may consist of 
one or more doses (Section 1.3.1, 2.1.1, 
2.2.2, and 3.1). Rationale: administrative 
clarification to address that Cohort 7 may 
be one or more doses to be defined in light 
of emerging data. 
•
Revised Part 2 study design by removing 
sequential dosing and administration of 
higher dose prior to lower dose 
(Section 3.1). Rationale: to provide 
flexibility for Part 2 dosing due to 
extended half-life predictions. 
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
Revised Part 2 study design removing 
strata of asthmatics and non-asthmatics 
and adding flexibility of randomizing 
Cohorts 8 and 9 at either 1:1 or 2:1 ratio 
(Sections 1.3.1, 3.1, 4.2, and 9.1 and 
Figure 1). Rationale: randomization ratio 
modified to enable option to conduct only 
1 cohort of patients with CRSwNP while 
ensuring an adequate number of placebo 
subjects. Stratification of CRSwNP 
patients based on asthma comorbidity 
eliminated as the number of subjects 
recruited would be too limited to make a 
covariate analysis based on asthma status 
meaningful. 

Revised Phadiatop and IgE inclusion 
criteria noting Cohort 1 through 
4 replacement subjects were exempt 
(Section 4.1.1).  Rationale: administrative 
clarification. 

Revised exclusion criteria for Part 2 
permitting subjects with known sensitivity 
and/or anaphylaxis to aspirin or 
nonsteroidal anti-inflammatory drugs 
(NSAIDs) if the subject is aware of the 
hypersensitivity and avoids 
aspirin/NSAIDs (Section 4.1.2). 
Rationale: modification for patients with 
CRSwNP to remove exclusions for certain 
frequent comorbid conditions (eg, aspirin 
hypersensitivity) that do not impact 
overall safety of subjects participating in 
the trial to assist with logistical feasibility.

Revised exclusion criteria for Part 2 
permitting subjects with sinus infections 
that have not required antibiotic treatment 
within 28 days prior to screening 
(Section 4.1.2). Rationale: modification 
for patients with CRSwNP to remove 
ambiguities (eg, with respect to nasal 
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impact overall safety of subjects 
participating in the trial to assist with 
logistical feasiblity. 

Revised exclusion criteria for Part 2 
providing additional clarification for 
parenteral corticosteroids and limiting 
systemic corticosteroid steroids to 
6 weeks before screening (Section 4.1.2).  
Rationale: administrative clarification to 
assist with logisticial feasibility.

Revised exclusion criteria for Part 2 
regarding nasal surgeries (Section 4.1.2). 
Rationale:modification for patients with 
CRSwNP to remove ambiguities (eg, with 
respect to nasal surgery and sinus 
infections) that do not impact overall 
safety of subjects participating in the trial 
to assist with logistical feasiblity. 

Revised exclusion criteria for Part 2 
specifing subjects with a history of 
asthma, and clarifying systemic steroid 
treatment within 2 months prior to 
screening and dose of inhaled 
corticosteroids per day (Section 4.1.2). 
Rationale: administrative clarification and
modification to assist with logistical 
feasibility.

Revised limited physical examination to 
include skin and gastrointestinal system 
(Section 7.1.3). Rationale: administrative 
clarification. 

Revised immunogenicity language 
(Section 7.2.2). Rationale: company-wide 
updates to immunogenicity language. 

Revised computerized axial tomography 
(CT) scan language to clarify potential to 
perform repeat CT scans if initial scans 
are unreadable (Section 7.10). Rationale: 

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to ensure collection of usable CT data 
while providing administrative 
clarification that subjects remain within 
the FDA limits for annual radiation 
exposure.

Minor administrative corrections. 
Amendment 2
09 August 2016

Revised protocol title; SoA Table A, B, 
and C titles; Section 1.3.1, 2.1.1, 2.1.2, 
and 3.1; and Figure 1 to healthy subjects 
may be mildly atopic (but are not required 
to be mildly atopic). 
Rationale: administrative change in 
alignment with alterations to inclusion 
criteria for Part 1 Cohorts 5 and later. 

Added ECG and vital sign collection time 
may occur up to 10 minutes prior to 
investigational product infusion 
completion (SoA Table A footnote a, 
Table C footnote c, Table D footnote b, 
Section 6.2.2 and 6.2.8).  
Rationale: operational feasibility.

Revised Phadiatop collection to prior to 
dosing for Part 1 only (Cohorts 5 and 
later) (SoA Table A footnote k, 
Section 6.1, and Tables 3 and 5). 
Rationale: administrative change in 
alignment with alterations to inclusion 
criteria for Part 1 Cohorts 5 and later.

Revised IgE collections to at least two (2) 
pre-dose collections for Part 1 only 
(Cohorts 5 and later) (SoA Table A 
footnote o, Section 6.1, and Table 5). 
Rationale: administrative change in 
alignment with alterations to inclusion 
criteria for Part 1 Cohorts 5 and later.

Added post-dose time point guidance if 
intravenous infusion time exceeds 
100 minutes (SoA Table A footnote q, 

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Table C footnote l, Table D footnote s, 
Section 6.2.2 and 6.2.8).  
Rationale: administrative change for 
clarification. 
•
Revised Hepatitis B exclusion criteria 
starting with Cohorts 5 and later 
(Section SoA Table A footnote r, Table D 
footnote t, 4.1.2 and Table 3).  
Rationale: clarification for subjects testing 
HBsAg- and HBcAb+. 
•
Revised Day 46 and Day 61 visit windows 
to ±5 days (SoA Table B, Table C, 
Table D (Day 61 only)).  
Rationale: operational feasibility. 
•
Added guidance surrounding follow-up 
visits based upon second dose (Table B 
footnote d, Table C footnote a, and 
Section 6.2.7).  
Rationale: administrative change for 
clarification. 
•
Revised second dose window to a 
maximum of 12 weeks (SoA Table C 
footnote a, Section 1.3.1, 1.3.2, and 3.1). 
Rationale: operational feasibility. 
•
Altered Phadiatop inclusion criteria to 
include Part 1 only Cohorts 1-4 (SoA 
Table D, and Section 4.1.1).  
Rationale: operational feasibility.
•
Altered IgE inclusion criteria to include 
Part 1 only Cohorts 1-4 (SoA Table D, 
and Section 4.1.1).  
Rationale: operational feasibility. 
 
 
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
Added number of subjects whose safety 
results are required as part of the second 
dose prerequisite (Table 2). 
Rationale: administrative change for 
clarification.

Revised times surrounding meals 
(Section 4.3.1). 
Rationale: operational feasibility.

Revised study drug administration time 
(Section 5.4.3). 
Rationale: operational feasibility. 

Added language surrounding Part 2 
randomized subjects receiving prohibited 
treatments and medications (Section 5.9). 
Rationale: additional information 
requested by regulatory agency. 

Added Clinical Criteria for Diagnosing 
Anaphylaxis Guidance (Appendix 6, SoA 
Table A footnote s, Table C footnote m, 
and Table D footnote v). 
Rationale: additional information 
requested by regulatory agency. 

Minor administrative corrections.
Amendment 1
06 May 2016

Altered window surrounding dosing time
point (section 5.4.3).
Rationale: operational feasibility. 

Included drug stability information 
(section 5.6).
Rationale: additional information 
requested by regulatory agency.

Revised screening details to add clarity 
around Day 0 procedures and assessments 
(section 6.1). 
Rationale: administrative change for 
clarification. 

Minor administrative corrections.

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Original protocol
14 March 2016
Not applicable (N/A)
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and institutional review boards (IRBs)/ethics committees 
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TABLE OF CONTENTS
LIST OF TABLES...................................................................................................................25
LIST OF FIGURES .................................................................................................................25
APPENDICES .........................................................................................................................26
SCHEDULE OF ACTIVITIES................................................................................................27
1. INTRODUCTION ...............................................................................................................46
1.1. Mechanism of Action/Indication.............................................................................46
1.1.1. Mechanism of Action .................................................................................46
1.1.2. Indication....................................................................................................46
1.2. Background .............................................................................................................47
1.2.1. Drug Development Rationale .....................................................................47
1.2.1.1. Chronic Rhinosinusitis (CRS)...................................................47
1.2.1.2. Moderate to Severe Atopic Dermatitis......................................47
1.2.2. Nonclinical Pharmacology..........................................................................49
1.2.3. Nonclinical Pharmacokinetics ....................................................................50
1.2.4. Nonclinical Safety Data..............................................................................50
1.2.5. Emerging, Preliminary, Draft Data from Healthy Subjects in Parts 1, 
2 and/or 3 .........................................................................................................51
1.2.5.1. Safety Data ................................................................................51
1.2.5.2. PK Data .....................................................................................52
1.3. Rationale..................................................................................................................54
1.3.1. Study Rationale...........................................................................................54
1.3.1.1. Parts 1 and 2 ..............................................................................54
1.3.1.2. Part 3 .........................................................................................56
1.3.1.3. Parts 1, 2, and 3 .........................................................................57
1.3.2. Dose Rationale............................................................................................58
1.3.2.1. Part 1 .........................................................................................58
1.3.2.2. Part 2 .........................................................................................59
1.3.2.3. Part 3 .........................................................................................59
2. STUDY OBJECTIVES AND ENDPOINTS.......................................................................60
2.1. Objectives................................................................................................................60
2.1.1. Primary Objectives .....................................................................................60

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2.1.2. Secondary Objectives .................................................................................60
2.2. Endpoints.................................................................................................................61
2.2.1. Primary Endpoints ......................................................................................61
2.2.2. Secondary Endpoints ..................................................................................62
3. STUDY DESIGN.................................................................................................................64
3.1. Study Overview.......................................................................................................64
3.1.1. Part 1:..........................................................................................................65
3.1.2. Part 2:..........................................................................................................67
3.1.3. Part 3...........................................................................................................68
3.2. Dose Escalation and Stopping Rules (Part 1)..........................................................68
3.3. Dosing Criteria for Multiple Dose Cohorts (Part 1)................................................69
4. SUBJECT SELECTION......................................................................................................70
4.1. Inclusion and Exclusion Criteria.............................................................................70
4.1.1. Inclusion Criteria (Parts 1 and 2)................................................................70
4.1.1.1. Inclusion Criteria for Part 3 only...............................................72
4.1.2. Exclusion Criteria (Parts 1 and 2)...............................................................73
4.1.2.1. Exclusion Critieria Part 3 only..................................................77
4.2. Randomization Criteria ...........................................................................................82
4.3. Lifestyle Guidelines ................................................................................................82
4.3.1. Parts 1 and 2................................................................................................82
4.3.1.1. Meals and Dietary Restrictions .................................................82
4.3.1.2. Alcohol, Caffeine and Tobacco.................................................83
4.3.1.3. Activity......................................................................................83
4.3.1.4. Travel ........................................................................................83
4.3.1.5. Contraception ............................................................................83
4.3.2. Part 3...........................................................................................................85
4.3.2.1. Meals and Dietary Restrictions .................................................85
4.3.2.2. Alcohol, Caffeine and Tobacco.................................................85
4.3.2.3. Activity......................................................................................85
4.3.2.4. Contraception ............................................................................85
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4.3.2.5. Travel ........................................................................................87
4.3.2.6. Other..........................................................................................87
4.3.3. Rater Qualifications (Part 3).......................................................................87
4.4. Sponsor’s Qualified Medical Personnel..................................................................87
5. STUDY TREATMENTS.....................................................................................................88
5.1. Allocation to Treatment ..........................................................................................88
5.2. Breaking the Blind ..................................................................................................88
5.3. Subject Compliance.................................................................................................89
5.4. Investigational Product Supplies.............................................................................89
5.4.1. Dosage Form and Packaging ......................................................................89
5.4.2. Preparation and Dispensing........................................................................89
5.4.3. Administration............................................................................................89
5.5. Injection/Infusion Discontinuation..........................................................................89
5.6. Investigational Product Storage ..............................................................................90
5.7. Investigational Product Accountability...................................................................91
5.7.1. Destruction of Investigational Product Supplies ........................................91
5.8. Concomitant Treatment(s).......................................................................................91
5.8.1. Part 1...........................................................................................................91
5.8.2. Parts 1 and 2................................................................................................91
5.8.3. Part 3...........................................................................................................92
5.9. Prohibited Treatments and Medications during the Study......................................93
5.9.1. Part 2...........................................................................................................93
5.9.2. Part 3...........................................................................................................93
5.9.2.1. Rescue Medications...................................................................95
5.9.2.2. Vaccinations..............................................................................95
6. STUDY PROCEDURES .....................................................................................................95
6.1. Part 1/Part 2.............................................................................................................95
6.1.1. Screening ....................................................................................................95
6.1.2. Study Period................................................................................................98
6.1.2.1. Part 1 and Part 2: Day 0 ............................................................98
6.1.2.2. Part 1 and Part 2: Day 1 ..........................................................100
6.1.2.3. Part 1 and Part 2: Days 2, 3 and 4 ...........................................102

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6.1.2.4. Part 1 and Part 2: Day 5 ..........................................................103
6.1.2.5. Part 1 and Part 2: Days 8 and 15 .............................................104
6.1.2.6. Part 1 SAD and Part 2 Days 32 through Day 211...................105
6.1.2.7. Part 1: Multiple Dose Cohorts Day 31....................................107
6.1.2.8. Part 1: Multiple Dose Cohorts Day 32....................................108
6.1.2.9. Part 1: Multiple Dose Cohorts Days 33 and 34.......................110
6.1.2.10. Part 1 Multiple Dose Cohorts Days 46 through Day 241 .....111
6.1.2.11. Extended Follow-up (Part 1 and Part 2)................................112
6.1.2.12. Subject Withdrawal (Part 1 and Part 2).................................113
6.2. Part 3 .....................................................................................................................115
6.2.1. Screening ..................................................................................................116
6.2.2. Part 3 (Day 1, Day 29, Day 57, Day 85) – Dosing visits..........................118
6.2.3. Part 3 (Day 8)............................................................................................120
6.2.4. Part 3 (Day 113, Day 141, Day 169, Day 253, Day 337).........................121
6.2.5. Extended Follow-up..................................................................................122
6.2.6. Subject Withdrawal ..................................................................................123
6.2.7. End of Study (EOS)..................................................................................125
7. ASSESSMENTS................................................................................................................126
7.1. Part 1 and 2............................................................................................................126
7.1.1. Safety........................................................................................................126
7.1.1.1. Laboratory Tests......................................................................126
7.1.1.2. Pregnancy Testing (Part 2)......................................................128
7.1.1.3. Physical Examinations ............................................................128
7.1.1.4. Blood Pressure and Pulse Rate................................................128
7.1.1.5. Respiratory Rate......................................................................129
7.1.1.6. Temperature ............................................................................129
7.1.1.7. Electrocardiogram ...................................................................129
7.1.1.8. Continuous Cardiac Monitoring by Telemetry .......................130
7.1.1.9. Infusion and Injection Site Reaction Assessment ...................130
7.1.2. Pharmacokinetic, Immunogenicity,
 Samples......131
7.1.3. Pharmacokinetics (PK) for PF-06817024.................................................131
7.1.4. Immunogenicity........................................................................................131
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7.1.9. Blood Volume...........................................................................................135
7.1.9.1. Potential Cases of Acute Kidney Injury..................................137
7.1.16. Endoscopy (Part 2 only) .........................................................................139
7.2. Part 3 .....................................................................................................................140
7.2.1. Safety........................................................................................................140
7.2.1.1. Laboratory Tests......................................................................140
7.2.1.2. Pregnancy Testing...................................................................141
7.2.1.3. Physical Examinations ............................................................141
7.2.1.4. Blood Pressure and Pulse Rate................................................142
7.2.1.5. Respiratory Rate......................................................................142
7.2.1.6. Temperature ............................................................................142
7.2.1.7. Electrocardiogram ...................................................................142
7.2.1.8. Infusion and Injection Site Reaction Assessment ...................143
7.2.2. Pharmacokinetic, Immunogenicity, 
 
...........................................................................143
7.2.2.1. Pharmacokinetics (PK) for PF-06817024 ...............................144
7.2.2.2. Immunogenicity ......................................................................144
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7.2.5. Blood Volume...........................................................................................147
7.2.5.1. Potential Cases of Acute Kidney Injury..................................148
7.2.6. Atopic Dermatitis History.........................................................................148
7.2.7. Spirometry (subjects with a history of asthma only)................................149
7.2.8. Physician Assessments .............................................................................149
7.2.8.1. Fitzpatrick Skin Type Assessment ..........................................149
7.2.8.2. Eczema Area and Severity Index (EASI)63.............................149
7.2.8.4. Investigator Global Assessment (IGA)64.................................149
7.2.8.5. Columbia Suicide Severity Rating Scale (C-SSRS)66.............149
8. ADVERSE EVENT REPORTING....................................................................................151
8.1. Adverse Events......................................................................................................151
8.2. Reporting Period ...................................................................................................152
8.3. Definition of an Adverse Event.............................................................................152
8.4. Medication Errors..................................................................................................153
8.5. Abnormal Test Findings........................................................................................153
8.6. Serious Adverse Events.........................................................................................154
8.6.1. Protocol-Specified Serious Adverse Events.............................................154
8.6.2. Potential Cases of Drug-Induced Liver Injury..........................................154
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8.7. Hospitalization ......................................................................................................155
8.8. Severity Assessment..............................................................................................156
8.9. Causality Assessment............................................................................................157
8.10. Exposure During Pregnancy................................................................................157
8.11. Occupational Exposure .......................................................................................158
8.12. Withdrawal Due to Adverse Events (see also the section on Subject 
Withdrawal).............................................................................................................159
8.13. Eliciting Adverse Event Information ..................................................................159
8.14. Reporting Requirements......................................................................................159
8.14.1. Serious Adverse Event Reporting Requirements ...................................159
8.14.2. Nonserious Adverse Event Reporting Requirements .............................160
8.14.3. Sponsor’s Reporting Requirements to Regulatory Authorities ..............160
9. DATA ANALYSIS/STATISTICAL METHODS.............................................................160
9.1. Sample Size Determination...................................................................................160
9.2. Efficacy Analysis ..................................................................................................161
9.3. Pharmacokinetic Analysis.....................................................................................161
9.6. Safety Analysis......................................................................................................163
9.6.1. Electrocardiogram (ECG) Analysis..........................................................164
9.7. Interim Analysis ....................................................................................................164
9.8. Data Monitoring Committee .................................................................................165
10. QUALITY CONTROL AND QUALITY ASSURANCE...............................................165
11. DATA HANDLING AND RECORD KEEPING ...........................................................165
11.1. Case Report Forms/Data Collection Tools/Electronic Data Record...................165
11.2. Record Retention.................................................................................................166
12. ETHICS............................................................................................................................166
12.1. Institutional Review Board / Ethics Committee..................................................166
12.2. Ethical Conduct of the Study ..............................................................................167
12.3. Subject Information and Consent........................................................................167
12.4. Subject Recruitment ............................................................................................167
12.5. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH 
GCP .........................................................................................................................168
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13. DEFINITION OF END OF TRIAL.................................................................................168
13.1. End of Trial in United States...............................................................................168
14. SPONSOR DISCONTINUATION CRITERIA ..............................................................168
15. PUBLICATION OF STUDY RESULTS........................................................................168
15.1. Communication of Results by Pfizer ..................................................................168
15.2. Publications by Investigators ..............................................................................169
16. REFERENCES ................................................................................................................171
LIST OF TABLES
Table 1.
Summary of Serum PF-06817024 Pharmacokinetic Parameter Values 
Following Intravenous (IV) Infusion and Subcutaneous (SC) 
Administration, Study C0341001 (Preliminary Data)..........................................54
Table 2.
Predicted Human Exposure and Safety Margins Relative to Exposure 
Limits at Planned Dose Levels for Part 1 .............................................................58
Table 3.
Second Dose Prerequisites....................................................................................70
Table 4.
Laboratory Tests .................................................................................................127
Table 5.
Blood Volume for Part 1.....................................................................................136
Table 6.
Blood Volume for Part 2.....................................................................................137
Table 7.
Laboratory Tests .................................................................................................140
Table 8.
Blood Volume for Part 3.....................................................................................148
Table 9.
Definition of PK Parameters in Study C0341001...............................................161
Table 10.
Clinical Sign Severity Scoring Criteria for the Eczema Area and Severity 
Index (EASI).......................................................................................................188
Table 11.
Handprint Determination of Body Region Surface Area (BSA)........................189
Table 12.
Eczema Area and Severity Index (EASI) Area Score Criteria...........................189
Table 13.
Eczema Area and Severity Index (EASI) Body Region Weighting...................189
LIST OF FIGURES
Figure 1.
Study Design Schematic.......................................................................................65
Figure 2.
Study Design Schematic for Part 3.......................................................................65

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APPENDICES
 
Appendix 5. Abbreviations....................................................................................................182
Appendix 6. Clinical Criteria for Diagnosing Anaphylaxis Guidance50................................186
Appendix 7. Fitzpatrick Skin Type........................................................................................187
Appendix 8. EASI..................................................................................................................188
Appendix 10. Investigator Global Assessment (IGA) Score.................................................193
Appendix 15. Columbia Suicide Severity Rating Scale (C-SSRS) .......................................198
Appendix 16. Diagnostic Criteria for Atopic Dermatitis.......................................................201
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SCHEDULE OF ACTIVITIES
The schedule of activities table provides an overview of the protocol visits and procedures.  Refer to the STUDY PROCEDURES and
ASSESSMENTS sections of the protocol for detailed information on each procedure and assessment required for compliance with the
protocol.
The investigator may schedule visits (unplanned visits) in addition to those listed on the schedule of activities, in order to conduct
evaluations or assessments required to protect the well-being of the subject.
Table A: Part 1, Healthy Subjects Who May be Mildly Atopic Screening through Day 15
Protocol Activity
Screen
Clinical Confinement
Follow-up 
Visit
Study Day
-27 to
-1
Day 0
Day 1q
Day 2 Day 3 Day
4
Day
5
Day
8
Day
15
Visit Window
-2 hrs to
-5 min
0hr
.5 hr
1hra
2hr
4hr
8hr
12hr
24hr 48hr 72hr 96hr
1 
day
3
days
Enrollment Procedures
Informed Consent
X
Demography
X
Medical History
X
Xb
History of Drug, Alcohol and Tobacco use
X
Xb
Inclusion/Exclusion Criteria
X
Xb
Medical Procedures
Physical Examinationc
X
X
X
X
X
Weight
X
X
X
X
X
Height
X
Chest X-rayd
X
Vital Signs: supine BP, PR & oral temperature
X
Xe
X
X
X
X
X
X
X
X
X
X
X
X
X
Vital Sign: Respiratory Rate (RR)
X
X
X
X
X
X
X
X
Single 12-lead Electrocardiogram (ECG)
X
Triplicate 12-lead Electrocardiogram (ECG)f
X
X
X
X
X
X
X
X
X
Insert IV catheter for blood collectiong
X
Insert IV catheter for study drug infusionh
X
Telemetryi
X






Laboratory Assessments
Urine Drug Test and Alcohol Breath Testj
X
X
HIV, HBsAg, HBcAb, HCVAb, HBsAbr
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Protocol Activity
Screen
Clinical Confinement
Follow-up 
Visit
Study Day
-27 to
-1
Day 0
Day 1q
Day 2 Day 3 Day
4
Day
5
Day
8
Day
15
Visit Window
-2 hrs to
-5 min
0hr
.5 hr
1hra
2hr
4hr
8hr
12hr
24hr 48hr 72hr 96hr
±1 
day
±3
days
QuantiFERON – Tuberculosis (TB) Gold Test
X
Phadiatopk
X
Follicle Stimulating Hormone (FSH)l
X
Safety Laboratory: Hematology, Chemistry, Urinalysis 
(UA)
X
Xm
X
X
X
X
X
X
Serum Pharmacokinetic (PK) 
X
X
X
X
X
X
X
X
X
X
X
X
Serum IgEo
X
X
Immunogenicity (ADA, NAb)
X
X
Trial Treatment Procedures
Admission to Clinical Research Unit (CRU)
X
Study Treatment Administration
X
Infusion/Injection Site Reaction
Xp
Xp
X
X
X
X
X
X
X
X
Discharge from Clinical Research Unit
X
Contraception Check
X
X
X
X
X
Adverse Event Monitorings
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
Prior/Concomitant Treatment
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
Abbreviations: →= ongoing/continuous event; ADA = antidrug antibody; BP = blood pressure; CRU = clinical research unit;
; ECG = electrocardiogram;
 FSH = follicle-stimulating
hormone; HCVAb =Hepatitis C Virus Antibodies; HBcAb = Hepatitis B Core Antibody; HBsAb = Hepatitis B Surface Antigen; HBsAg = Hepatitis B Surface 
Antigen; HIV = human immunodeficiency virus; IgE = Immunoglobulin E; 
;
; 
IV = intravenous; NAb = neutralizing antibody; PK = pharmacokinetic; PR = pulse rate; 
 RR = respiratory rate; SAD = Single Ascending 
Dose; 
 TB = tuberculosis; UA = urinalysis.
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a.
The 1 hour post-dose procedures are to be implemented for all cohorts (IV and subcutaneous [SC]) as close to 1 hour as possible. For the IV Cohorts, 
procedures are to occur after investigational product infusion is completed (see Dosage and Administration Instructions (DAI)). ECG and vital sign 
procedures may be collected up to 10 minutes prior to investigational product infusion completion. 
b.
Updated since screening. 
c.
A full physical examination may be done at screening or may be deferred to Day 0 at the discretion of the principal investigator (PI).  If a full physical exam 
is performed at screening, a limited physical exam will be performed on Day 0. Full physical examinations are required prior to dosing (screening or Day 0) 
and at the final study visit.  A limited physical examination will be completed at all other times specified in the SoA.  A full physical examination may also
be performed at the discretion of the investigator at a follow-up visit if there is a new or open AE.
d.
Chest X-ray results within 3 months of the screening visit otherwise a chest x-ray must be performed and results obtained prior to randomization.
e.
On Day 0, oral temperature is the only vital sign collection required.
f.
ECGs will be collected in triplicate approximately 2-4 minutes apart. 
g.
Site may insert IV catheter for blood sample collection up to 24 hours prior to study drug administration.  IV catheter should be inserted in the extremity
contra lateral to that into which test article will be administered.  Heparin is not to be utilized.
h.
IV cohorts only, after all pre-dose procedures have been completed, insert IV catheter for study drug.
i.
To establish a baseline, telemetry should be recorded for at least 2 hours before dosing.  This may be done 2-hours immediately prior to dosing or at some
2-hour continuous interval in the 24 hours prior to dosing, as long as the recording is performed when the subject is awake.  Continuous cardiac monitoring
will be conducted approximately -5 minutes pre-dose through the 8 hour post-dose period.
j.
Subjects may undergo a urine drug test at the discretion of the investigator at any time during the study.  An alcohol breath test is not mandatory but may be 
given at Screening or any other time during the study at the discretion of the investigator. 
k.
Phadiatop historical positive test result with appropriate documentation is acceptable for Cohorts 1-4 only. Starting with Cohort 5 and later, Phadiatop is to 
be collected prior to dosing. 
l.
Serum FSH for all females who are amenorrheic for at least 12 consecutive months.
m. The results must have no clinically significant findings, as judged by the investigator, in order for a subject to be dosed on Day 1.
o.
IgE results within 6 months of the screening visit otherwise an IgE test must be performed and results obtained prior to randomization for Cohorts 1-4 only.
Starting with Cohort 5 and later, at least two (2) IgE pre-dose collections are to occur. 
p.
Subjects will be continuously monitored for infusion site reactions (for IV administration) from start of drug administration until the end of infusion. 
Injection site reactions (for SC administrations) should be monitored continuously for the first 30 minutes and then at time points indicated in the SoA.
q.
If any intravenous infusion time exceeds 100 minutes, the post-dose time points for Day 1 (through 24 hours) will shift out relative to the end of infusion.
r.
HBsAb test if screening results for HBsAg are negative and HBcAb are positive for Part 1 (Cohort 5 and later).
s.
See Appendix 6: Clinical Criteria for Diagnosing Anaphylaxis Guidance to assist with identifying cases of potential anaphylaxis while monitoring for 
adverse events. Any signs or symptoms of anaphylaxis should be treated according to the Investigator’s standard of care and reported as an adverse event. 
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Table B: Part 1, Healthy Subjects Who May be Mildly Atopic, Single Dose Cohorts Day 32 through Day 211a (Cohorts 1, 2 and 
6, and Cohorts 3 through 5 and 7 if NOT Rolled Over Into Multiple Dosing Portion of Study)d
Protocol Activity
Follow-up Visits
Extended 
Follow-upa
Study Day
Day
32
Day
46
Day
61
Day 
91
Day 
121
Day 
151
Day 
181
Day 
211
Visit Window
±3
days
±5
days
±5
days
±7 
days
±7 
days
±7 
days
±7 
days
±7 
days
±14 days
Medical Procedures
Physical Examinationb
X
X
X
X
X
X
X
X
X
Weight
X
X
X
X
X
X
X
X
Vital Signs (supine BP, PR, RR, and oral temperature)
X
X
X
X
X
X
X
X
Single 12-lead Electrocardiogram (ECG)
X
X
X
X
X
X
X
Laboratory Assessments
Urine Drug and Alcohol Breath Testc
Safety Laboratory: Hematology, Chemistry, Urinalysis (UA) 
X
X
X
X
X
X
X
X
Serum Pharmacokinetic (PK) 
X
X
X
X
X
X
X
X
X
Immunogenicity (ADA, NAb)
X
X
X
X
X
X
X
X
X
Trial Treatment Procedures
Contraception check 
X
X
X
X
X
X
X
X
X
Adverse Event Monitoring
→
→
→
→
→
→
→
→
→
Prior/Concomitant Treatment
→
→
→
→
→
→
→
→
→
Discharge from Study 
X
X
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Abbreviations: →= ongoing/continuous event; ADA = antidrug antibody; BP = blood pressure;
 
 ECG = electrocardiogram;
 IV = intravenous; NAb = neutralizing antibody; PK = pharmacokinetic; PR = pulse rate; 
 RR = respiratory rate; 
 UA = urinalysis
a.
Extended follow-up visits: Subjects having an unresolved adverse event that is possibly related to ADA immune response will be asked to return for 
extended follow-up visit(s) at up to 3 month intervals beyond the last follow-up visit for up to 12 months after last drug administration or until the adverse 
event or its sequelae resolve or stabilize at a level acceptable to the investigator and Sponsor concurs with the investigator’s assessment. Subjects may also 
be required to attend extended follow-up visits if the emerging data project that half-life is longer than approximately 41 days. Under these circumstances, 
subjects will be asked to return for extended follow-up visit(s) at up to 3 month intervals beyond the last follow-up visit to cover approximately ≥5 times the 
observed half-life 
 
 
 OR of sufficient duration to have projected exposures decrease below ADA drug tolerance 
. Safety labs for extended follow-up visits may be done at the discretion of the 
PI for cohorts currently in the study.
b.
Full physical examination is required at the final study visit. A limited physical examination will be completed at all other times specified in the SoA. A
full physical examination may also be performed at the discretion of the investigator at a follow-up visit if there is a new or open AE.
c.
Subjects may undergo a urine drug test and/or alcohol breath test at any time during the study at the discretion of the investigator.
d.
If a subject from Cohorts 3-5, 7, or 10-12 cannot receive a second dose within the allotted time due to unexpected circumstances (eg, scheduling), they 
should follow SoA Table B through the end of the study.
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Table C: Part 1, Healthy Subjects Who May be Mildly Atopic, Cohorts Receiving Multiple Doses Day 31 through Day 241b
(Cohorts 3 through 5 and 7 if Rolled Over Into Multiple Dose Portion of Study; Cohorts 10 through 12 if Cohorts 3 through 5
were NOT Rolled Over Into Multiple Dose Portion of Study)a
Protocol Activity
Clinical Confinement
Follow-up Visit
Extended 
Follow-upb
Study Day
Day
31
Day 32l
Day
33
Day
34
Day
46
Day 
61
Day 
91
Day 
121
Day 
151
Day 
181
Day 
211
Day 
241
Visit Window
-2hrs
to
-5min
0hr .5 hr 1hrc
2hr
4hr
8hr 12hr 24hr 48hr
±5
day
±5
day
±7 
days
±7 
days
±7 
days
±7 
days
±7 
days
±7 
days
±14 days
Medical Procedures
Physical Examinationd
X
X
X
X
X
X
X
X
X
X
X
Weight
X
X
X
X
X
X
X
X
X
X
Vital Signs (supine BP, PR, RR, and 
oral temperature)e
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Triplicate 12-lead ECGf
X
X
X
X
X
Single 12-lead ECG
X
X
X
X
X
X
X
X
X
Insert IV catheter for blood collectiong
X
Insert IV catheter for study drug 
infusionh
X
Telemetryi
X
→
→
→
→
→
→
Laboratory Assessments
Urine Drug and Alcohol Breath Testj
X
Safety Laboratory: Hematology,
Chemistry, Urinalysis (UA) 
X
X
X
X
X
X
X
X
X
X
X
Serum Pharmacokinetic (PK) 
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Immunogenicity (ADA, NAb)
X
X
X
X
X
X
X
X
X
X
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Protocol Activity
Clinical Confinement
Follow-up Visit
Extended 
Follow-upb
Study Day
Day
31
Day 32l
Day
33
Day
34
Day
46
Day 
61
Day 
91
Day 
121
Day 
151
Day 
181
Day 
211
Day 
241
Visit Window
-2hrs
to
-5min
0hr .5 hr 1hrc
2hr
4hr
8hr 12hr 24hr 48hr
±5
day
±5
day
±7 
days
±7 
days
±7 
days
±7 
days
±7 
days
±7 
days
±14 days
Trial Treatment Procedures 
Contraception Check
X
X
X
X
X
X
X
X
X
X
Admission to CRU
X
Study Treatment Administration
X
Assess Injection/Infusion Site Reactionk
X
X
X
X
X
X
X
X
Discharge from CRU
X
Adverse Event Monitoringm
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
Prior/Concomitant Treatment
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
Discharge from Study
X
X
Abbreviations: →= ongoing/continuous event; ADA = antidrug antibody; BP = blood pressure;
 
 CRU = clinical research unit; ECG = electrocardiogram;
 
 IV = intravenous; NAb = neutralizing antibody; PK = pharmacokinetic; 
PR = pulse rate; 
 RR = respiratory rate; 
 UA = urinalysis
a.
Second dose will occur at a minimum of 4 weeks and at a maximum of 12 weeks after the first dose and after protocol required safety and PK review (see 
Section 3.3).  If subjects are not admitted into the clinic for the second dose by Day 35 (Day 32+3 days), subjects should follow SoA Table B Day 32 
follow-up visit; if subjects are not admitted into the clinic for the second dose by Day 51 (Day 46+5 days), subjects should follow SoA Table B Day 32 and 
Day 46 follow-up visits; if subjects are not admitted into the clinic for the second dose by Day 66 (Day 61 +5 days), subjects should follow SoA Table B
Day 32, Day 46 and Day 61 follow-up visits. SoA Table C visits would then shift out accordingly (by days of delay for each cohort/subjects affected) 
ensuring 7 months of follow-up after the second dose.  If a subject cannot receive a second dose within the allotted time due to unexpected circumstances 
(eg, scheduling), they should follow SoA Table B through the end of the study.
b.
Extended follow-up visits: Subjects having an unresolved adverse event that is possibly related to ADA immune response will be asked to return for 
extended follow-up visit(s) at up to 3 month intervals beyond the last follow-up visit for up to 12 months after last drug administration or until the adverse 
event or its sequelae resolve or stabilize at a level acceptable to the investigator and Sponsor concurs with the investigator’s assessment. Subjects may also 
be required to attend extended follow-up visits if the emerging data project that half-life is longer than approximately 41 days. Under these circumstances, 
subjects will be asked to return for extended follow-up visit(s) at up to 3 month intervals beyond the last follow-up visit to cover approximately ≥5 times the 
observed half-life 
 
 
 OR of sufficient duration to have projected exposures decrease below ADA drug tolerance 
 
Safety labs for extended follow-up visits may be done at the discretion of the PI 
for cohorts currently in the study.
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c.
The 1 hour post-dose procedures are to be implemented for all cohorts (IV and subcutaneous [SC]) as close to 1 hour as possible. For the IV Cohorts,
procedures are to occur after investigational product infusion is completed (see DAI). ECG and vital sign procedures may be collected up to 10 minutes 
prior to investigational product infusion completion.
d.
Full physical examinations are required at final study visit. A limited physical examination will be completed at all other times specified in the SOA.  A full 
physical examination may also be performed at the discretion of the investigator at a follow-up visit if there is a new or open AE.
e.
Vitals signs include BP, PR, RR, and oral temperature. RR is to be collected at Day 32 prior to dosing (up to 2 hours prior), daily during confinement, and at 
all follow-up visits.
f.
ECGs will be collected in triplicate approximately 2-4 minutes apart.
g.
Site may insert IV catheter for blood sample collection up to 24 hours prior to study drug administration.  IV catheter should be inserted in the extremity
contra lateral to that into which test article will be administered.  Heparin is not to be utilized.
h.
After all pre-dose procedures have been completed, insert IV catheter for study drug infusion for IV administration only.
i.
Telemetry may be collected after study team and investigator review safety data required prior to initiating multiple dosing per protocol Section 3.1.
j.
Subjects may undergo a urine drug test and/or an alcohol breath test at any time during the study at the discretion of the investigator. 
k.
Subjects will be continuously monitored for infusion site reactions (for IV administration) from start of drug administration until the end of infusion.
Injection site reactions (for SC administrations) should be monitored continuously for the first 30 minutes and then at time points indicated in the SOA. 
l.
If any intravenous infusion time exceeds 100 minutes, the post-dose time points for Day 32 (through 24 hours) will shift out relative to the end of infusion.
m. See Appendix 6: Clinical Criteria for Diagnosing Anaphylaxis Guidance to assist with identifying cases of potential anaphylaxis while monitoring for 
adverse events. Any signs or symptoms of anaphylaxis should be treated according to the Investigator’s standard of care and reported as an adverse event.

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Table D: Part 2, Chronic Rhinosinusitis with Nasal Polyps Patient Cohorts (Cohort 8 and 9)a
Protocol Activity
Screen
Clinical Confinement
Follow-up Visit
Extended 
Follow-upa
Study Day
-27 to
-1
Day
0w
Day 1s
Day
2
Day
5
Day
8
Day
15
Day
32
Day
61
Day 
91
Day 
121
Day 
181
Day 
211
Visit Window
-2hrs
to
-5min
0hr
.5 
hr
1hrb
2hr 4hr 8hr 12hr 24hr 96hr
±1 
day
±3
days
±3
days
±5
days
±7 
days
±7 
days
±7 
days
±7 
days
±14 days
Enrollment Procedures
Informed Consent
X
Demography
X
Medical History
X
Xc
History of Drug, Alcohol and
Tobacco use
X
Xc
Inclusion/Exclusion Criteria
X
Xc
Medical Procedures
Physical Examinationd
X
X
X
X
X
X
X
X
X
X
X
X
X
Weight
X
X
X
X
X
X
X
X
X
X
X
X
Height
X
Chest X-raye
X
Spirometryf
X
Nasal Endoscopy and Nasal Polyp 
Score (NPS)
Xg
Xg
Vital Signs: supine BP, PR & oral 
temperature
X
Xh
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Vital Sign: Respiratory Rate (RR)
X
X
X
X
X
X
X
X
X
X
X
X
Single 12-lead ECG
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Insert IV catheter for blood 
collectioni
X
Insert IV catheter for study drug 
infusionj
X
Telemetryk
X
→
→
→
→
→
→
Laboratory Assessments
Urine Drug Test and Alcohol Breath 
Testl
X
X
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Protocol Activity
Screen
Clinical Confinement
Follow-up Visit
Extended 
Follow-upa
Study Day
-27 to
-1
Day
0w
Day 1s
Day
2
Day
5
Day
8
Day
15
Day
32
Day
61
Day 
91
Day 
121
Day 
181
Day 
211
Visit Window
-2hrs
to
-5min
0hr
.5 
hr
1hrb
2hr 4hr 8hr 12hr 24hr 96hr
±1 
day
±3
days
±3
days
±5
days
±7 
days
±7 
days
±7 
days
±7 
days
±14 days
HIV, HBsAg, HBcAb, HCVAb, 
HBsAbt
X
QuantiFERON – Tuberculosis (TB) 
Gold Test
X
Follicle Stimulating Hormone 
(FSH)m
X
Pregnancy Testn
X
X
X
X
X
X
X
X
X
X
X
X
Safety Laboratory: Hematology,
Chemistry, Urinalysis (UA)
X
Xo
X
X
X
X
X
X
X
X
X
X
Serum Pharmacokinetic (PK) 
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Immunogenicity (ADA, NAb)
X
X
X
X
X
X
X
X
X
Assessments
Trial Treatment Procedures
Admission to CRU
X
Study Treatment Administration
X
Infusion Site Reactionr
X
X
X
X
X
X
X
X
Discharge from CRU
X
Contraception Check 
X
X
X
X
X
X
X
X
X
X
X
X
X
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Protocol Activity
Screen
Clinical Confinement
Follow-up Visit
Extended 
Follow-upa
Study Day
-27 to
-1
Day
0w
Day 1s
Day
2
Day
5
Day
8
Day
15
Day
32
Day
61
Day 
91
Day 
121
Day 
181
Day 
211
Visit Window
-2hrs
to
-5min
0hr
.5 
hr
1hrb
2hr 4hr 8hr 12hr 24hr 96hr
±1 
day
±3
days
±3
days
±5
days
±7 
days
±7 
days
±7 
days
±7 
days
±14 days
Adverse Event Monitoringv
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
Prior/Concomitant Treatment
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
Discharge from Study
X
X
Abbreviations: →= ongoing/continuous event;
 ADA = antidrug antibody; BP = blood pressure;
CRU = clinical research unit; CT = computerized axial 
tomography; ECG = electrocardiogram;
FSH = follicle-stimulating hormone; HCVAb = Hepatitis C Virus Antibodies; 
HBcAb = Hepatitis B Core Antibody; HBsAb = Hepatitis B Surface Antibody; HBsAg = Hepatitis B Surface Antigen; HIV = human immunodeficiency virus; 
 IV = intravenous; NAb = neutralizing antibody; 
PK = pharmacokinetic; PR = pulse rate; 
 RR = respiratory rate; 
 
 TB = tuberculosis; UA = urinalysis; 
.
a.
Extended follow-up visits: Subjects having an unresolved adverse event that is possibly related to ADA immune response will be asked to return for 
extended follow-up visit(s) at up to 3 month intervals beyond the last follow-up visit for up to 12 months after last drug administration or until the adverse 
event or its sequelae resolve or stabilize at a level acceptable to the investigator and Sponsor concurs with the investigator’s assessment. Subjects may also 
be required to attend extended follow-up visits if the emerging data project that half-life is longer than approximately 41 days. Under these circumstances, 
subjects will be asked to return for extended follow-up visit(s) at up to 3 month intervals beyond the last follow-up visit to cover approximately ≥5 times the 
observed half-life 
 
 
 OR of sufficient duration to have projected exposures decrease below ADA drug tolerance 
 
. Safety labs for extended follow-up visits may be done at the discretion of the PI 
for cohorts currently in the study.
b.
The 1 hour post-dose procedures are to be implemented as close to 1-hour as possible. For the IV Cohorts, procedures are to occur after investigational 
product infusion is completed (see DAI). ECG and vital sign procedures may be collected up to 10 minutes prior to investigational product infusion 
completion.
c.
Updated since screening. 
d.
A full physical examination may be done at screening or may be deferred to Day 0 at the discretion of the principal investigator (PI).  If a full physical exam 
is performed at screening, a limited physical exam will be performed on Day 0. Full physical examinations are required prior to dosing (screening or Day 0) 
and at the final study visit. A limited physical examination will be completed at all other times specified in the SoA.  A full physical examination may also 
be performed at the discretion of the investigator at a follow-up visit if there is a new or open AE. 
e.
Chest X-ray results within 3 months of the screening visit otherwise a chest x-ray must be performed and results obtained prior to randomization.
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f.
Spirometry required for subjects with a history of asthma. Spirometry results acceptable within 3 months of screening visit otherwise a spirometry must be 
performed and results obtained prior to randomization. 
g.
The screening nasal endoscopy including assessment of Nasal Polyp Score (NPS) is to be completed after all other screening criteria have been verified. If a
subject is eligible for the study, they will undergo nasal endoscopy including assessment of NPS, and CT scan to assess the Lund-Mackay CT score, ideally 
on Day 0. However, the baseline NPS and Lund-Mackay CT score may be determined up to 5 days prior to Day 0. Thus, if a subject is screened and found 
eligible for the study based on NPS no more than 5 days prior to Day 0, the NPS from screening may be used as the Day 0 NPS. The baseline/Day 0 CT 
scan cannot be completed until it has been determined the subject is eligible for the study regardless of when the CT scan occurs. 
h.
On Day 0, oral temperature is the only vital sign collection required.
i.
Site may insert IV catheter for blood sample collection up to 24 hours prior to study drug administration.  IV catheter should be inserted in the extremity 
contra lateral to that into which test article will be administered.  Heparin is not to be utilized.
j.
After all pre-dose procedures have been completed, insert IV catheter for study drug infusion for IV administration only.
k.
To establish a baseline, telemetry should be recorded for at least 2 hours before dosing.  This may be done 2-hours immediately prior to dosing or at some 
2-hour continuous interval in the 24 hours prior to dosing, as long as the recording is performed when the subject is awake.  Continuous cardiac monitoring 
will be conducted approximately-5 minutes pre-dose through the 8 hour post-dose period.
l.
Subjects may undergo a urine drug test at the discretion of the investigator at any time during the study. An alcohol breath test is not mandatory but may be 
given at Screening or any other time during the study at the discretion of the investigator.
m. Serum FSH for all females who are amenorrheic for at least 12 consecutive months.
n.
To be completed for female subjects of childbearing potential with either documented bilateral tubal ligation or bilateral salpingectomy-see Section 7.1.1.2.
o.
The results must have no clinically significant findings, as judged by the investigator, in order for a subject to be dosed on Day 1.
r.
Subjects will be continuously monitored for infusion site reactions (for IV administration) from start of drug administration until the end of infusion. 
s.
If any intravenous infusion time exceeds 100 minutes, the post-dose time points for Day 1 (through 24 hours) will shift out relative to the end of infusion.
t.
HBsAb test if screening results for HBsAg are negative and HBcAb are positive.
v.
See Appendix 6: Clinical Criteria for Diagnosing Anaphylaxis Guidance to assist with identifying cases of potential anaphylaxis while monitoring for 
adverse events. Any signs or symptoms of anaphylaxis should be treated according to the Investigator’s standard of care and reported as an adverse event.
w.
Day 0 may be an outpatient visit (at the discretion of the investigator). If Day 0 is an outpatient visit, the subject should be carefully instructed about fasting, 
avoidance of dietary/alcohol indiscretions, and avoidance of strenuous exercise. Additional baseline safety laboratory samples will need to be collected at 
Day 1 (-2 hours to -5 minutes).
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Table E: Part 3, Moderate to Severe Atopic Dermatitis Subject Cohort (Cohort 13)
Study Day
Screening: 
Day -41 to 
Day 0
Day 1c,dd
/ Week 0
Day
8/
Week 1
Day 29c,dd/
Week 4
Day 57c,dd/
Week 8
Visit Windowy
2 days
3 days
3 days
Time
Pre-doseb
0 hr
1.5 hd
Pre-doseb
0 hr
1.5 hd
Pre-doseb
0 hr
1.5 hd
Enrollment Procedures
Informed Consent
X
Demography
X
Medical History
X
Xe
Atopic Dermatitis History including 
other atopic diseases 
X
Xe
History of illegal Drug, Alcohol and 
Tobacco use
X
Xe
Inclusion/Exclusion Criteria
X
Xe
Medical Procedures
Physical Examinationf
X
X
X
X
X
Weight
X
X
X
X
Height
X
Chest X-rayg
X
Spirometryh
X
Vital Signs: supine BP, PR & 
temperature
X
Xp
X
X
Xp
X
Xp
X
Vital Sign: Respiratory Rate (RR)
Xp
Xaa
Xp
Xaa
Xp
Xaa
Single 12-lead ECG
X
Xp
X
Xp
X
Xp
X
Insert IV catheter for blood 
collectionj
X
X
X
Insert IV catheter for study drug 
infusionk
X
X
X
Laboratory Assessments
Urine Drug Test and Alcohol Breath 
Testl
X
X
HIV, HBsAg, HBcAb, HCVAb, 
HBsAbm
X
QuantiFERON – Tuberculosis (TB) 
Gold Test
X
Follicle Stimulating Hormone 
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Study Day
Screening: 
Day -41 to 
Day 0
Day 1c,dd
/ Week 0
Day
8/
Week 1
Day 29c,dd/
Week 4
Day 57c,dd/
Week 8
Visit Windowy
±2 days
±3 days
±3 days
Time
Pre-doseb
0 hr
1.5 hd
Pre-doseb
0 hr
1.5 hd
Pre-doseb
0 hr
1.5 hd
(FSH)n
Pregnancy Testo
X
X
X
X
X
Safety Laboratory: Hematology, 
Chemistry, Urinalysis (UA)
X
X
X
X
X
Immunogenicity (ADA, NAb)
X
X
X
X
 
 
Physician Assessments of Disease 
Activity
Fitzpatrick Skin Type Assessment
X
Eczema Area and Severity Index 
(EASI)
X
X
 
Investigator’s Global Assessment 
(IGA)
X
X
 
 
 
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Study Day
Screening: 
Day -41 to 
Day 0
Day 1c,dd
/ Week 0
Day
8/
Week 1
Day 29c,dd/
Week 4
Day 57c,dd/
Week 8
Visit Windowy
±2 days
±3 days
±3 days
Time
Pre-doseb
0 hr
1.5 hd
Pre-doseb
0 hr
1.5 hd
Pre-doseb
0 hr
1.5 hd
 
 
Trial Treatment Procedures
Study Treatment Administration
X
X
X
Assessment for Infusion Site 
Reactionu
X
X
X
X
X
X
Other study activities
Contraception Checki
X
X
X
X
X
Adverse Event Monitoringv
X
X
→
X
X
X
→
X
X
→
X
Prior/Concomitant Treatment
X
X
→
X
→
→
→
X
→
→
X
Discharge from Studyt
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CONTINUATION OF TABLE E
Study Day
Day 85/
Week 12c,dd
Day 113/
Week 16
Day 141
/Week 20
FU
Day169 
/Week 24
FU
Day 253/
Week 36
FU
Day 337/
Week 48
FU
Extended 
FUa
EW
EOSbb
Visit Windowy
±3 days
±3 days
±7 days
±7 days
±7 days
±7 days
±7 days
Time
Pre-doseb
0 hr
1.5 hd
Medical Procedures
Physical Examinationf
X
X
X
X
X
X
X
X
X
Weight
X
X
X
X
X
X
X
X
Vital Signs: supine BP, PR 
&temperature
Xp
X
X
X
X
X
X
X
Xcc
Xcc
Vital Sign: Respiratory Rate (RR)
Xp
Xaa
Single 12-lead ECG
Xp
X
X
X
X
Xz
Insert IV catheter for blood 
collectionj
X
Insert IV catheter for study drug 
infusionk
X
Laboratory Assessments
Pregnancy Testo
X
X
X
X
X
X
X
X
X
Safety Laboratory: Hematology, 
Chemistry, Urinalysis (UA)
X
X
X
X
X
X
X
Immunogenicity (ADA, NAb)
X
X
X
X
X
X
X
 
 
 
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Study Day
Day 85/
Week 12c,dd
Day 113/
Week 16
Day 141
/Week 20
FU
Day169 
/Week 24
FU
Day 253/
Week 36
FU
Day 337/
Week 48
FU
Extended 
FUa
EW
EOSbb
Visit Windowy
±3 days
±3 days
±7 days
±7 days
±7 days
±7 days
±7 days
Time
Pre-doseb
0 hr
1.5 hd
Physician Assessments of 
Disease Activity
 
 
 
 
 
 
 
 
Trial Treatment Procedures
Study Treatment Administration
X
Infusion Site Reactionu
X
X
Additional study activities
Contraception Checki
X
X
X
X
X
X
X
X
X
Adverse Event Monitoringv
X
→
X
X
X
X
X
X
X
X
X
Concomitant Treatment
→
→
X
→
→
→
→
→
→
X
X
Discharge from Studyt
X
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Abbreviations: →= ongoing/continuous event; 
 ADA = antidrug antibody; BP = blood pressure; 
CRU = clinical research unit; 
 
 
CT = computerized axial tomography; 
ECG = electrocardiogram; EW = Early Withdrawal; FSH = follicle-stimulating hormone; 
 
HCVAb = Hepatitis C Virus Antibodies; HBcAb = Hepatitis B Core Antibody; HBsAb = Hepatitis B Surface Antibody; HBsAg = Hepatitis B Surface Antigen; 
HIV = human immunodeficiency virus;
 
 
IV = intravenous; NAb = neutralizing antibody;
PR = pulse rate; RR = respiratory Rate; 
 TB = tuberculosis; UA = urinalysis.
a.
Extended follow-up visits: Subjects having an unresolved adverse event that is possibly related to ADA immune response will be asked to return for 
extended follow-up visit(s) at up to 3 month intervals beyond the last follow-up visit for up to 12 months after last drug administration OR until the adverse 
event (or its sequelae) resolve (or stabilize) at a level acceptable to the investigator and sponsor concurs with the investigator’s assessment. Subjects will be 
followed for at least 1 year after the last dose (at Week 12), which is ≥3 times the preliminary estimated half-life of approximately 90 days and 
>80% exposure (AUC) based on emerging data for the earlier cohorts of healthy subjects, which is adequate to estimate the elimination half-life.  Subjects 
may also be required to attend extended follow-up visit(s) if the emerging data project pharmacologically relevant exposure will extend significantly longer 
than 1 year.  Under these circumstances, subjects will be asked to return for extended follow-up visit(s) at up to 3 month intervals beyond the last planned 
regular visit to cover approximately ≥5 times the observed half-life 
 
 
 OR of sufficient duration to have projected exposures decrease below ADA drug tolerance 
 
b.
Pre-dose activities on Day 1, Day 29, Day 57, Day 85 may be performed, at the discretion of the investigator, on the day preceding each dosing visit (ie, on 
Day 0, Day 28, Day 56, Day 84) as inpatient in clinical site or outpatient. These include medical history, atopic dermatitis history including atopic disease 
history, history of illegal drug, alcohol and tobacco use, inclusion/exclusion criteria, physical examination, weight, urine drug test and alcohol breath test, 
pregnancy test, safety laboratory (hematology, chemistry, urinalysis),
 
clinical assessments (Fitzpatrick skin type, EASI, 
, IGA), 
 
 
 
 
 For dosing visits performed as outpatient visits, the subject should be carefully instructed about fasting, 
avoidance of dietary/alcohol indiscretions, and avoidance of strenuous exercise. See Section 4.3.2. Pre-dose vitals and ECG measurements will be recorded 
as 0 hr measurements. Pre-dose samples collected for PK, Immunogenicity, 
 will be recorded as 0 hr samples. Pre-dose 
safety labs for the purposes of Inclusion/Exclusion criteria may be done 2 days prior to dosing on Day 1.
c.
If any intravenous infusion time exceeds 1.5 hour, the post-dose (1.5 hour) time points for the visits at which subject receives IP will shift out relative to the 
end of infusion and will be done after the infusion of the IP is completed. The actual times need to be documented in the CRF.
d.
The 1.5 hour post-dose procedures are to be implemented as close to 1.5 hours after the start of the infusion as possible but after the infusion of the IP is 
completed. Procedures are to occur after investigational product infusion is completed (see DAI).
e.
Updated since screening. 
f.
A full physical examination may be done at screening or may be deferred to Day 1 at the discretion of the principal investigator (PI).  If a full physical exam 
is performed at screening, a limited physical exam will be performed on Day 1.  Full physical examinations are also required at the final study visit and early 
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withdrawal visit.  A full physical examination may also be performed at the discretion of the investigator at a follow-up visit if there is a new or open AE. A 
limited physical examination will be completed at all other times specified in the SoA. 
g.
Chest X-ray results within 3 months of the screening visit otherwise a chest x-ray (standard posterior-anterior and lateral views) must be performed and 
results obtained prior to randomization.
h.
Spirometry required for subjects with a history of asthma.  Spirometry results acceptable within 3 months of screening visit; otherwise spirometry must be 
performed and results obtained prior to randomization. Post screening spirometry may be performed at investigator discretion to assess potential changes in 
lung function.
i.
Contraception check is for WOCBP and/or male subjects who are able to father children and are sexually active and whose partners are at risk for pregnancy. 
j.
Site may insert IV catheter for blood sample collection up to 24 hours prior to study drug administration only for subjects who will be admitted to the clinical 
site a day prior to dosing.  IV catheter for blood sampling may be replaced with phlebotomy procedures at the investigator’s discretion. All blood samples 
for laboratory testing must be drawn from the extremity contralateral to that into which test article will be administered. If an indwelling catheter is used, 
heparin is not to be utilized to maintain patency.
k.
After all pre-dose procedures have been completed, insert IV catheter for study drug infusion for IV administration only.
l.
Subjects may undergo a urine drug test or alcohol breath test at the discretion of the investigator at any time during the study.  An alcohol breath test is not 
mandatory but may be given at Screening or any other time during the study at the discretion of the investigator.
m. HBsAb test if screening results for HBsAg are negative and HBcAb are positive.
n.
Serum FSH for all females who are amenorrheic for at least 12 consecutive months.
o.
To be completed for female subjects of childbearing potential. Urine pregnancy tests must be done at home by female subjects of childbearing potential 
every month between the scheduled follow-up visits (these includeWeek 28, Week 32, Week 40 and Week 44) and every month between the scheduled 
extended visit follow-up visits. PI must be informed immediately if pregnancy test is positive and must see the PI for retesting (see Section 7.2.1.2).
p.
Vital signs (Supine BP, PR, temperature), RR and ECG must be performed as close to the dosing time as possible. 
t.
Per SOA or as required; see Section 1.3.1.3.
u.
Subjects will be frequently monitored for infusion site reactions from start of drug administration until the end of infusion.
v.
See Appendix 6: Clinical Criteria for Diagnosing Anaphylaxis Guidance to assist with identifying cases of potential anaphylaxis while monitoring for 
adverse events.  Any signs or symptoms of anaphylaxis should be treated according to the Investigator’s standard of care and reported as an adverse event.
 
y.
Visit windows defined from Day 1 (applies to all activities unless otherwise noted).
z.
Only if before Week 16.
aa. post-dose RR measurements at Investigator’s discretion.
bb. EOS visit if needed. See Section 6.2.7. 
cc. At investigator’s discretion.
dd. Inpatient subjects will be admitted to the clinic day prior to the dosing visits (Day 1, Day 29, Day 57, Day 85).
CCI
C
C
I
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1. INTRODUCTION
1.1. Mechanism of Action/Indication
1.1.1. Mechanism of Action
PF-06817024 is a humanized antibody against interleukin-33 (IL-33).  IL-33 is a member of 
the IL-1 family of cytokines, which has been shown to drive a broad range of Type 2 
inflammatory mediators.1,2  By binding IL-33, PF-06817024 prevents IL-33 from binding to 
its receptor, IL1RL1 (aka ST2, IL-33Ra, IL-1R41,3), and thereby precludes downstream 
signaling.  Type 1 inflammation drives phagocytic activity, is essential for anti-viral, 
anti-bacterial, and anti-fungal host defense, and is characterized by IL-2, IL-12, IL-18, IFNg, 
TNFa, and LTa.4  Type 2 inflammation mediates anti-helminth host defense, but is also the 
immune response central in the development and persistence of atopic and allergic diseases, 
and is characterized by IL-4, IL-5, IL-9, and IL-13.4,5
IL-33 plays an important role in amplifying immune responses via its release from epithelial 
and endothelial cells and through its action on multiple target cells of both the innate and 
adaptive immune subsystems.1,2 The IL-33 receptor is expressed on mast cells, basophils, 
eosinophils, T lymphocytes (Th2), natural killer T-lymphocytes (NKT), natural killer cells 
(NK) and innate lymphoid cells (ILCs, specifically type 2 ILCs, referred to as ILC2s), and 
accordingly drives a predominantly type 2 response.  IL-33 induces cytokines such as IL-5, 
IL-9, IL-13, and granulocyte-macrophage colony stimulating factor (GM-CSF) in many of 
these cells types,2 and induces IL-4 in basophils,6,7 and IL-31 in T-cells.8,9 Many chemokines 
are also induced by IL-33 which, in turn, rapidly recruits myeloid cells, both monocytic and 
granulocytic, to these surface tissues.1,2 The release of IL-33 is triggered by many stimuli 
that often lead to cell death or damage, such as exposure to allergens with proteolytic 
activity, physical damage to the epithelium, viruses that infect the epithelium, as well as 
exposure to bacteria and fungi that are common at the body surfaces.  Central to IL-33’s role 
in atopic diseases is this sequence of events: damage to the epithelium leading to release of 
IL-33; released IL-33 acting on local, IL-33 receptor bearing immune cells; and those cells in 
turn producing cytokines that drive a type 2 inflammatory response.
Given IL-33’s role in driving Type 2 inflammatory response and key disease related
cytokines, IL-33 blockade represents a compelling approach to the treatment of atopic and
allergic diseases including chronic rhinosinusitis with nasal polyps (CRSwNP) and atopic 
dermatitis (AD).
1.1.2. Indication
PF-06817024 is being developed for the treatment of CRSwNP and other allergic diseases
including atopic diseases such as AD, given its potential for broadly inhibiting type-2 
inflammation.

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1.2. Background
1.2.1. Drug Development Rationale
1.2.1.1. Chronic Rhinosinusitis (CRS) 
Chronic rhinosinusitis (CRS) is clinically defined as inflammation of the nose and paranasal 
sinuses, manifest in at least 8-12 weeks of symptoms including nasal obstruction/congestion, 
nasal discharge, facial pain/pressure, and reduction of or loss of sense of smell.10,11  In a 
subset of these patients, inflamed mucosa protrudes into the nasal and sinus passages, and 
this subset is termed chronic rhinosinusitis with nasal polyposis.  Due to the symptoms of 
CRS detailed above, and additional issues including sleep disturbance and headache, patients 
with CRSwNP have a significantly lower quality of life than that enjoyed by healthy 
peers.11,12
Surgery is the mainstay of treatment of CRSwNP, with 46% of CRSwNP patients in the US 
undergoing surgery within 4.7 months of diagnosis.13  While surgery provides significant 
relief from symptoms and improvement in quality of life,12,14 post-surgical recurrence of 
disease is common, with approximately 20% of patients experiencing regrowth of polyps 
within 3 years.11,15  In a 20-year follow-up study of patients who had undergone surgery for 
nasal polyposis, 85% of patients had nasal polyposis on endoscopy at the end of the study, 
indicating nasal polyps recur in the vast majority of patients over time.16  Although intranasal 
corticosteroids are approved by the Food and Drug Administration (FDA) for the treatment 
of nasal polyps, the high rates of surgery, which is reserved for disease refractory to medical 
treatment, suggest that intranasal corticosteroids are inadequately efficacious in the treatment 
of CRSwNP.  Thus at present, there is significant unmet medical need for new therapies to 
treat CRSwNP.
While the exact causes of CRS and CRSwNP are not completely elucidated at present,
significant progress has been made in understanding CRSwNP.17,18  Work over the last
several decades has refined our understanding of the inflammatory response driving
CRSwNP.  In 80% of CRSwNP patients in the United States (US) and Europe, the
inflammatory infiltrate in CRSwNP is dominated type 2 inflammation.18,19 As detailed in
Section 1.1.1, IL-33 drives type 2 inflammation by inducing key disease-related cytokines
(IL-4, IL-5, IL-13, and others).2,6,7,8,9 Taken together, the established importance of type 2 
cytokines in CRSwNP,18,20,21 the role of IL-33 in driving type 2 inflammation,1,2 the genetic
association between variants in the IL-33 and IL1RL1 loci and allergic diseases,22-25 and the
observed release of IL-33 and presence of IL1RL1 positive cells in CRSwNP26 support the
hypothesis that blockade of IL-33 would be beneficial in CRSwNP.
1.2.1.2. Moderate to Severe Atopic Dermatitis
Atopic dermatitis (AD), also known as atopic eczema, is a common, chronic, inflammatory 
skin disorder characterized by flaky skin lesions, intense pruritus, and a general deterioration 
in the quality of life.  The lifetime prevalence of AD in children is 10-20% with 70% of cases 
occurring in children <5 years of age.  Most cases (approximately 75%) improve by 
adulthood, while approximately 25% of AD subjects have symptoms throughout their life.  
The majority of studies conducted across multiple age groups suggest a continued decrease in 

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prevalence with older age.54 Although less common, adult-onset AD occurs.  The prevalence 
of AD in adults is estimated to be 10%.55
The complex pathophysiology of AD is still not completely understood.  However, it has 
been established that the pathophysiology of AD includes a defective skin barrier function, 
allergic responses, defective antimicrobial immune defense, and a genetic predisposition.  
The predominant symptom of AD, pruritus and the resulting scratching typically sets off an 
amplification cycle of atopic skin inflammation.  Activation of T lymphocytes, dendritic 
cells, macrophages, keratinocytes, mast cells, and eosinophils results in a release of 
numerous pro-inflammatory cytokines and chemokines.  This amplification cycle sustains the 
inflammatory responses characteristic of the AD lesions.56 Acute AD lesions have been 
associated with the type 2 helper T cell (TH2) phenotype, showing dominance of IL-4, -5, 
-13, and -31 secretion.56,57,58 Recent evidence supports IL-31’s role in pruritus and 
inflammation in AD.57,58 IL-33 is an important upstream regulator of these pro-inflammatory 
cytokines.
There are a limited number of treatments available for AD.  Current treatments for mild to 
moderate AD include emollients, topical corticosteroids (eg, betamethasone, clobetasol, 
fluocinonide), topical calcineurin inhibitors (eg, pimecrolimus, tacrolimus), and coal tar 
preparations.  Additional treatments generally reserved for severe AD include phototherapy 
(eg, ultraviolet A light [UVA] with or without psoralen, ultraviolet B light [UVB] 
narrowband or broadband) and systemic agents (eg, corticosteroids, cyclosporine, 
recombinant IFN-, mycophenolate mofetil, methotrexate [MTX], azathioprine, intravenous 
immunoglobulin.59  Of the currently available therapies, none offers a cure. Therefore, the 
main aims of existing treatments are to reduce the occurrence of acute flares, to reduce the 
extent and severity of involved eczematous skin, and to reduce pruritus and the resulting 
sleep disturbance.60,61
Currently available therapies for the treatment of AD have multiple limitations. The topical 
therapies have drawbacks related to the duration of use due to the potential for local and 
systemic side effects (eg, corticosteroid use is limited to 2 to 4 weeks) and to the body 
regions of use (eg, mid-high potency corticosteroids are not approved for use on the face 
and/or intertriginous areas).  For AD subjects not responding to topical therapies and 
phototherapy, off-label use of systemic agents, which include both oral corticosteroids and 
oral immunosuppressants, remain the last viable treatment option.  Systemic therapy options 
are associated with potentially severe adverse effects and require careful monitoring.  The 
risk of toxicity and side effects remain a concern when systemic agents are used.  For these 
reasons the use of these agents is limited to short courses or intermittent therapy.  Therefore, 
the predominant unmet medical need in the treatment of AD is an effective therapeutic agent 
without restrictions on long-term or continuous use without significant side effects.
Dupilumab is a recently approved, fully human monoclonal antibody that blocks the activity 
of IL-4 and IL-13 signaling, that has shown efficacy in subjects with moderate - severe AD.53  
Systemic treatment with dupilumab in adults with moderate to severe AD resulted in marked 
reductions in signs and symptoms of AD, and associated levels of type 2 inflammatory 
biomarker, such as thymus- and activation-reguated chemokine (TARC)/chemokine 

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(C-C motif) ligand 17 (CCL17).  Since cytokines such as IL-5, IL-17, IL-22, and IL-31 have 
been implicated in the pathophysiology of AD in addition to IL-4 and IL-13, inhibition of 
IL-33 has the potential to suppress more of the Th2 inflammatory process than therapies 
targeting just IL-4 and IL-13. IL-33 therefore represents an attractive therapeutic target for 
AD and has the potential for superior efficacy compared to dupilumab due to a broader 
inhibition of the underlying inflammation.
Although the breadth of IL-33 mediated Type 2 inflammation provides the rationale for drug
development in CRSwNP and other atopic/allergic diseases such as AD, it should be noted
that IL-33 does not play an essential role in clearing viral and bacterial infections1,2
suggesting a favorable safety profile. In addition, as with any antagonist of Type 2
inflammation (ie, anti-IL-5, anti-IL-13, anti-IL-4/13), there is a potential risk of increased
susceptibility to parasitic infections, specifically to helminths, with IL-33 blockade.5
1.2.2. Nonclinical Pharmacology
PF-06817024 is a humanized monoclonal antibody that binds to human IL-33 and blocks the 
interaction of IL-33 with suppression of tumorigenicity 2 (ST2).  PF-06817024 binds IL-33 
with high affinity, measured by surface plasmon resonance to be 70 picomolar (pM) on 
reduced wild-type (wt) IL-33 and 13 pM on IL-33 (mm2), a form of IL-33 that is maintained 
in an active state by mutation of its four cysteine residues to serine.27  PF-01687024 does not
bind with any significant affinity to the oxidized (inactive) forms of IL-33(wt) or to other 
IL-1 family cytokines tested (IL-1, IL-1, IL-18, IL-36, IL-36).  PF-06817024 binds to 
cynomolgus monkey IL-33(mm2) with an affinity of 10 pM.
PF-06817024 blocks the binding of purified IL-33 receptor (ST2) to IL-33 and
correspondingly inhibits the activity of IL-33 in multiple cell-based assay formats.  
PF-06817024 inhibits the activity of IL-33 on human mast cells with an half maximal 
inhibitory concentration (IC50) of 64 pM and demonstrates neutralizing activity in other cell 
based formats, including human whole blood, peripheral blood mononuclear cells, and 
recombinant cell lines overexpressing the receptor with IC50s ranging from 1 pM to 1000 pM. 
PF-06817024 is also shown to bind to native IL-33 using human cell lysates and in in vivo 
toxicity studies with cynomolgus monkeys. 
PF-06817024 is a humanized Immunoglobulin Gamma 1 (IgG1)/kappa molecule. The 
variable-domain sequences of PF-06817024 outside the complementarity-determining 
regions (CDRs) are identical to those of the human germlines VH3 DP-54 and VK1 DPK9, 
and overall the molecule is 95% human. PF-06817024 has been further engineered to have 
an extended half-life and minimal interaction with Fcreceptors and complement while 
retaining full IL-33 neutralization activity.

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1.2.3. Nonclinical Pharmacokinetics
After a single intravenous (IV) dose of PF-06817024 to cynomolgus monkeys, the mean 
clearance (CL), volume of distribution at steady state (Vss), and terminal half-life (t½) values 
were 0.058 mL/h/kg, 56 mL/kg, and approximately 18 days, respectively. Additionally, 
single dose toxicokinetics (TK) were evaluated after IV or subcutaneous (SC) dosing in an 
exploratory toxicity study. Systemic exposure increased with increasing dose in the IV dose 
groups and sex-related differences in exposure were not observed. SC bioavailability was 
approximately 78%.  No anti-drug antibodies (ADA) were detected following a single 
IV dose to cynomolgus monkeys.
After repeat IV or SC administration of PF-06817024 to cynomolgus monkeys in 13- and 
27-week toxicity studies, systemic exposure (as assessed by the highest drug concentration 
observed in serum [Cmax] and area under the serum drug concentration-time curve from 0 to 
504 hours [AUC504]) increased with increasing dose in the IV dose groups. Accumulation 
was observed with mean Area under the Curve (AUC) ratios ranging from 1.4 to 3.2 between 
Day 1 and Day 64 or 169. There were no apparent sex-related differences in systemic 
exposure observed. The incidence of antidrug antibody (ADA) induction to PF-06817024 
was 42% across all-repeat dose groups in the 13-week study and 33% in the 27 week study.  
Exposures (as assessed by maximum observed concentration (Cmax) and AUC504) were 
generally similar in ADA-positive animals compared to ADA-negative animals. 
Based on the pharmacokinetics (PK) observed in cynomolgus monkeys, the PK of
PF-06817024 in humans is predicted based on allometric scaling and the PK of PF-06817024 
in humans is assumed to be linear.  The projected PK parameters include absorption rate 
constant of 0.18 day-1, SC bioavailability of 78%, plasma CL of 0.082 L/day, 
inter-compartmental CL of 0.39 L/day, Vss of 2.1 L (central) and 2.4 L (peripheral), and a 
t½ of 41 days.
1.2.4. Nonclinical Safety Data
The toxicity of intravenously or subcutaneously administered PF-06817024 has been
evaluated in a single dose exploratory study, and pivotal 13-week and 27-week (chronic)
repeat-dose studies in sexually mature and sexually immature cynomolgus monkeys
respectively. The IV and SC routes of administration were selected for these studies since 
they are the intended routes of clinical administration. Separate safety pharmacology studies 
were not conducted with PF-06817024, but safety pharmacology endpoints 
(electrocardiogram measurements) evaluating the potential effects of PF-06817024 on the 
cardiovascular (CV) system were included in the 13- and 27-week repeat-dose toxicity 
studies in cynomolgus monkeys.  Administration of PF-06817024 to cynomolgus monkeys 
once every 3 weeks for 13 weeks or 27 weeks at doses of 20 (IV), 200 (IV), 300 (IV), 
80 (SC), or 90 (SC) mg/kg did not produce any effects on safety pharmacology endpoints,
including waveform morphology, heart rate, or RR-, PR-, QRS-, QT-, or QTc- intervals. No 
target organ toxicity or adverse effects were identified in cynomolgus monkeys in either 
study via IV or SC administration.  In the 13-week toxicity study in sexually mature 
monkeys, no effects were seen in reproductive tissues.

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Additional studies conducted to support nonclinical development, including a human 
cytokine release assay and a tissue cross-reactivity study, did not identify specific human 
risks.  Although ADA induction was observed across all IV and SC PF-06817024-dosed 
groups following repeat-dose administration serum exposures (as assessed by Cmax and 
AUC504) were generally similar in ADA-positive animals compared to ADA-negative 
animals, indicating ADA induction did not affect exposure. No ADA induction was detected 
following a single IV dose to monkeys.
Given the lack of target organ toxicity or adverse effects observed in either study, the 
no-observed-adverse-effect-levels (NOAELs) in the 13-week study were the highest doses 
tested, 300 mg/kg/dose (IV) and 90 mg/kg/dose (SC). The NOAELs in the 27-week study 
were the highest doses tested, 300 mg/kg/dose (IV) and 80 mg/kg/dose (SC).  As the no 
observed adverse effect levels (NOAELs) are the maximum doses evaluated in the 13 and 
27 week good laboratory practice (GLP) toxicity studies in monkeys, the PK exposure limit 
in humans will be established based on the exposures achieved in the 13 week GLP toxicity 
study, as this study produced lower steady state exposures than the 27 week study.  Thus, the 
human exposure limits will be set to be Cav of 442.0 g/mL (calculated as AUC504 of 
2230000 g•h/mL divided by 504 hours), which is 1/10th of the mean Cav at the IV NOAEL 
dose in the 13 week GLP toxicity study in monkeys. In the 13-week study, at 
300 mg/kg/dose IV, Cmax and Cav safety margins relative to the highest planned clinical 
IV dose of 600 mg (every 4 weeks) are 27x and 12x, respectively.
Collectively, the nonclinical program supports the chronic use of PF-06817024 in clinical 
trials in both males and females (including women of childbearing potential with use of 
appropriate contraception, see Section 4.3.1.5).
Additional information for this compound may be found in the single reference safety
document (SRSD), which for this study is the Investigator’s Brochure (IB).
1.2.5. Emerging, Preliminary, Draft Data from Healthy Subjects in Parts 1, 2 and/or 3
1.2.5.1. Safety Data
The clinical experience with PF-06817024 to date has consisted only of data emerging from 
the current study. As of 01 February, 2018 (the date of the last database cut-off), a total of 
71 subjects have received blinded therapy (PF-06817024 or placebo) by IV or SC 
administration in the current, of which 49 are healthy subjects, 20 are subjects with CRSwNP
and 2 are subjects with moderate-severe AD. Escalating doses of PF-06817024 tested in 
healthy subjects have included single doses of 10 mg, 30 mg, 100 mg, 300 mg and 1000 mg, 
a repeat dose of 100 mg all administered IV, and a single dose of 30 mg administered SC. 
Subjects with CRSwNP have been administered a single IV dose of 300 mg of PF-06817024 
or placebo. Subjects with moderate-severe AD recruited as of the cut-off date have been 
administered the first IV dose of 600 mg of PF-06817024 or placebo. Subjects in the healthy 
and CRSwNP cohorts (Parts 1 and 2) have been followed for up to approximately 1-2 years.

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As this study is currently ongoing and blinded, only summary, preliminary, blinded, 
unaudited safety, tolerability, PK, and immunogenicity data are available and presented 
below. Given the limited number of AD subjects recruited, the cumulative safety data to date 
primarily reflect the safety and tolerability in healthy subjects and subjects with CRSwNP 
(Parts 1 and 2). As of the above cutoff data, adverse effects (AEs) have been observed in 
57 of 71 subjects (80.3%) receiving blinded therapy. The most commonly reported 
treatment-emergent adverse events (TEAEs) have fallen under the Medical Dictionary for 
Regulatory Activities (MedDRA) System Organ Classes (SOC) of Infections and Infestations
(36.6%), Gastrointestinal Disorders (19.7%), Injury, Poisoning and Procedural 
Complications (16.9%), Musculoskeletal and Connective Tissue Disorders (15.5%), and 
Nervous System Disorders (15.5%). The most common (occurring in 3 or more subjects) 
AEs by Preferred Term were: upper respiratory tract infection (10 subjects, 14.1%); sinusitis, 
pain in extremity, nasal congestion, ecchymosis (5 subjects, 7.0%, each); and oral herpes, 
nausea, back pain, and dizziness (3 subjects, 4.2%, each). The safety profile has been 
generally similar across the healthy and CRSwNP subjects. Adverse effects in the System 
Organ Class of Respiratory, Thoracic, and Mediastinal Disorders appeared to be more 
frequent in the subjects with CRSwNP than in healthy subjects, likely reflective of their 
underlying disease. A variety of mild transfusion-related reactions were noted in the early 
cohorts of Part 1 of Study C0341001 in healthy subjects, but these were mitigated when the 
infusion time was increased from 60 to 90 minutes. In general, ongoing review of the 
preliminary data has revealed the AEs to be generally mild-moderate in severity and 
self-limited. 
As of the date of the last database cut-off, there have been no deaths, or suspected 
unexpected serious adverse reactions (SUSARs) associated with the administration of 
blinded treatment. There have been 3 serious adverse effects (SAEs). One SAE was due to a 
motor vehicle accident in a healthy subject who had received a single dose of PF-06817024, 
1000 mg IV, or placebo. The other two SAEs were due to 2 separate events (approximately 
9 months apart) of respiratory tract infection in a single subject with CRSwNP and comorbid 
asthma who received a single dose of 300 mg PF-06817024 or placebo IV. Since all of the 
SAEs were in subjects participating in single dose cohorts, there were no discontinuations 
due to the SAEs; both subjects with SAEs have remained in the study for follow-up (between 
1-2 years). One subject was lost to follow-up as subject did not want to return for extended 
follow up visits after completion of Day 211 visit. Additional details may be found in the 
current version of the Investigator’s Brochure, the SRSD for PF-06817024.
1.2.5.2. PK Data
Based on a preliminary, draft dataset obtained in January 2018 and including interim data 
from subjects in the first two parts of the study, a non-compartmental PK analysis was 
performed and the derived PF-06817024 PK parameters are summarized descriptively in 
Table 1. 

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Following single IV doses in healthy subjects, the median time for occurrence of maximal 
concentration (Tmax) ranged between 1.76 and 3 hours, while the median Tmax after SC 
administration (30 mg) was 338 hours (≈14 days). PF-06817024 had a prolonged half-life 
(t1/2) with mean values ranging from 79 to 94 days across all single dose healthy volunteer 
cohorts. Both maximal plasma concentration (Cmax) and area under the concentration-time 
curve from time 0 to infinity (AUCinf) appeared to be approximately dose proportional in 
healthy subjects across the 10-1000 mg IV range (see Table 1), indicating that PF-06817024 
exhibits linear kinetics in humans within this dose range. Clearance (CL) values (geometric 
mean) ranged from 0.00206 L/h to 0.00259 L/h across all single IV dose healthy volunteer 
cohorts. Using the calculated geometric means of AUCinf after single IV infusion and 
SC administration of the same dose (30 mg) in healthy subjects (8579/14590, see Table 1), 
the bioavailability (F) after SC administration is approximately 59% relative to IV infusion.
Multiple dose PK data were available only for 4 healthy subjects from the 100 mg IV cohort 
who received an additional 100 mg IV dose. The (geometric) mean Cmax after the second 
dose was 42.47 g/mL (geometric CV of 11%) across these 4 subjects and the associated 
median Tmax was 1.54 hours. The (geometric) mean area under the concentration-time curve
from the time of the second dose until 720 hours post-dose (AUC) and until infinity 
(AUCinf) was 16540 (geometric CV of 13%) and 73400 g•hr/mL (geometric CV of 23%) 
respectively. Finally, the mean calculated t1/2 after the second dose was 108 days (standard 
deviation (SD) of 10).
Following 300 mg IV administration in CRSwNP patients the median Tmax was 2 hours and 
the associated (geometric) mean Cmax was 89.79 g/ml. These values are very similar to 
those observed in healthy subjects at the same dose (Tmax at 2 hours and Cmax of 
97.49 g/mL). Since the available data from the ongoing CRSwNP cohort were relatively 
limited, some PK parameters (eg, t1/2, AUCinf) were not calculated for the majority of the 
subjects. However, from currently available data, PF-06817024 concentration-time profiles 
in CRSwNP patients are not expected to be different compared to healthy subjects.

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Table 1.
Summary of Serum PF-06817024 Pharmacokinetic Parameter Values 
Following Intravenous (IV) Infusion and Subcutaneous (SC) 
Administration, Study C0341001 (Preliminary Data)
10 mg IV 
SD
(HV)
30 mg IV 
SD
(HV)
100 mg IV 
SD
(HV)
300 mg IV 
SD
(HV)
1000 mg IV 
SD
(HV)
30 mg SC 
SD
(HV)
300 mg IV 
SD 
(CRSwNP)
N, n1,  n2
6, 6, 5
6, 6, 6
7, 7, 3a
6, 6, 6
6, 6, 5
6, 6, 6
11, 11, 1b
AUCinf
(μg·hr/mL)
4377 (28)
14590 (28)
44510 (22)
116000 (22)
421000 (11)
8579 (37)
122000
AUCinf (dn) 
(μg·hr/mL/mg)
437.7 (28)
486.8 (28)
445.1 (22)
386.6 (22)
421 (11)
285.5 (37)
407
Cmax (μg/mL)
2.395 (51)
12.26 (20)
35.44 (12)
97.49 (7.5)
313.2 (17)
2.471 (43)
89.79 (41)
Cmax (dn) 
(μg/mL/mg)
0.2395 (51)
0.4091(20)
0.3544 (12)
0.3249 (7.5)
0.3132 (17)
0.0823 (43)
0.2994 (41)
Tmax (hr)
3.00
(1.15-4.05)
1.76
(1.02-2.33)
2.00
(1.03-8.03)
2.00
(1.53-8.00)
1.78
(1.53-4.00)
338
(338-1080)
2.00
(1.00-170)
CL, CL/F 
(L/hr)
0.002283 
(28)
0.002055 
(28)
0.00225 (22)
0.002587 
(22)
0.002375 
(11)
0.003498 
(37)
0.00246
t1/2 (Days)
89.9 ±16.14
87.85 ±16.95
81.77 ±33.74
78.73 ±16.75
89.14 ±8.524
93.58 ±13.82
105
Geometric mean (geometric %CV) for all except: median (range) for Tmax; arithmetic mean ± standard deviation for t½.
N = number of subjects in the treatment group; n1 = number of subjects contributing to the summary statistics; n2 = number of subjects 
with reportable t½, AUCinf, AUCinf (dn) and CL (or CL/F); SD = single dose; HV = healthy volunteers; CRSwNP = chronic 
rhinosinusitis with nasal polyps patients; IV = intravenous; SC = subcutaneous; CL = Dose/AUCinf for SD IV treatments; 
CL/F = Dose/AUCinf for SD SC treatments.
a n2  = 3 for subjects remained in the SD period.
b Individual subject values reported.
Preliminary data from this ongoing Phase 1 study show that the incidence of anti-drug 
antibodies (ADAs) in PF-06817024 treated subjects is low (approximately 10%), with no 
apparent dose dependency. Data from neutralizing antibody (NAb) assays are not currently 
available.
1.3. Rationale
1.3.1. Study Rationale
1.3.1.1. Parts 1 and 2
This is a first-in-human, placebo-controlled, double blind (pharmacist and sponsor open),
single and multiple IV and SC dose study that will be conducted in two parts.  Part 1 is a
first-in-human, placebo-controlled, double blind, dose escalation study conducted in healthy 
subjects who may be mildly atopic.  In Part 2, single doses of PF-06817024 will be given to
one or more cohorts of patients with CRSwNP to enable initial evaluation of safety and
tolerability in this patient population.
In all cohorts, the duration of the follow-up is selected to be 7 months after the last dose, 
which is ≥5 times the projected half-life of 41 days. If the emerging data project that half-life 
is longer than 41 days, the subjects will be asked to return for extended follow-up visit(s) at 
up to 3 month intervals beyond the last follow-up visit to cover approximately ≥5 times the 
observed half-life
 
 OR of sufficient 
duration to have projected exposures decrease below ADA drug tolerance levels 
 
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Part 1
Part 1 is a first-in-human, placebo-controlled, double blind (pharmacist and sponsor open),
dose escalation study in healthy subjects who may be mildly atopic (see Section 3.1 for 
detailed study overview and Figure 1 for a schematic of the study design). As the current
study is the first to dose PF-06817024 to humans, an escalating dose design is proposed with
careful assessment and ongoing review of safety and analysis of pharmacokinetics of
PF-06817024. The population selected for Part 1 of the study is healthy subjects who may be
mildly atopic. For Part 1 Cohorts 1-4, subjects are required to be Phadiatop positive and 
have an IgE ≥50 kU/L (see Section 4.1 for inclusion/exclusion criteria). ImmunoCAP 
Phadiatop is a blood test designed to differentiate between atopic and non-atopic subjects.  
This test demonstrates the presence of specific IgE antibodies to common inhalant allergens.  
Total IgE levels ≥50 kU/L was selected as a threshold to provide adequate levels of IgE to 
reliably detect a treatment-related decrease in this pharmacodynamic (PD) biomarker. 
 
 
 
The study design consists of single ascending doses (SAD) with selected cohorts rolling into 
a multiple dose component to receive a second dose at a minimum of 4 weeks (maximum of 
12 weeks) after the first dose (see Section 3.1). The design is chosen to optimize the
efficiency of the study, relative to the traditional design of a separate sequential multiple 
ascending dose study, without compromising subjects’ safety.  In general, single dose
escalation will be conducted with IV administration. Subjects from the selected cohorts will
receive a single IV dose of PF-06817024.  After safety and PK at this dose and the next
higher dose level have been confirmed, and sufficient exposure coverage for the second dose
has been predicted, the same subjects will receive a second dose at the same dose level as the
first dose (at a minimum of 4 weeks after the first dose) to evaluate the safety and PK of
multiple doses of PF-06817024.  A single cohort will receive one or more SC dose levels (at 
a minimum of four weeks apart) to allow evaluation of the safety and PK with SC
administration.  This cohort will similarly not be given a second dose until PK and safety of
the first SC dose have been established, and sufficient exposure coverage for the second dose
at a different dose level (based on safety and PK from an IV cohort) have been predicted.  
Please refer to Section 3.3 for details of dose escalation rules and criteria for administration 
of the second dose for multiple dose cohorts.
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Part 2
Part 2 is a placebo-controlled, double blind (pharmacist and sponsor open) evaluation of 
single IV doses in one or more cohorts of patients with CRSwNP to assess the safety, 
tolerability, PK,
 of PF-06817024 in this 
population. Part 2 dosing will start after the safety, tolerability and PK at the same or higher 
dose has been established in Part 1. Two cohorts of subjects with CRSwNP are planned. 
A decision on the number (1 or 2) of cohorts will be made in light of emerging safety, 
tolerability, PK, 
 of PF-06817024. Subjects in each cohort will be randomized in 
either a 1: 1 or 2: 1 (PF-06817024 : placebo) ratio, depending on the number of cohorts and 
the emerging data. Up to approximately 10 active (per dose) and approximately 15 placebo 
(overall) subjects will be enrolled in Part 2 for a planned total of up to approximately 
35 subjects.
 
 
 As the same or
higher dose of PF-06817024 will have already been administrated to subjects in Part 1, and
safety, tolerability, and PK thereby established prior to the start of Part 2, the reduction in the 
duration of clinical confinement and the reduction in the number of follow-up visits (but not 
the duration of follow-up) for this cohort is justified.  
 
 
 
 
 
 
Overall, inclusion of patient cohorts in
the first in human (FIH) study will provide key data in a timely manner to inform future
clinical development.
1.3.1.2. Part 3
Part 3 is a placebo-controlled, double blind, pharmacist and sponsor open, cohort to evaluate 
safety, tolerability, PK, immunogenicity, 
of repeat doses of 
PF-06817024 administered to subjects with moderate to severe AD. Approximately 
20 subjects are planned to be enrolled in this cohort. Subjects will be randomized to receive 
PF-06817024 or placebo in a 3: 1 ratio (PF-06817024: placebo).  Additional subjects up to a 
total of approximately 32 may be enrolled in a 3: 1 ratio (PF-06817024: placebo)
 
 
. Subjects randomized to PF-06817024 will 
receive a loading dose of 600 mg IV on Day 1, followed by 3 doses of 300 mg IV every 
4 weeks (last dose being on Week 12). Placebo subjects will receive 4 IV doses of matching 
placebo every 4 weeks. This dosing regimen is expected to decrease the time to steady state 
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exposure and provide nearly complete target coverage 
based on currently 
available in vitro and clinical data. 
 
 
 
 
 
 
 
 
 
 
 
1.3.1.3. Parts 1, 2, and 3
The duration of the follow-up is selected to be at least 1 year after the last dose of study drug 
(at Week 12 for Part 3), which is ≥3 times the preliminary estimated half-life of 
approximately 90 days and >80% exposure (AUC) based on emerging data for the earlier 
cohorts of healthy subjects, which is adequate to estimate the elimination half-life. If the 
emerging data project that pharmacologically relevant exposure will extend significantly 
longer than 1 year, the subjects will be asked to return for extended follow-up visit(s) at up to 
3 month intervals beyond the last planned regular visit until one of the following criteria has 
been met:
•
The follow up period from the last dose of study drug is approximately ≥5 times the 
observed half-life; OR
 
•
The period since the last dose of study drug is of sufficient duration to have projected 
exposures decrease below ADA drug tolerance levels; OR 
 
The Sponsor will inform the sites when subjects may be discharged from the study based on 
review of emerging data indicating that one or more of the above criteria are met. Current 
guidance is that subjects will be in the study for 5 half-lives ie, about 450 days from the last 
dose.
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1.3.2. Dose Rationale
1.3.2.1. Part 1
The approach for dose selection for the 1st part of this study was based on all relevant
information obtained in non-clinical pharmacology and toxicity studies and in absence of any 
clinical data. Considering that chronic exposure is more relevant for the mechanism of
action of PF-06817024, and the dosing interval for the multiple dose component of this study
(a minimum of 4 weeks and maximum of 12 weeks apart) will be different from that in the
Good Laboratory Practices (GLP) monkey toxicity study (every 3 weeks), average 
concentration over dosing interval (Cav) is chosen to be the PK exposure limit. In addition, 
since the no observed adverse effect level (NOAEL) is the maximum dose evaluated in the
13 weeks GLP toxicity study in monkeys, the PK exposure limit will be set to be Cav of
442.5 g/mL (calculated as AUC504 divided by 504 hours), which is 1/10th of the mean Cav at
the NOAEL dose.
Linear PK is assumed in human PK projection.  Projected Cmax, AUCinf, Cav and the safety
margin relative to the PK stopping limit are listed in Table 2 for the planned dose levels,
including single and multiple dose administration.
Table 2.
Predicted Human Exposure and Safety Margins Relative to Exposure Limits 
at Planned Dose Levels for Part 1
Regimen and 
Route of 
administration
Proposed 
Human Dosea
(mg)
Predicted Human PK
Safety Margine
Cmax
(g/mL)
AUCc
(g•hr/mL)
Cav
d
(g/mL)
Cav
SD IV
10
4.7
2925
1.8
247.2
SD IV
30
14.2
8774
5.4
82.7
SD IV
100
47.2
29247
17.9
24.8
SD IV
300
141.5
87741
53.5
8.3
SD IV
1000
471.7
292470
178.4
2.5
SD IV
2000
943.4
584940
356.7
1.2
MDb IV
100
58.9
19445
27.0
16.4
MDb IV
300
176.7
58316
81.0
5.5
MDb IV
1000
588.9
194430
270.0
1.6
1st dose SCf
100
14.5
22813
12.0
36.9
2nd dose SCf
300d
52.3
31604
43.9
10.1
IV = Intravenous; MD = multiple dose; ND = not determined; SD = single dose.
a.
Depending on the safety and PK data available, dose escalation may be adjusted to doses other than those
outlined and will follow dose escalation and stopping rules (Section 3.2).
b.
Total of 2 doses are given 30 days apart in human PK simulation (=720 hr), PK parameters are derived 
from concentration time profile after the second dose.
c.
AUCinf for single or 1st dose and AUC0-720 for the 2nd dose.
d.
Human Cav is calculated as AUC 0-720/720.
e.
Based on PK stopping limit of Cav= 442.5 g/mL.
f.
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  With single IV dosing, the
10 mg proposed starting dose is estimated to provide an exposure margin of 247.2-fold for
Cav. Analysis using the human equivalent dose (HED) approach indicates that the margin for
proposed starting dose of 10 mg is 726-fold for a 75 kg individual relative to NOAEL of 
300 mg/kg/dose (IV) in cynomolgus monkeys.  The highest proposed IV infusion dose of
2000 mg is estimated to provide an exposure margin of 1.2-fold for Cav.
The multiple dose range planned is 100 mg to 1000 mg IV at a minimum of 4 weeks apart for
a total of 2 doses. The starting dose of 100 mg IV for the multiple dose period is predicted to
have a safety margin for Cav of 16.4-fold (Table 2). At the highest proposed dose of 1000 mg
IV the safety margin for Cav is 1.6-fold.
Intermediate or lower doses may be evaluated instead of or in addition to the planned dose
level(s). Dose escalation may be stopped at any time. Cohorts and/or additional subjects
may be added if unplanned intermediate doses are to be evaluated for safety, PK, or
reasons. For any dose administered, the predicted exposure will not exceed the PK stopping
limit.
1.3.2.2. Part 2
Single IV doses of PF-06817024 in one or two cohorts of patients with CRSwNP will be
studied in Part 2. The need for a second dose and the doses selected for each cohort will be
based on the emerging data from the study and will not exceed the highest dose tested in
Part 1 that is found to be safe and well-tolerated.
1.3.2.3. Part 3
The dose rationale for Part 3 was based on emerging preliminary clinical data from the other 
parts of this study. The proposed dosing regimen of PF-06817024 for Part 3 consists of a 
single 600 mg IV loading dose followed by 3 doses of 300 mg IV every 4 weeks. 
As discussed in Section 1.2.5.2 and presented in Table 1, the emerging clinical data from 
cohorts in Part 1 show that the half-life of PF-06817024 is approximately 79-94 days.
Preliminary modeling using interim PK 
 data available at the time of Protocol 
Amendment 4 from the healthy subject cohorts suggested that monthly dosing of 
PF-06817024 may be required for continuous, high level, suppression of IL-33 levels, despite 
the long half-life of PF-06817024. In order to shorten the onset of suppression of IL-33 
levels 
, a 600 mg loading dose of PF-06817024 is proposed in 
this study. The proposed dose of PF-06817024, the number doses, and/or the dosing interval 
may be modified in light of emerging safety, tolerability, PK,
 data in this population.
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Assuming that PF-06817024 PK is similar between healthy subjects and AD patients, the 
average concentration (Cav) during the first and the last dosing interval of the proposed 
dosing regimen was predicted to be 84.1 g/mL and 132.5 g/mL respectively. Thus, the 
proposed dosing paradigm will provide safety margins of approximately 5.3-fold and 
3.3-fold relative to the 600 mg loading dose and the third dose of 300 mg (due to 
accumulation the margin for 300 mg is less than the 600 mg), respectively, with respect to 
the toxicokinetic stopping limit of Cav=442.5 g/mL.
2. STUDY OBJECTIVES AND ENDPOINTS
2.1. Objectives
2.1.1. Primary Objectives
Part 1

For the SAD component, the objective is to determine the safety and tolerability of
single IV infusions and single SC doses of PF-06817024 in healthy subjects who may 
be mildly atopic.

For the multiple dose component, the objective is to determine the safety and
tolerability following administration of multiple IV and, potentially, repeat SC doses
of PF-06817024 in healthy subjects who may be mildly atopic.
Part 2

To determine the safety and tolerability of single IV infusions of PF-06817024 in
patients with chronic rhinosinusitis with nasal polyps.
Part 3

To determine the safety and tolerability of repeat IV doses of PF-06817024 in 
subjects with moderate to severe AD. 
2.1.2. Secondary Objectives
Part 1

To characterize the PK profile of PF-06817024 following single IV infusions and 
single SC doses of PF-06817024 in healthy subjects who may be mildly atopic.

To characterize the PK profile of PF-06817024 following multiple IV and, 
potentially, SC doses of PF-06817024 in healthy subjects who may be mildly atopic.

To evaluate immunogenicity of PF-06817024 in healthy subjects who may be mildly
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Part 2
•
To characterize the PK profile of PF-06817024 following single IV infusions of 
PF-06817024 in patients with chronic rhinosinusitis with nasal polyps.
•
To evaluate immunogenicity of PF-06817024 in patients with chronic rhinosinusitis 
with nasal polyps.
Part 3
•
To characterize the PK profile of PF-06817024 following repeat IV doses in subjects 
with moderate to severe AD.
•
To evaluate immunogenicity of PF-06817024 in subjects with moderate to severe 
AD.
 
 
 
 
2.2. Endpoints
2.2.1. Primary Endpoints
Parts 1 and 2
•
Incidence, severity and causal relationship of treatment emergent adverse events
(TEAEs) and withdrawals due to TEAEs through the end of the study.
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
Incidence and causal relationship of treatment emergent serious adverse events 
(SAEs) through the end of the study. 

Incidence and magnitude of abnormal chemistry, hematology, and urinalysis
laboratory findings through the end of the study.

Abnormal and clinically relevant changes in vital sign parameters through the end of 
the study.

Abnormal and clinically relevant changes in electrocardiogram (ECG) parameters
through the end of the study.
Part 3

Incidence, severity and causal relationship of treatment emergent adverse events
(TEAEs) and withdrawals due to TEAEs through the end of the study.

Incidence and causal relationship of treatment emergent serious adverse events 
(SAEs) through the end of the study. 

Incidence and magnitude of abnormal chemistry, hematology, and urinalysis 
laboratory findings through the end of the study.

Abnormal and clinically relevant changes in vital sign parameters through the end of 
the study. 

Abnormal and clinically relevant changes in electrocardiogram (ECG) parameters 
through the end of the study.
2.2.2. Secondary Endpoints
Parts 1 and 2

PK parameters derived from serum PF-06817024 concentrations after single dose or
multiple doses of PF-06817024, through the end of the study as data permits:

Cohorts receiving single dose (IV infusions and SC doses): Cmax, dose normalized 
Cmax(Cmax(dn)), time to reach maximum concentration (Tmax), area under the 
concentration-time profile from time zero to infinity (AUCinf), area under the 
concentration-time profile from time zero to the time of the last quantifiable 
concentration (AUClast), area under the concentration-time curve within dosing 
interval (AUCtau), AUCtau(dn), Cav , t½, mean residence time (MRT), apparent volume 
of distribution (Vz/F) (SC only), apparent clearance (CL/F) (SC only),Vss (IV only),
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•
Cohorts receiving multiple doses (Part 1 only):
•
First Dose: Cmax, Tmax, AUCtau, Cav, Cmax(dn) and AUCtau(dn).
•
Last (ie, second) Dose: Cmax, Cmax(dn), Tmax, AUCtau, AUCtau(dn), Cav, t½, MRT,
Vz/F (SC only), Vss (IV only), CL/F (SC only), CL (IV only), Cmin, observed
accumulation ratio for Cmax (Rac(Cmax )), and Rac(AUCtau).
•
Incidence of ADA immune response through the end of the study.
Part 3
•
PF-06817024 plasma concentrations in subjects with moderate to severe AD.
•
Incidence of development of anti-drug antibodies (ADAs) and neutralizing antibodies 
(NAbs) in subjects with moderate to severe AD.
 
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3. STUDY DESIGN
3.1. Study Overview
The study was originally designed to be a two-part Phase 1, randomized, double-blind
(sponsor and pharmacist unblinded), placebo-controlled, dose escalating clinical study with 
single and multiple doses of PF-06817024 in healthy subjects who may be mildly atopic
(Part 1: Cohorts 1-7) and of one or two single doses of PF-06817024 in patients with chronic
rhinosinusitis with nasal polyps (Part 2: Cohorts 8 and 9).
Amendment 4 adds Part 3, consisting of a single cohort (Cohort 13) of subjects with 
moderate – severe AD.  Cohort 13 is a randomized, double-blind (sponsor and pharmacist 
unblinded), placebo-controlled, multiple dose evaluation of PF-06817024, as indicated in 
Figure 2.
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Figure 1.
Study Design Schematic
Figure 2.
Study Design Schematic for Part 3
Cohorts 3-5 and Cohort 7: second dose occurs at a minimum of 4 weeks and maximum of 12 weeks after the 
first dose.  Second dose is only administered if protocol safety criteria are met (see Section 3.3). 
Except for the starting dose, the actual doses for other cohorts may be changed but will follow dose escalation 
and stopping rules (Section 3.2).
3.1.1. Part 1:
Approximately 56 healthy subjects who may be mildly atopic will be enrolled into the
proposed cohorts listed below.  This study starts with a single ascending dose (SAD) 
escalation design, with selected cohorts rolling into a multiple dose component.  Up to 
approximately 80 healthy subjects who may be mildly atopic will be enrolled if separate 
multiple dose cohort(s) are required.  Subjects may only participate in 1 cohort.
The study will be conducted at one or more clinical research centers.  The above schematic
(Figure 1) demonstrates the study design with the select SAD cohorts rolling over into the 
multiple dose component.  Depending on the safety, 
 and pharmacokinetic 
data available, dose escalation may be adjusted to doses other than those planned in the 
study. Intermediate doses can be evaluated instead of or in addition to the planned dose 
levels. 
A possible dosing scenario is included in the schematic. 
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Subjects will be sequentially randomized into IV cohorts (Cohorts 1 through 6) with Cohort 7
dosing occurring based on the criteria described in Section 3.2 (see Figure 1) as follows:

Cohort 1 (n=8): 10 mg active (n=6) or placebo (n=2), IV.

Cohort 2 (n=8): 30 mg active (n=6) or placebo (n=2), IV.

Cohort 3 (n=8): 100 mg active (n=6) or placebo (n=2), IV x 2 doses.

Cohort 4 (n=8): 300 mg active (n=6) or placebo (n=2), IV x 2 doses.

Cohort 5 (n=8): 1000 mg active (n=6) or placebo (n=2), IV x 2 doses.

Cohort 6 (n=8): 2000 mg active (n=6) or placebo (n=2), IV.

Cohort 7 (n=8): 100 mg (first dose) followed by 300 mg (second dose) active (n=6) or
placebo (n=2), SC.
Within 28 days of successful completion of the screening process, eligible subjects for the
SAD period of the study will be enrolled and randomized to receive a single IV infusion of
PF-06817024 or placebo.  In order to mitigate any unanticipated acute safety risks within the
SAD portion of the study (Cohorts 1 through 6), the first two subjects will be dosed (one
receiving PF-06817024 and one receiving placebo). After a safety pause of at least 24 hours 
in duration, the remaining subjects within the cohort may be dosed.  Cohorts 1 through 6 will
be enrolled sequentially in a dose escalating fashion starting from the lowest dose proposed 
(10 mg).  Subjects will be admitted into the clinic approximately 1 day prior to dosing and
are required to remain in the clinic through completion of Day 5 evaluations.  Subjects in the
single dose cohorts will return for outpatient follow-up visits per Schedule of Activity
Table B (SoA Table B).
The multiple dosing component of the study will consist of those subjects who received a 
single dose of PF-06817024 or placebo in Cohorts 3, 4, 5 and 7. Following the review of 
sufficient safety and PK data from a higher SAD dose, these subjects will be rolled over to 
receive a second dose of PF-06817024 or placebo at a minimum of 4 weeks and a maximum 
of 12 weeks after the first dose is received. If Cohorts 3, 4, or 5 are not able to be rolled over 
to receive a second dose between 4 and 12 weeks, separate IV multiple dose cohort(s) may
be implemented (Cohorts 10 through 12, see below). Cohort 7 is planned to receive a SC
administration of a lower dose of PF-06817024 followed by a second SC administration of a 
higher dose of PF-06817024 at a minimum of 4 weeks and maximum of 12 weeks after the 
first dose. Refer to Section 3.3 for additional information.
Subjects in the multiple dose cohorts (Cohorts 3 through 5 and Cohort 7) will be confined to
the clinic from the day prior to dosing and through completion of Day 5 evaluations
(minimum of 96 hours post first dose administration), and 48 hours after the second dose
administration.  Subjects will return for outpatient follow-up visits per the Schedule of 
Activities (SoA) Table C.

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Throughout the study, adverse events (AEs) will be solicited, with specific attention to
infusion and injection site reactions (ISR) and those linked to immune reactions.  ADA
responses will be monitored from samples collected at baseline and at the additional times
post-dose as specified in the SoA.  Samples found to be positive in the ADA assay will be
further evaluated for neutralizing antibody (NAb) activity. Subjects having an unresolved 
adverse event that is possibly related to an ADA immune response will be asked to return for 
extended follow-up visit(s) at up to 3 month intervals beyond the last follow-up visit for up to 
12 months after last drug administration or until the adverse event or its sequelae resolve or 
stabilize at a level acceptable to the investigator and Sponsor concurs with the investigator’s 
assessment (see SoA). Subjects in any cohort may be confined beyond the period defined in 
the schedule of activities at the discretion of the investigator to accommodate the frequency
of required follow-up.  Subjects who are withdrawn from study for reasons other than safety
may be replaced at the discretion of the sponsor.
If operational logistics or safety analysis prohibits any of the pre-specified cohorts from 
receiving their second dose (eg, required safety or PK data are not available in time for the 
second dose) as planned for Cohorts 3-5 or Cohort 7, or the Sponsor determines not to 
proceed with all multiple dose cohorts based upon the review of emerging data, the affected
cohort(s) will return for outpatient follow-up visits per the SoA Table B. Additional subjects
may be randomized into the following cohorts (Cohorts 10-12) as needed to complete the
multiple dose portion of the study. The additional multiple dose cohorts would not be
randomized until the dosing criteria for multiple dose cohorts (see Section 3.3) were
completed:

Cohort 10 (n=8): 100 mg active (n=6) or placebo (n=2), IV x 2 doses.

Cohort 11 (n=8): 300 mg active (n=6) or placebo (n=2), IV x 2 doses.

Cohort 12 (n=8): 1000 mg active (n=6) or placebo (n=2), IV x 2 doses.
The additional multiple dose cohorts would follow the SoA Tables A and C.
3.1.2. Part 2:
One or more cohorts of CRSwNP patients will receive a single dose of PF-06817024.
Randomization will occur after safety data from Day 8 and PK data through at least Day 5 of
the same or higher dose in Part 1 of the study has been reviewed and deemed safe.

Cohorts 8 and 9: Subjects in each cohort will be randomized in either a 1 : 1 or 2 : 1 
(PF-06817024: placebo) ratio, depending on the number of cohorts and the emerging 
data. Up to approximately 10 active (per dose) and approximately 15 placebo 
(overall) subjects will be enrolled in Part 2 for a planned total of up to approximately 
35 subjects.

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•
Within 28 days of successful completion of the screening process, eligible CRSwNP 
patients will be admitted into the clinic approximately 1 day prior to dosing and are 
required to remain in the clinic through completion of Day 2 evaluations. Patients
will return for outpatient follow-up visits per SoA Table D.
3.1.3. Part 3
•
Part 3 will consist of a single cohort of subjects with moderate to severe AD 
(Cohort 13). Approximately 20 subjects in this cohort will be randomized to receive 
PF-06817024 or placebo in a 3: 1 ratio (PF-06817024: placebo). Additional subjects 
up to a total of approximately 32 may be enrolled in a 3: 1 ratio (PF-06817024: 
placebo) 
 Subjects in this cohort 
randomized to PF-06817024 will receive a planned dosing regimen consisting of a 
600 mg IV loading dose followed by 3 doses of 300 mg IV every 4 weeks.
•
Within 42 days of successful completion of the screening process, eligible subjects 
will have baseline assessments performed, be randomized into the study, and receive 
the first dose of study drug. Subjects will return for follow-up visits as indicated in 
the SoA Table E. Due to the expected duration of the visits at which investigational
product is administered, namely at Week 0 (Day 1), Week 4 (Day 29), Week 8 
(Day 57), and Week 12 (Day 85), at the discretion of the Investigator, pre-dose 
activities (as specified in SOA Table E footnote “b” and Section 6.2) on Day 1, 
Day 29, Day 57, Day 85 may be performed on the preceding day (ie, on Day 0, 
Day 28, Day 56, Day 84) as inpatient in clinical site or outpatient.
3.2. Dose Escalation and Stopping Rules (Part 1)
During the SAD period, escalation to subsequent dose levels will occur following the
sponsor’s review of the available safety data from at least 4 subjects receiving active 
treatment and 1 receiving placebo through at least study Day 8 and PK data through at least
Day 5 from the current cohort. The first dose of Cohort 7 (the SC cohort) can be 
administered after safety/tolerability data from at least 4 subjects receiving active treatment 
and 1 receiving placebo through Day 8 and PK data through Day 5 of a same or higher IV 
dose that has been reviewed and considered to be safe. The cumulative safety, PK and 
immunogenicity data available from previous cohorts will also be reviewed.  There will be a
minimum of 10 days between cohorts for dose escalation. Dose escalation stopping rules
will be used to determine whether the maximum tolerated dose has been attained.  Dose
escalation may be stopped if it is determined that the limits of safety and/or tolerability have
been reached.  This decision will be made after a discussion takes place between the Sponsor
study team and the investigator.  The Sponsor study team may not overrule the investigators’
decision to stop dose escalation.  If dose escalation is stopped due to any of the criteria noted 
below, additional cohorts may receive the same or lower doses of the investigational
compound.
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Criteria for terminating dose escalation:

If 50% or more of the subjects receiving active drug at a given dose level (but not
placebo subjects) develop similar clinically significant laboratory, electrocardiogram
(ECG) or vital signs abnormalities, or severe adverse events (AEs) in the same organ
class, indicating dose-limiting intolerance.

Dosing will be paused for any treatment emergent serious adverse event (SAE) that
occurs in a subject receiving active treatment until causality is fully assessed by the
principal investigator (PI) and Sponsor.  Dosing may resume if the SAE is determined
to be not drug-related by the PI and Sponsor. If the SAE is determined to be either
drug-related or unknown, dosing will either cease, or the SAE will be evaluated by
the sponsor’s protocol review committee (or similar group of reviewers) which is
independent of the study team and investigators.  If the protocol review committee
determines that dosing may resume, a plan that mitigates risks to subjects with the
resumption of dosing will be implemented.  Such a plan could include a revision of
inclusion/exclusion criteria, repeating or reducing the dose, or adding appropriate
safety monitoring.

It is determined that the limit of safety and/or tolerability has been reached.  This
decision will be made following discussions between the study team and the
investigator.

Other findings that, at the discretion of the study team and investigator, indicate that
dose escalation should be halted.

If, at any dose level, the average exposure for the treatment group reaches or exceeds
the PK stopping limit of Cav of 442.5 g/mL.

If, based on the observed data, the group average Cav of the next planned dose is
projected to exceed 442.5 g/mL, the PK stopping limit, that dose will not be
explored.  Modified doses may be explored if they are not expected to exceed PK
stopping criteria.
Progression to the next dose will occur if the previous doses were well tolerated and after
satisfactory review of the available safety and pharmacokinetic data.
3.3. Dosing Criteria for Multiple Dose Cohorts (Part 1)
Initiation of the multiple dose safety/tolerability and PK evaluation is planned to begin at the
100 mg IV dose level in Cohort 3 (Day 32, second dose). The Sponsor and PI will review 
criteria in Table 3 prior to progression to the second dose within Cohorts 3-5, 7 and 10-12 if 
implemented.

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Table 3.
Second Dose Prerequisites
Study Cohort
Second Dose Prerequisites
1
N/A (single dose cohort)
2
N/A (single dose cohort)
3 (10 if 
implemented)
Day 8 safety and Day 5 PK data from first dose in Cohort 4*
Cumulative safety and PK from Cohorts 1-3
4 (11 if 
implemented)
Day 8 safety and Day 5 PK data from first dose in Cohort 5*
Cumulative safety and PK data from Cohorts 1-4
Available safety through at least 7 days following second dose of Cohort 3 (Cohort 10 if 
implemented)*
5 (12 if 
implemented)
Day 8 safety and Day 5 PK data from first dose in Cohort 6*
Cumulative safety and PK data from Cohorts 1-5
Available safety through at least 7 days following second dose of Cohort 4 (Cohort 11 if 
implemented)*
6
N/A (single dose cohort)
7
First SC dose has been reviewed and considered safe
Day 8 safety and Day 5 PK data from the same or higher IV dose *
8
N/A (single dose cohort)
9
N/A (single dose cohort)
*at least 4 subjects receiving active treatment and 1 receiving placebo
4. SUBJECT SELECTION
This study can fulfill its objectives only if appropriate subjects are enrolled.  The following
eligibility criteria are designed to select subjects for whom participation in the study is
considered appropriate.  All relevant medical and nonmedical conditions should be taken into
consideration when deciding whether a particular subject is suitable for this protocol.
4.1. Inclusion and Exclusion Criteria
Subject eligibility should be reviewed and documented by an appropriate member of the
investigator’s study team before subjects are included in the study.
4.1.1. Inclusion Criteria (Parts 1 and 2) 
Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the
study:
1. Part 1: Healthy female subjects of non-childbearing potential and/or male subjects
who, at the time of screening, are between the ages of 18 and 55 years, inclusive.  
Healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead ECG or clinical laboratory tests.
Part 2: Female subjects of non-childbearing potential, female subjects of childbearing 
potential who have a documented bilateral tubal ligation or bilateral salpingectomy
and/or male subjects, who at the time of screening, are between the ages of 18 and
65 years, inclusive.
Parts 1 and 2: Female subjects of non-childbearing potential must meet at least one
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a.
Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause and a serum follicle-stimulating hormone (FSH) level
confirming the post-menopausal state.
b. Have undergone a documented hysterectomy and/or bilateral oophorectomy.
c.
Have medically confirmed ovarian failure to be reviewed with the Sponsor.
All other female subjects (including females with tubal ligations) will be considered
to be of childbearing potential.
2. Evidence of a personally signed and dated informed consent document indicating
that the subject has been informed of all pertinent aspects of the study.
3. Subjects who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, and other study procedures.
4. Quantiferon- Tuberculosis (TB) test and chest X-ray with no evidence of current,
active TB or previous inactive TB, general infections, heart failure, malignancy, or
other clinically significant abnormalities taken at Screening or within 3 months
prior to Screening.  Chest X-ray to be read by a qualified radiologist.
5. Part 1 (Cohorts 1 through 4 only): Subjects who are Phadiatop positive (historical 
positive test results with appropriate documentation are acceptable).  (Note: any 
replacement subjects for Cohorts 1 through 4 are exempt from this inclusion 
criteria).
6. Part 1 (Cohorts 1 through 4 only): Subjects with at least one test result of IgE
50 kU/L (120 ng/mL) within the past 6 months. (Note: any replacement subjects 
for Cohorts 1 through 4 are exempt from this inclusion criteria).
7. Part 1: Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight
>50 kg (110 lbs).
Part 2: Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg
(110 lbs).
8. Part 2 only: A minimum bilateral Nasal Polyp Score (NPS) of 5 out of a maximum
score of 8 (with a unilateral score of at least 2 for each nostril) from the screening 
endoscopy (see Appendix 3).
9. Part 2 only: Presence of at least two of the following symptoms prior to screening:
nasal blockade/obstruction/congestion; nasal discharge (anterior/posterior nasal
drip); facial pain/pressure; reduction or loss of smell.

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4.1.1.1. Inclusion Criteria for Part 3 only
1. Evidence of a personally signed and dated informed consent document indicating 
that the subject has been informed of all pertinent aspects of the study. 
2. Male or female subjects, who at the time of screening, are between the ages of
18 and 75 years, inclusive. Subjects above 70 years need to be discussed with the 
sponsor.
Female subjects of non-childbearing potential must meet at least one of the
following criteria:
a.
Achieved postmenopausal status, defined as follows: cessation of regular menses 
for at least 12 consecutive months with no alternative pathological or 
physiological cause and a serum follicle-stimulating hormone (FSH) level 
confirming the post-menopausal state.
b. Have undergone a documented hysterectomy and/or bilateral oophorectomy.
c.
Have medically confirmed ovarian failure to be reviewed with the sponsor.
All other female subjects (including females with tubal ligations) will be considered
to be of childbearing potential.
3. All female subjects of child bearing potential and male subjects who, in the opinion 
of the investigator, are able to father children and are sexually active and whose 
partners are at risk for pregnancy must agree to use at least one highly effective 
method of contraception consistently and correctly for the duration of the active 
treatment period (date of first dose) through the end of the study (until discharged 
from the study). Additionally, males must use a condom to prevent possible 
transmission of study drug to a partner. See Section 4.3.2.4.
4. Negative Quantiferon TB (QFT-TB) Gold at time of screening. 
5. Chest X-ray with no evidence of general infections (including evidence of active 
TB), heart failure, malignancy, or other clinically significant abnormalities taken at 
Screening or within 3 months prior to Screening. Chest X-ray to be read by a 
qualified radiologist.
6. Body Mass Index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg 
(110 lbs).
7. Must have the following atopic dermatitis criteria:
a.
Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic 
eczema) for at least 1 year prior to Day 1 and have the diagnosis of AD confirmed 
(Hanifin and Rajka criteria of AD52 refer to Appendix 16) at the Screening visit.

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b. Either have had an inadequate response to treatment with topical medications (for 
at least 4 consecutive weeks within 1 year of the first dose of the study drug), OR
Have a documented reason why topical treatments otherwise have been medically
inadvisable (eg, because of important side effects or safety risks) within the last 
year.
c.
Have moderate to severe AD (defined as having an affected BSA (captured as 
part of EASI) 10%, IGA 3, and EASI 12 at the screening and baseline visits).
8. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, 
sun lamps, or other ultraviolet light sources during the study.
9. If receiving permitted concomitant medications for any reason other than AD, must 
be on a stable regimen, which is defined as not starting a new drug or changing 
dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Subjects 
must be willing to stay on a stable regimen during the duration of the study.
10. Subjects who are willing and able to comply with all scheduled visits, treatment 
plan, laboratory tests, and other study procedures.
4.1.2. Exclusion Criteria (Parts 1 and 2)
Subjects with any of the following characteristics/conditions will not be included in the 
study:
1. Part 1: Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, autoimmune, or
neurologic disease (including drug allergies, but excluding untreated,
asymptomatic, seasonal allergies at the time of dosing).
Part 2: Evidence or history of clinically significant hematological, renal, endocrine,
gastrointestinal, cardiovascular, hepatic, psychiatric, autoimmune, or neurologic
disease.
2. Subjects with a history of or current positive results for any of the following
serological tests:

Part 1 (Cohorts 1 through 4 only): Hepatitis B surface antigen (HBsAg) or
Hepatitis B core antibody (HBcAb).

Part 1 and Part 2: anti-Hepatitis C antibody (HCV Ab) or human
immunodeficiency virus (HIV).

Part 1 (Cohorts 5 and later) and Part 2: Subjects will be screened for Hepatitis B 
virus infection and will be excluded if positive for Hepatitis B surface antigen 
(HBsAg). Subjects with HBsAg negative testing but who test positive for 
hepatitis B core antibody (HBcAb) must have further testing for hepatitis B 

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surface antibody (HBsAb). If HBsAb is negative, the subject will be excluded 
from the study.
3. Subjects with a history of anaphylaxis.  Part 2 only: subjects with only sensitivity 
and/or anaphylaxis to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
may be enrolled, if in the opinion of the investigator, the subject is aware of the 
hypersensitivity and avoids aspirin/NSAIDs. 
4. History of recent active infections within 28 days prior to the screening visit.  
Part 2 only: subjects with a history of sinus infections that have not required
antibiotic treatment within 28 days prior to the screening visit are permitted to enter 
the study. Note: patients may be rescreened after infection resolves. 
5. Subjects with a fever within 7 days prior to dosing.
6. Recent exposure to live vaccines within 28 days of the screening visit.
7. Treatment with an investigational drug within 28 days (or as determined by the
local requirement) or 5 half-lives preceding the first dose of study treatment
(whichever is longer).
8. Part 1 and Part 2: Pregnant female subjects, breastfeeding female subjects, male
subjects with partners currently pregnant, or male or female subjects pursuing 
artificial reproductive technologies including but not limited to sperm/egg donation.
Part 1: Female subjects of childbearing potential, male subjects able to father children 
who are unwilling or unable to use a highly effective method of contraception as 
outlined in this protocol for the duration of the study (see Section 4.3.1.5, Lifestyle
Guidelines).
Part 2: Female subjects of childbearing potential unless they have a documented 
bilateral tubal ligation or bilateral salpingectomy, male subjects able to father children 
who are unwilling or unable to use a highly effective method of contraception as 
outlined in this protocol for the duration of the study (see Section 4.3.1.5, Lifestyle
Guidelines).
9. A positive urine drug screen (see Section 7.1.1.1).
10. History of regular alcohol consumption exceeding 7 drinks/week for females or
14 drinks/week for males; (1 drink = 5 ounces of wine or 12  ounces of beer or
1.5 ounces of hard liquor) within 6 months of Screening.
11. Part 1: Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg
(diastolic), following at least 5 minutes of supine rest.  If blood pressure (BP) is
140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should be repeated two
more times and the average of the three BP values should be used to determine the
subject’s eligibility.

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Part 2: Screening supine blood pressure 160 mm Hg (systolic) or 100 mm Hg 
(diastolic), following at least 5 minutes of supine rest.  If blood pressure (BP) is
160 mm Hg (systolic) or 100 mm Hg (diastolic), the BP should be repeated two
more times and the average of the three BP values should be used to determine the
subject’s eligibility.
12. Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval
>120 msec.  If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should
be repeated two more times and the average of the three QTc or QRS values should
be used to determine the subject’s eligibility.
13. Part 1 only: Use of prescription or nonprescription drugs and dietary supplements
within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study
treatment.  As an exception, acetaminophen/paracetamol may be used at doses of
1 g/day.  Limited use of non-prescription medications that are not believed to
affect subject safety or the overall results of the study may be permitted on a
case-by-case basis following approval by the sponsor.
Herbal supplements and hormone replacement therapy must be discontinued at least
28 days prior to the first dose of study treatment.
14. Part 1 only: Subjects with ANY of the following abnormalities in clinical
laboratory tests at screening, as assessed by the study-specific laboratory and
confirmed by a single repeat, if deemed necessary:

Aspartate transaminase (AST)/serum glutamic oxaloacetic transaminase (SGOT)
or alanine transaminase (ALT)/serum glutamic pyruvic transaminase (SGPT)
1.5x upper limit of normal (ULN);

Total bilirubin 1.5 x ULN; subjects with a history of Gilbert's syndrome may
have a direct bilirubin measured and would be eligible for this study provided the
direct bilirubin is ULN.
15. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or
more within 56 days prior to dosing.
16. Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by
the investigator, or subjects who are Pfizer employees directly involved in the
conduct of the study.
17. Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational
product administration or may interfere with the interpretation of study results and,
in the judgment of the investigator, would make the subject inappropriate for entry
into this study.

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The following additional exclusion criteria for Part 2 only:
18. Subjects with a history of allergic reaction to topical lidocaine or topical
oxymetazoline.
19. Subjects taking topical oxymetazoline (outside of study procedures: nasal
endoscopy).
20. Subjects treated with anti-immunoglobulin E (IgE) therapy (omalizumab) or 
anti-IL-5 (mepolizumab) within 130 days prior to Screening.
21. Subjects receiving systemic corticosteroids within 6 weeks before screening or
scheduled to receive systemic corticosteroids during the study period for another
condition. Subjects receiving doses of depot preparations of parenteral 
corticosteroids within 6 weeks of the predicted end of release of the corticosteroid 
from the depot are excluded. See Exclusion Criteria 28 for additional asthma 
exacerbation corticosteroid restrictions. 
22. Subjects taking leukotriene antagonists/modifiers unless subject has been taking 
such an agent continuously for at least 28 days prior to Screening.
23. Subjects taking monoclonal antibody (mAB) and/or immunosuppressive treatment, 
excluding specific agents discussed above.
24. Subjects with a history of helminthic infestation or resident/recent travel from an
endemic area within 90 days prior to Screening.
25. Subjects with a sino-nasal outcome test (SNOT-22) <7.
26. Subjects who have undergone any nasal surgery (including polypectomy) within
6 months before screening or have had more than 5 sinonasal surgeries in the past
10 years of which no more than 2 were surgeries with major changes to the lateral
wall structure of the nose.
27. Subjects with a history of prior radiation exposure for research purposes within the 
past year where participation in this study would place them over the FDA limits 
for annual radiation exposure. This guideline is an effective dose of 5 rem received 
per year. 
28. Subjects with a history of asthma having any of the following:

Forced Expiratory Volume (FEV1) <60% predicted as documented via spirometry 
(acceptable from up to 3 months prior to screening).

An asthma exacerbation requiring systemic (oral and/or parenteral) steroid
treatment within 2 months prior to screening or requiring hospitalization for
>24 hours for treatment of asthma within 3 months prior to screening.

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
Are on a dose of greater than 1000 g fluticasone, or an equivalent inhaled
corticosteroid, per day.

A supplemental oxygen requirement.

A diagnosis of allergic fungal sinusitis/allergic fungal rhinosinusitis.
4.1.2.1. Exclusion Critieria Part 3 only
1. Pregnant female subjects, breastfeeding female subjects, male subjects with partners 
currently pregnant, or male or female subjects pursuing artificial reproductive 
technologies including but not limited to sperm/egg donation (see Section 4.3.2.4, 
Lifestyle Guidelines). 
Female subjects of childbearing potential, male subjects able to father children who 
are unwilling or unable to use at least one highly effective method of contraception 
as outlined in this protocol for the duration of the study (see Section 4.3.2.4, 
Lifestyle Guidelines).
2. Other acute or chronic medical or psychiatric condition including recent (within the 
past year) or active suicidal ideation or behavior or laboratory abnormality that may 
increase the risk associated with study participation or investigational product 
administration or may interfere with the interpretation of study results and, in the 
judgment of the investigator, would make the subject inappropriate for entry into 
this study.
3. Have any malignancies or have a history of malignancies with the exception of 
adequately treated or excised non-metastatic basal cell or squamous cell cancer of 
the skin, or cervical carcinoma in situ.
4. Have a history of any lymphoproliferative disorder such as Epstein Barr Virus 
(EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or 
signs and symptoms suggestive of current lymphatic or lymphoid disease.
5. Currently have active forms of other inflammatory skin diseases.
6. Have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the 
time of Day 1 that would interfere with evaluation of atopic dermatitis or response 
to treatment.
7. Have a history of systemic infection requiring hospitalization, parenteral 
antimicrobial therapy, or as otherwise judged clinically significant by the 
investigator within 6 months prior to Day 1 (for exception regarding latent 
Tuberculosis (TB) infection see Inclusion Criterion 4 and 5 in Section 4.1.1.1 or 
skin infections that lead to hospitalizations see Exclusion Criterion 8).

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8. Have active chronic or acute skin infection (except latent TB infection see Inclusion 
Criterion 4 and 5 in Section 4.1.1.1) requiring treatment with systemic antibiotics, 
antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to 
Day 1, or superficial skin infections within 1 week prior to Day 1.  NOTE: potential 
subjects may be rescreened after infection resolves.
9. Subjects with a history of helminthic infestation or resident/recent travel from an 
endemic area within 90 days prior to Screening
10. Have a known immunodeficiency disorder or a first-degree relative with a 
hereditary immunodeficiency.
11. Have undergone significant trauma or major surgery within 1 month of the first 
dose of study drug.
12. Subjects will be screened for Hepatitis B virus infection and will be excluded if 
positive for Hepatitis B surface antigen (HBsAg).  Subjects with HBsAg negative 
testing but who test positive for hepatitis B core antibody (HBcAb) must have 
further testing for hepatitis B surface antibody (HBsAb).  If HBsAb is negative, the 
subject will be excluded from the study
13. Subjects positive for HCVAb are to be excluded unless known to have been treated 
with a known curative therapy and negative for HCV 
.
14. Human immunodeficiency virus (HIV) positive subjects will be excluded.
15. Recent exposure to live or attenuated vaccines within 28 days of the screening visit.
16. Subjects with a history of anaphylaxis with the following exceptions: subjects with 
sensitivity and/or anaphylaxis only to a single, avoidable allergen (eg, aspirin, 
penicillin, sulfadrugs, nonsteroidal anti-inflammatory drugs (NSAIDs), peanuts) 
may be enrolled, if in the opinion of the investigator, the subject is aware of the 
hypersensitivity and avoids -the problematic allergen. Subjects must carry 
appropriate treatment for anaphylaxis and must know how to manage the 
anaphylactic reactions.
17. Subjects with a fever within 7 days prior to dosing.
18. A positive urine drug screen except marijuana where use is permitted by local law 
and regulations (see Section 7.1.1.1).
19. History of regular alcohol consumption exceeding 7 drinks/week for females or
14 drinks/week for males; (1 drink = 5 ounces of wine or 12  ounces of beer or
1.5 ounces of hard liquor) within 6 months of Screening.
CCI

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20. Screening supine blood pressure 160 mm Hg (systolic) or 100 mm Hg (diastolic), 
following at least 5 minutes of supine rest.  If blood pressure (BP) is 160 mm Hg
(systolic) or 100 mm Hg (diastolic), the BP should be repeated two more times
and the average of the three BP values should be used to determine the subject’s
eligibility.
21. Screening supine 12-lead ECG demonstrating corrected QT (QTc) >450 msec or a
QRS interval >120 msec.  If QTc exceeds 450 msec, or QRS exceeds 120 msec, the
ECG should be repeated two more times and the average of the three QTc or QRS 
values should be used to determine the subject’s eligibility.
22. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or 
more within 56 days prior to dosing.
23. Treatment with an investigational drug within 28 days (or as determined by the 
local requirement) or 5 half-lives preceding the first dose of study treatment 
(whichever is longer).
Any investigational or experimental therapy taken or procedure performed for AD, 
psoriasis, psoriatic arthritis or rheumatoid arthritis in the previous 1 year should be 
discussed with the Pfizer Medical Monitor (or designee).  Subjects cannot 
participate in studies of other investigational or experimental therapies or 
procedures at any time during their participation in this study.
24. Have received any of the following treatment regiments with the specified 
timeframes outlined below:

Systemic Corticosteroids:

Subjects receiving systemic corticosteroids within 4 weeks prior to first dose 
of study drug or scheduled to receive systemic corticosteroids during the 
study period for another condition.  Subjects receiving doses of depot 
preparations of parenteral corticosteroids within 6 weeks of the predicted 
end of release of the corticosteroid from the depot are excluded.  See 
Exclusion Criteria 28 for additional asthma exacerbation corticosteroid 
restrictions. 

Leukotriene antagonists/modifiers:

Asthmatic subjects taking stable doses of leukotriene antagonists/modifiers 
for at least 28 days prior to first dose of study drug may be included.

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
Any prior or current use of Anti-IL-33 targeted therapies is exclusionary.

Within 6 months of first dose of study drug:

Anti-IL-4 and/or IL-13 targeted therapies (eg, lebrkizumab, tralokinumab)
except for dupilumab (within 4 months of first dose of study drug).

mepolizumab, reslizumab.

Within 12 months of first dose of study drug:

Benralizumab.

Within 6 months of first dose of study drug:

Any cell-depleting agents including but not limited to rituximab: within 
6 months of first dose of study drug or 5 half-lives (if known), whichever is 
longer, or until lymphocyte count returns to normal, whichever is longer.

Within 12 weeks of first dose of study drug:

Any Janus Kinase (JAK) inhibitors, including any clinical studies in which a 
JAK inhibitor was a possible study treatment.

Other biologics: within 12 weeks of first dose of study drug or 5 half-lives 
(if known), whichever is longer.

Within 6 weeks of first dose of study drug:

Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug:

Use of oral immune suppressants (eg, cyclosporine A [CsA], azathioprine, 
MTX, Celcept, mycophenolate-mofetil, Interferon-gamma (IFN-) within 
4 weeks of first dose of study drug or within 5 half-lives (if known), 
whichever is longer.

Oral or topical phosphodiesterase (PDE) 3 or PDE4 anatgonists (eg, 
apremilast, crisaborole); oral/topical histamine H4 antagonists: within 
28 days or 5 half-lives whichever is longer prior to first dose of study drug.

Phototherapy (NB-UVB) or broad band phototherapy.

Regular use (more than 2 visits per week) of a tanning booth/parlor.

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
Within 1 week of first dose of study drug:

Topical treatments that could affect atopic dermatitis (eg, corticosteroids, 
calcineurin inhibitors, tars, antibiotic creams, topical antihistamines).
Note: Corticosteroid inhalers at allowed doses (see Exclusion criteria 28) and 
intranasal sprays are allowed for stable asthma and allergic rhinitis subjects
respectively.

Herbal medications with known anti-inflammatory effects or otherwise 
taken for AD.
25. Require treatment with prohibited concomitant medication(s) (Section 5.9.2) or 
have received a prohibited concomitant medication within the specified time prior 
to Day 1.
26. Subjects who are investigational site staff members directly involved in the conduct 
of the study and their family members, site staff members otherwise supervised by
the investigator, or subjects who are Pfizer employees directly involved in the
conduct of the study.
27. At Screening Visit, if there are “yes” answers on items 4, 5 in the past year or on 
any question in the suicidal behavior section of the Columbia-Suicide Severity 
Rating Scale (C-SSRS) in the past 6 months, the subject will not be included in the 
study
28. Subjects with a history of inadequately controlled or uncontrolled asthma having 
any of the following:

Forced Expiratory Volume (FEV1) <60% predicted as documented via spirometry 
(acceptable from up to 3 months prior to screening).

An asthma exacerbation requiring systemic (oral and/or parenteral) steroid 
treatment within 2 months prior to screening or requiring hospitalization for 
>24 hours for treatment of asthma within 3 months prior to screening.

Are on an inhaled dose of greater than 1000 g fluticasone, or an equivalent 
inhaled corticosteroid, per day.

A supplemental oxygen requirement.

A diagnosis of allergic fungal sinusitis/allergic fungal rhinosinusitis.

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4.2. Randomization Criteria
Subjects will be randomized into the study provided they have satisfied all subject eligibility 
criteria.
Part 1
Subjects will be randomized into the study provided they have satisfied all subject eligibility
criteria. Subjects will be randomized within each cohort to receive either PF-06817024 (PF)
or placebo (Pbo) as described in Section 3.1.  The randomization ratio in the study will be
6:2 (PF:Pbo) for Cohorts 1 through 7.  If additional Cohorts 10 through 12 are required, the
randomization ratio in these cohorts will also be 6:2 (PF:Pbo).
Part 2
Subjects in Cohorts 8 and 9 will be randomized in either a 1: 1 or 2 : 1 (PF-06817024: 
placebo) ratio, depending on the number of cohorts and the emerging data. Up to 
approximately 10 active (per dose) and approximately 15 placebo (overall) subjects will be 
enrolled in Part 2.
Part 3
Subjects will be randomized in an approximately 3: 1 (PF-06817024: placebo) ratio. 
Approximately 20 subjects are planned to be enrolled into a single cohort in Part 3.
Additional subjects up to a total of approximately 32 may be enrolled in a 3: 1 ratio 
(PF-06817024: placebo) based on analysis of emerging safety, PK, 
 data.
4.3. Lifestyle Guidelines
4.3.1. Parts 1 and 2
The following guidelines are provided:
4.3.1.1. Meals and Dietary Restrictions
•
Subjects must abstain from all food and drink (except water) at least 4 hours prior to
any safety laboratory evaluations and 10 hours prior to the collection of the pre-dose
pharmacokinetic sample.  Water is permitted without restriction.
•
Non-caffeinated drinks may be consumed with meals and the evening snack during
confinement at the clinical research unit (CRU).
•
Lunch will be provided as early as 2 hours after the start of infusion or SC injections.
•
Dinner will be provided approximately 7 to 8 hours after the start of infusion or SC
injections.
•
An evening snack may be permitted.
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
While confined, the total daily nutritional composition should be approximately
55% carbohydrate, 30% fat and 15% protein.  The daily caloric intake per subject
should not exceed approximately 3200 kcal.
4.3.1.2. Alcohol, Caffeine and Tobacco

Subjects will abstain from alcohol for 24 hours prior to admission to the CRU and
continue abstaining from alcohol during clinical confinement at the CRU. All 
subjects may undergo an alcohol breath test or blood alcohol test at the discretion of
the investigator.

Subjects will abstain from caffeine-containing products for 24 hours prior to the start
of dosing and during clinical confinement at the CRU and 2 hours prior to follow-up 
visits.

Subjects will abstain from the use of tobacco- or nicotine-containing products for
24 hours prior to dosing and during confinement in the research unit.
4.3.1.3. Activity

Subjects will be confined to the procedure room for the first 4 hours after dosing
during continuous cardiac monitoring, except to use the bathroom or for meals.  After
this, if the equipment setup allows, subjects may be ambulatory during the ECG
monitoring period, but should not engage in strenuous activities.  If equipment does
not allow ambulation, appropriate accommodations will be made by the study site to
facilitate continuous monitoring (eg, bedside urinals should be provided to
accommodate subjects’ excretory needs).

Subjects will abstain from strenuous exercise (eg, heavy lifting, weight training,
calisthenics, aerobics) for at least 48 hours prior to each blood collection for clinical
laboratory tests.  Walking at a normal pace will be permitted.
4.3.1.4. Travel

Subjects should be informed that travel to areas with endemic helminthes (including
but not limited to Southeast and Southwest Asia, South America, and Africa) must
not be planned for at least 6 months after the last dose of PF-06817024.
4.3.1.5. Contraception
All male subjects who, in the opinion of the investigator, are able to father children and are
sexually active and whose partners are at risk for pregnancy (Part 1 and Part 2) must agree to
use a highly effective method of contraception consistently and correctly for the duration of
the active treatment period (date of first dose) through the end of the study (until discharged
from the study).  The investigator or his or her designee, in consultation with the subject, will
select/confirm an appropriate method of contraception for the individual subject and his
partner from the permitted list of contraception methods (see below) and instruct the subject
in its consistent and correct use.  Subjects need to affirm that they meet the criteria for the

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correct use of at least 1 of the selected methods of contraception.  The investigator or his or
her designee will discuss with the subject the need to use highly effective contraception
consistently and correctly according to the schedule of activities and document such
conversation in the subject’s chart.  In addition, the investigator or his or her designee will
instruct the subject to call immediately if the selected contraception method is discontinued
or if pregnancy is known or suspected in the subject or the subject’s partner.
Highly effective methods of contraception are those that, alone or in combination, result in a
failure rate of less than 1% per year when used consistently and correctly (ie, perfect use) and
include the following:
1. Established use of hormonal methods of contraception associated with inhibition of 
ovulation (eg, oral, inserted, injected, transdermal, or implanted) provided the male 
subject’s partner plans to remain on the same treatment throughout the entire study
and has been using that hormonal contraceptive for an adequate period of time to
ensure effectiveness.
2. Correctly placed copper-containing intrauterine device (IUD).
3. Male condom or female condom used WITH a separate spermicide product (ie,
foam, gel, film, cream, or suppository).  For countries where spermicide is not 
available or condom plus spermicide is not accepted as highly effective 
contraception, this option is not appropriate.
4. Male sterilization with absence of sperm in the postvasectomy ejaculate.
5. Bilateral tubal ligation / bilateral salpingectomy or bilateral tubal occlusive
procedure (provided that occlusion has been confirmed in accordance with the
device’s label).
6. Female partner who meets the criteria for non-childbearing potential must meet at 
least one of the following criteria:
a.
Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause and a serum follicle-stimulating hormone (FSH) level
confirming the post-menopausal state.
b. Have undergone a documented hysterectomy and/or bilateral oophorectomy.
c.
Have medically confirmed ovarian failure.
NOTE: Women of childbearing potential are excluded from Part 1 of this study.  For Part 2 
of this study, female subjects may be of childbearing potential provided that they have 
undergone a documented bilateral tubal ligation or bilateral salpingectomy.

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4.3.2. Part 3
4.3.2.1. Meals and Dietary Restrictions

Subjects must abstain from all food and drink (except water) at least 4 hours prior to 
any safety laboratory evaluations. Water is permitted without restriction.
4.3.2.2. Alcohol, Caffeine and Tobacco

Non-caffeinated drinks may be consumed with meals.

Subjects will abstain from alcohol for 24 hours prior to all clinic vists. All subjects 
may undergo an alcohol breath test or blood alcohol test at the discretion of the 
investigator.

Subjects will abstain from caffeine-containing products for 24 hours prior to all visits
till the completion of infusion of the IP and necessary activities such as ECG, vitals, 
respiratory rate (RR). Moderate consumption (eg, 1 cup (8 oz) of coffee/tea, 12 oz of 
caffeinated soda, but not including highly caffeinated beverages such as “Red Bull”) 
may be allowed after the completion of these activities until the end of the visit.

Subjects will abstain from the use of tobacco- or nicotine-containing products for 
6 hours prior to all clinic visits and till the completion of the blood draws. 
4.3.2.3. Activity

Subjects will abstain from strenuous exercise (eg, heavy lifting, weight training, 
calisthenics, aerobics) for at least 48 hours prior to each blood collection for clinical 
laboratory tests.  Walking at a normal pace will be permitted.
4.3.2.4. Contraception
All fertile male subjects and female subjects who are of childbearing potential who are, in the 
opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) 
must agree to use at least one highly effective method of contraception consistently and 
correctly for the duration of the active treatment period (date of first dose) through the end of 
the study (until discharged from the study). The investigator or his or her designee, in 
consultation with the subject, will confirm that the subject has selected an appropriate 
method of contraception for the individual subject and his or her partner(s) from the 
permitted list of contraception methods (see below) and will confirm that the subject has 
been instructed in its consistent and correct use.  At time points indicated in the Schedule of 
Activities, the investigator or designee will inform the subject of the need to use at least one 
highly effective contraception consistently and correctly and document the conversation and 
the subject’s affirmation in the subject’s chart (subjects need to affirm their consistent and 
correct use of at least 1 of the selected methods of contraception).  In addition, the 
investigator or designee will instruct the subject to call immediately if the selected 
contraception method is discontinued or if pregnancy is known or suspected in the subject or 
partner.

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Highly effective methods of contraception are those that, alone or in combination, result in a 
failure rate of less than 1% per year when used consistently and correctly (ie, perfect use) and 
include the following:
1. Established use of hormonal methods of contraception associated with inhibition of 
ovulation (eg, oral, inserted, injected, implanted, transdermal), provided the subject or 
male subject’s female partner plans to remain on the same treatment throughout the 
entire study and has been using that hormonal contraceptive for an adequate period of 
time to ensure effectiveness. 
2. Correctly placed copper-containing intrauterine device (IUD). 
3. Male sterilization with absence of sperm in the postvasectomy ejaculate.
4. Bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusive procedure 
(provided that occlusion has been confirmed in accordance with the device’s label).
NOTE: Sexual abstinence, defined as completely and persistently refraining from all 
heterosexual intercourse (including during the entire period of risk associated with the 
study treatments) may obviate the need for contraception ONLY if this is the 
preferred and usual lifestyle of the subject.
Any consideration of using sexual abstinence as a contraception method must be 
discussed with the sponsor and will be decided on a case-by-case basis.
In addition to the use of at least one highly effective method of contraception by the 
male subject or his partner, male subjects must use a condom to prevent possible
transfer of study drug in seminal fluid.
For all subjects required to use contraception per protocol, the PI needs to document 
in the case report form (CRF), what form of contraception the subject (and/or partner) 
has agreed to use during the study. The selected and approved contraception method
must be used for a long enough period prior to dosing to ensure that the selected 
contraception method is effective at the time of the first dose of study drug.
At each subsequent study visit, a contraception check will be performed prior to the 
dosing of study drug (on dosing visits) to confirm that appropriate contraception has 
been used since the last study visit and to confirm what method will be used until the 
next study visit. The type of contraception used will be documented in the CRF for 
every visit. 
Pregnancy testing of female subjects of childbearing potential will be done at every 
visit and results from the testing will also be documented in the CRF.  In addition, 
pregnancy testing will also be done at home when the interval between study visits is 
greater than 1 month.

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4.3.2.5. Travel
•
Subjects should be informed that travel to areas with endemic helminthes (including 
but not limited to Southeast and Southwest Asia, South America, and Africa) should
not be planned for at least 6 months after the last dose of PF-06817024. Subjects 
traveling to such areas should take appropriate precautions (eg, avoiding walking 
barefooted, using protective clothing, etc) to the extent possible.
4.3.2.6. Other
•
On study visit days, showering or bathing is permitted prior to attending the study 
visit, but subjects should not apply emollients.
 
 
 
 
4.3.3. Rater Qualifications (Part 3)
Clinical evaluations of AD will be performed by an experienced and qualified dermatologist 
(board certified or equivalent).  An experienced and qualified non-dermatologist physician or 
experienced medical professional with experience in the conduct of AD clinical trials may be 
permitted to perform the clinical evaluations of atopic dermatitis when designated by primary 
site Investigator and agreed by Pfizer sponsor team. 
 
 
 
4.4. Sponsor’s Qualified Medical Personnel
The contact information for the sponsor's appropriately qualified medical personnel for the
study is documented in the study contact list located in the team SharePoint site.
To facilitate access to appropriately qualified medical personnel on study-related medical
questions or problems, subjects are provided with a contact card.  The contact card contains,
at a minimum, protocol and investigational compound identifiers, subject study numbers,
contact information for the investigational site, and contact details for a contact center in the
event that the investigational site staff cannot be reached to provide advice on a medical
question or problem originating from another healthcare professional not involved in the
subject’s participation in the study.  The contact number can also be used by investigational
CCI
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staff if they are seeking advice on medical questions or problems; however, it should be used
only in the event that the established communication pathways between the investigational
site and the study team are not available.  It is therefore intended to augment, but not replace,
the established communication pathways between the investigational site and the study team
for advice on medical questions or problems that may arise during the study.  For sites other
than a Pfizer CRU, the contact number is not intended for use by the subject directly, and if a
subject calls that number, he or she will be directed back to the investigational site.
5. STUDY TREATMENTS
For the purposes of this study, and per International Conference on Harmonization (ICH)
guidelines, investigational product is defined as a pharmaceutical form of an active
ingredient or placebo being tested or used as a reference in a clinical trial, including a
product with a marketing authorization when used or assembled (formulated or packaged) in
a way different from the approved form, or when used for an unapproved indication, or when
used to gain further information about an approved use (ICH E6 1.33).
5.1. Allocation to Treatment
The investigator will assign subject numbers to the subjects as they are screened for the
study.  Pfizer will provide a randomization schedule to the investigator and, in accordance
with the randomization numbers, the subject will receive the study treatment regimen
assigned to the corresponding randomization number.
5.2. Breaking the Blind
At the initiation of the study, the study site will be instructed on the method for breaking the
blind.  The method will be either a manual or an electronic process.  Blinding codes should
be broken only in emergency situations for reasons of subject safety.  Whenever possible, the
investigator or sub-investigator should consult with a member of the study team prior to
breaking the blind.  When the blinding code is broken, the reason must be fully documented
and entered on the case report form (CRF)/data collection tool (DCT). A data blinding plan
will be created prior to randomization and will be maintained throughout the course of the
study.
Blood specimens will be obtained from all subjects for pharmacokinetic analysis to maintain
the study blind at the investigator site.  Only the investigator site(s) staff and blinded study
monitor, if assigned, will be blinded to study treatment.  Other Pfizer personnel will be
unblinded to subject treatments in order to permit real-time interpretation of the safety and
pharmacokinetic data; and provide information necessary to potentially alter the dose
escalation sequence.  The blinded study monitor, if assigned, will remain blinded to treatment
until all monitoring for the study has been completed.  Specimens from subjects randomized
to placebo will not be routinely analyzed.  To minimize the potential for bias, treatment
randomization information will be kept confidential by Pfizer unblinded personnel and will
not be released to the blinded investigator or blinded investigator site personnel until the
study database has been locked or the investigator requests unblinding for safety reasons.

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5.3. Subject Compliance
Study treatment will be administered under the supervision of investigator site personnel.
5.4. Investigational Product Supplies
5.4.1. Dosage Form and Packaging
Investigational drug product, PF-06817024 Solution for Injection, 100 mg/mL, will be
supplied by Pfizer in a sterile, single-use glass vial with an aluminum flip off seal for both
intravenous and subcutaneous administration.
Placebo is supplied by Pfizer as a liquid solution in a glass vial with an aluminum flip off
seal for intravenous or subcutaneous administration.
5.4.2. Preparation and Dispensing
See the Investigational Product Manual (IP Manual) for instructions on how to prepare the
investigational product for administration.  Investigational product should be prepared and
dispensed by an appropriately qualified and experienced member of the study staff
(eg, physician, nurse, physician’s assistant, practitioner, or pharmacist) as allowed by local,
state, and institutional guidance.
PF-06817024 and placebo will be prepared by qualified unblinded site personnel according
to the IP Manual. The investigational product will be administered in a blinded fashion to
the subject.
5.4.3. Administration
PF-06817024 and placebo are administered intravenously and subcutaneously.
Following an overnight fast of least 10 hours (except for Part 3 as specified in the IP 
Manual), subjects will receive study treatment at approximately 08:00 hours (plus or minus
4 hours).  Study treatment will be administered as approximately 60-90 minute intravenous
infusion (Parts 1 and 2), approximately 90 minute intravenous infusion for Part 3, as 
specified in the IP manual, using a calibrated infusion pump for subjects receiving
IV administration (this may be modified up to 120 minutes by the Sponsor study team and 
the PI).  Study drug must not be administered as an IV push or bolus.  The start and stop time
of the infusion will be recorded.  Time 0 is the time when the study drug infusion begins.  
The infusion rate and amount of volume infused will be recorded.  For SC administration,
study treatment will be injected subcutaneously.  Each injection should occur at a different
site on the abdomen or thigh, approximately 1 cm apart. Administer study treatment
according to the IP Manual.
5.5. Injection/Infusion Discontinuation

If a subject experiences symptoms typical of an allergic reaction, the study drug
administration should be discontinued immediately and permanently.

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
If a subject experiences symptoms typical of infusion reactions (eg, lightheadedness,
nausea, chills, fever), the study drug infusion should be stopped.  At the discretion of
the investigator, the infusion can be restarted at a slower rate if symptoms are
resolved within 1 hour after the stop of infusion.  If symptoms return, then the study
drug administration should be discontinued immediately and permanently.

In the event that there is an infusion interruption, the entire duration of drug infusion,
from the initial start of infusion to the completion of infusion, should not exceed
3 hours.  The start and stop time of the infusion and the infusion rate and amount of
volume infused in the event of an interruption will be recorded. Subjects will receive
appropriate treatment at the discretion of the investigator.
5.6. Investigational Product Storage
The investigator or an approved representative (eg, pharmacist) will ensure that all
investigational products are stored in a secured area with controlled access under required
storage conditions and in accordance with applicable regulatory requirements.
Investigational product should be stored in its original container and in accordance with the
label.  Unused (unopened) investigational product or placebo vials stored at room 
temperature can be returned to 2C to 8C (36F to 46F) storage within 8 hours.  Unused 
vials must not be left at room temperature for more than 8 hours. 
From a microbiological point of view, the prepared products (active and placebo) must be 
used within 24 hours starting from the start of dose preparation.  If the prepared 
investigational product is left at room temperature for more than 8 hours, contact the Study 
Manager, or equivalent. See the IP Manual for additional information.
Storage conditions stated in the SRSD will be superseded by the storage conditions stated on
the product label.
Site systems must be capable of measuring and documenting (for example, via a log), at a
minimum, daily minimum and maximum temperatures for all site storage locations (as
applicable, including frozen, refrigerated, and/or room-temperature products).  This should
be captured from the time of investigational product receipt throughout the study.  Even for
continuous monitoring systems, a log or site procedure that ensures active daily evaluation
for excursions should be available.  The operation of the temperature-monitoring device and
storage unit (for example, refrigerator), as applicable, should be regularly inspected to ensure
it is maintained in working order.
Any excursions from the product-label storage conditions should be reported upon discovery.  
The site should actively pursue options for returning the product to the storage conditions as
described in the labeling, as soon as possible.  Deviations from the storage requirements,
including any actions taken, must be documented and reported to the sponsor.

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Once an excursion is identified, the investigational product must be quarantined and not used
until the sponsor provides documentation of permission to use the investigational product.  It
will not be considered a protocol deviation if the sponsor approves the use of the
investigational product after the temperature excursion.  Use of the investigational product
prior to sponsor approval will be considered a protocol deviation.  Specific details regarding
information the site should report for each excursion will be provided to the site.
5.7. Investigational Product Accountability
The investigative site must maintain adequate records documenting the receipt, use, loss, or
other disposition of the investigational product supplies.  All study drugs will be accounted
for using a drug accountability form/record.
5.7.1. Destruction of Investigational Product Supplies
The sponsor or designee will provide guidance on the destruction of unused investigational
product (eg, at the site).  If destruction is authorized to take place at the study site, the
investigator must ensure that the materials are destroyed in compliance with applicable
environmental regulations, institutional policy, and any special instructions provided by
Pfizer, and all destruction must be adequately documented.
5.8. Concomitant Treatment(s)
5.8.1. Part 1
Subjects will abstain from all concomitant treatments, except for the treatment of adverse
events, as described in the Exclusion Criteria sections of this protocol.  Limited use of
non-prescription medications that are not believed to affect subject safety or the overall
results of the study may be permitted on a case-by-case basis following approval by the
sponsor.
Females taking hormone replacement therapy may be eligible to participate in this study if
they are willing to discontinue therapy at least 28 days prior to the first dose of study
treatment and remain off hormonal therapy for the duration of the study.
5.8.2. Parts 1 and 2
All concomitant treatments taken during the study must be recorded with indication, daily
dose, and start and stop dates of administration.  All subjects will be questioned about
concomitant treatment at each clinic visit.
Treatments taken within 28 days before the first dose of study investigational product will be
documented as a prior treatment.  Treatments taken after the first dose of study
investigational product will be documented as concomitant treatments.

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5.8.3. Part 3
Subjects will be queried about concomitant medication (including topical medications and 
treatments, over-the-counter and prescription medications and treatments, and vaccinations) 
at each study visit. All concomitant treatments taken during the study must be recorded with
indication, daily dose, and start and stop dates of administration. Any new concomitant 
medications or dose changes to current concomitant medications should be evaluated for 
potential new or worsening adverse events.
Treatments taken within 42 days before the first dose of study investigational product will be
documented as a prior treatment.  Treatments taken after the first dose of study
investigational product will be documented as concomitant treatments.
The following concomitant therapies are permitted during the study:

Oral antihistamines (excluding H4 antagonists) for allergies. 

Stable dose of Leukotriene antagonists/modifiers.

Corticosteroid inhalers at allowed doses (see Exclusion criteria 28) and intranasal 
sprays are allowed for stable asthma and allergic rhinitis subjects respectively.

Non-medicated emollient and sunscreen are the only topical products permitted to be 
used on atopic dermatitis skin during the study. Subjects are recommended not to 
switch the emollient or sunscreen during the study.
A subject who is receiving a permitted concomitant medication for any reason must be on a 
locally-approved medication and dose for the treated indication, and this must be 
documented in the CRF.  Subjects are not allowed any other investigational drugs or 
treatments during the study. 
Subjects should refrain from starting new or changing doses of permitted prescription or 
non-prescription drugs, vitamins, and dietary supplements within 7 days or 5 half-lives 
(whichever is longer) prior to Day 1 and throughout the study, unless otherwise noted below.
Acetaminophen may be used intermittently (not to exceed 2.4 g/day).  Vitamin and mineral 
supplements of standard potency are allowed in amounts not known to be associated with 
adverse effects (such as hypervitaminosis). 
Subjects should report any changes to permitted medications during the study to the 
investigator as soon as they occur.  Medication changes must be documented in the subject’s 
record and CRF.
Unless a prohibited medication or treatment, subjects may be administered any other 
medications necessary for the treatment of concomitant medical disorders as deemed 
necessary by the treating physician.  Following Day 1, addition of concomitant medications 
or any change in the dosage should be limited to those considered medically essential.

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5.9. Prohibited Treatments and Medications during the Study
5.9.1. Part 2

Systemic corticosteroids.

Topical oxymetazoline (outside of study procedures: nasal endoscopy).

Monoclonal antibody (mAB) or immunosuppressive treatment.

Anti-immunoglobulin E (IgE) therapy (omalizumab).

Anti-IL-5 (eg, mepolizumab) therapy.

Leukotriene antagonists/modifiers unless patient is on a continuous treatment for at
least 28 days prior to Screening.
Patients with CRSwNP and asthma randomized into the study will be on standard of care 
treatment for their disease at time of randomization as prescribed by their physician that will 
not include prohibited concomitant medications as noted in Section 5.9.1. Subjects that are 
randomized into the study will continue on their baseline treatment regimen during the study.
Subjects randomized into the study will additionally have access to standard of care therapy, 
that may include the prohibited treatments and medications defined in Section 5.9.1, if such 
additional therapy is deemed necessary to treat their underlying disease.  A protocol 
deviation is to be completed for any patient that takes a prohibited treatment or medication 
during the study and the Sponsor is to be notified.  The patient may be replaced at the 
discretion of the principal investigator and/or the Sponsor.
5.9.2. Part 3
Subjects are required to discontinue and avoid using certain medications and treatments (per 
inclusion and exclusion criteria in Section 4.1.1.1 and 4.1.2.1).  Subjects should be instructed 
at each visit to contact the study site investigator promptly if there are any intended changes 
or additions to concomitant medications. These include:

Systemic and parenteral corticosteroids.

Leukotriene antagonists/modifiers unless patient is on a stable dose.

Anti-IL-33 targeted therapies.

Anti-IL-4 and/or IL-13 targeted therapies (eg, dupilumab, lebrkizumab, 
tralokinumab).

Mepolizumab, reslizumab.

Benralizumab.

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
Any cell-depleting agents including but not limited to rituximab.

Any JAK inhibitors.

Other biologics.

Investigational drugs.

Live or attenuated vaccines.

Oral immune suppressants (eg, cyclosporine A [CsA], azathioprine, MTX, Celcept, 
mycophenolate-mofetil, IFN-).

Oral or topical phosphodiesterase (PDE) 3 or PDE4 anatgonists (eg, apremilast, 
crisaborole).

Oral/topical histamine H4 antagonists.

Phototherapy (NB-UVB) or broad band phototherapy.

Regular use (more than 2 visits per week) of a tanning booth/parlor.

Topical treatments that could affect atopic dermatitis (eg, corticosteroids, calcineurin 
inhibitors, tars, antibiotic creams, topical antihistamines).

An inhaled dose of greater than 1000 g fluticasone, or an equivalent inhaled 
corticosteroid, per day.

Herbal medications with known anti-inflammatory effects or otherwise taken for AD.
A protocol deviation is to be completed for any subject that takes a prohibited treatment or 
medication during the study and the sponsor is to be notified.  The subject may be replaced at 
the discretion of the sponsor if prohibited treatments have been taken prior to Week 16.
All medications and treatments that could affect atopic dermatitis must be discontinued 
except permitted concomitant therapies (eg, oral antihistamines).  Due to the potential to 
affect atopic dermatitis with ultraviolet light exposure, subjects must also avoid prolonged 
exposure to the sun and avoid the use of tanning booths, sun lamps or other ultraviolet light 
sources during the study. 
For the purposes of this protocol, dietary supplements are defined as vitamins, minerals, 
purified food substances, and herbals with pharmaceutical properties.  Vitamins, minerals 
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Herbals supplements are only allowed on a case by case basis; please contact the Pfizer staff.  
Herbal medications with presumed anti-inflammatory properties or known beneficial effects 
for AD, or that are known to have an effect on drug metabolism (eg St. John’s Wort) must be 
discontinued at least 1 week or 5 half-lives (whichever is longer) before the first dose of 
investigational product. 
Restrictions on certain vaccinations are described in Section 5.9.2.2.
5.9.2.1. Rescue Medications
Subjects randomized into the study are allowed to take other treatments for their disease as 
prescribed by the investigator provided they are not included among the prohibited 
concomitant medications (noted in Section 5.9.2) and the concomitant drugs and doses are 
maintained unchanged throughout the first 16 weeks of the study. Although no specific 
rescue treatment is recommended, subjects randomized into the study may have access to 
standard of care therapy, that may include prohibited treatments and medications defined in 
Section 5.9.2, if deemed necessary by the investigator to treat their underlying disease. 
 
 
5.9.2.2. Vaccinations
Vaccination with live virus, attenuated live virus, or any live viral components is prohibited 
within 42 days of Day 1 dosing during the study, and for 6 weeks after the last dose of 
investigational product.  Similarly, current routine household contact with individuals who 
have been vaccinated with live vaccine components should be avoided during treatment and 
for 6 weeks following completion of treatment. 
Such vaccines include: FluMist® (intranasal influenza vaccine), attenuated rotavirus vaccine, 
varicella (chickenpox) vaccine, attenuated typhoid fever vaccine, oral polio vaccine, MMR 
(measles, mumps, rubella) vaccine and vaccinia (smallpox) vaccine.  Following vaccination 
with live component vaccines, the virus may be shed in bodily fluids, including stool, and 
there is a potential risk that the virus may be transmitted.
6. STUDY PROCEDURES
6.1. Part 1/Part 2
6.1.1. Screening
In Part 1 and Part 2, subjects will be screened within 28 days prior to administration of the
study treatment to confirm that they meet the subject selection criteria for the study.  The
investigator (or an appropriate delegate at the investigator site) will obtain informed consent
from each subject in accordance with the procedures described in the Subject Information
and Consent section.  If the time between Screening and dosing exceeds 28 days as a result of
unexpected delays (eg, delayed drug shipment), then subjects do not require re-screening if
the Day 0 laboratory results meet the eligibility criteria.
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In Part 1 only, a subject who qualified for this protocol (or who was excluded from 
Cohort 1-4 for IgE or Phadiatop results but otherwise qualified for this protocol) but did not
enroll from an earlier cohort may be used in a subsequent cohort without re-screening
provided the Day 0 laboratory results meet the eligibility criteria for this study. A subject 
who qualified for this protocol, completed Day 0 procedures and assessments, and was not 
dosed as one of the first two subjects in a cohort may be dosed after the study required 
minimum 24 hour pause (see Section 3.1) without repeating Day 0 procedures and 
assessments as long as no more than 48 hours separate Day 0 and Day 1.
The following procedures will be completed for both Part 1 and Part 2:
•
Obtain written informed consent.
•
Review Inclusion and Exclusion criteria.
•
Collect demography.
•
Collect height and weight.
•
Obtain medical history including:
•
History of illegal drug, alcohol and tobacco use.
•
Complete medication history of all prescription or nonprescription drugs, and
dietary and herbal supplements taken within 28 days prior to the planned first
dose.
•
Obtain supine blood pressure (BP), pulse rate (PR) and oral temperature.
•
Conduct full physical examination.
Note: A full physical examination may be done at screening or may be deferred to
Day 0 at the discretion of the principal investigator (PI).
•
Collect single 12-lead electrocardiogram (ECG).
•
Chest X-ray.
Note: Chest X-ray results within 3 months of the screening visit otherwise a chest
x-ray must be performed and results obtained prior to randomization.
•
Collect blood and urine specimens for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
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•
Serum FSH concentration for any female who has been amenorrheic for at least
12 consecutive months.
•
HIV, HBsAg, HBcAb, HCVAb (HBsAb test if screening results for HBsAg are 
negative and HBcAb are positive starting for Part 1 (Cohort 5 and later) and 
Part 2-see Section 4.1.2) tests.
•
QuantiFERON – Tuberculosis (TB) Gold Test.
•
Part 1 only: Phadiatop test (historical positive test result with appropriate 
documentation is acceptable Cohorts 1-4 only). Starting with Cohort 5 and later, 
Phadiatop is to be collected prior to dosing.
•
Serum IgE or test results within 6 months of screening visit (Part 1 Cohorts 1-4 
only).
 
•
Pregnancy test for female subjects of childbearing potential who have a 
documented bilateral tubal ligation or bilateral salpingectomy (Part 2 only).
•
Urine Drug Test and Alcohol Breath Test. 
Note: Subjects may undergo a urine drug test at the discretion of the investigator
at any time during the study.  An alcohol breath test is not mandatory but may be
given at Screening or any other time during the study at the discretion of the
investigator.
•
Spirometry: results acceptable within 3 months of screening visit otherwise a 
spirometry must be performed and results obtained prior to randomization (Part 2 
subjects with a history of asthma only).
•
Obtain information regarding the use of prior treatment and the occurrence of adverse
events.
•
Contraception Check.
•
Nasal Endoscopy and NPS (Part 2 only).
Note: The screening nasal endoscopy including NPS is to be completed after all other 
screening criteria have been verified. If a subject is eligible for the study, they will undergo 
nasal endoscopy including assessment of NPS, 
 
, ideally on Day 0. However, the baseline NPS 
 may be 
determined up to 5 days prior to Day 0. Thus, if a subject is screened and found eligible for 
the study based on NPS no more than 5 days prior to Day 0, the NPS from screening may be 
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used as the Day 0 NPS. 
 
 
To prepare for study participation, subjects will be instructed on the use of the Lifestyle
Guidelines and Concomitant Treatment(s) sections of the protocol.
6.1.2. Study Period
In Part 1 and Part 2, for the study period described below, when multiple procedures are
scheduled at the same time point(s) relative to dosing, the following chronology of events
should be adhered to, where possible:
•
ECGs: obtain prior to vital signs and as close as possible to scheduled time, but prior
to blood specimen collection.
•
Blood pressure/pulse rate: obtain as close as possible to scheduled time, but prior to
blood specimen collection.
•
Pharmacokinetic blood specimens: obtain at scheduled time.
•
Other procedures: obtain all other procedures as close as possible to the scheduled
time, but may be obtained before or after blood specimen collection.
When an intravenous catheter is utilized for blood sample collections, pre-dose ECGs and
vital signs (pulse rate [PR], BP, RR and Oral Temperature) assessments may be collected
prior to IV insertion of the catheter or at least 2 hours after IV insertion of the catheter.
6.1.2.1. Part 1 and Part 2: Day 0
Part 1 and Part 2: Subjects will be admitted to the Clinical Research Unit on Day 0. Part 2 
only: Day 0 may be an outpatient visit (at the discretion of the investigator). If Day 0 is an 
outpatient visit, the subject should be carefully instructed about fasting, avoidance of 
dietary/alcohol indiscretions, and avoidance of strenuous exercise. Additional baseline safety 
laboratory samples will need to be collected at Day 1 (-2 hours to -5 minutes).  The following
procedures will be completed following admission to the CRU:
•
Review Inclusion and Exclusion criteria (updated since screening).
•
Review changes in the subject’s medical history since screening, including history of
illegal drug, alcohol and tobacco use (updated since screening).
•
Conduct full physical examination, if deferred from the screening visit.  If a full
physical examination was conducted at screening, perform a limited physical
examination at Day 0.
•
Collect weight.
•
Obtain oral temperature.
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•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).  The results must have no clinically
significant findings, as judged by the investigator, in order for a subject to be
dosed on Day 1.
•
Pregnancy test for female subjects of childbearing potential who have a
documented bilateral tubal ligation or bilateral salpingectomy (Part 2 only).
•
Urine Drug Test and Alcohol Breath Test at the discretion of the investigator.
Note: Subjects may undergo a urine drug test at the discretion of the investigator
at any time during the study.  An alcohol breath test is not mandatory but may be
given at Screening or any other time during the study at the discretion of the
investigator.
If a subject is eligible for the study, they will undergo nasal endoscopy including assessment 
of NPS, 
 to assess the 
, ideally on Day 0.  However, the 
baseline NPS 
 may be determined up to 5 days prior to Day 0.
Thus, if a subject is screened and found eligible for the study based on NPS no more than 
5 days prior to Day 0, the NPS from screening may be used as the Day 0 NPS.
 
 
.
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•
Contraception Check.
•
Obtain information regarding the use of prior treatment and the occurrence of adverse 
events.
Subjects will begin fasting at least 10 hours prior to the collection of the pre-dose PK sample
on Day 1.
6.1.2.2. Part 1 and Part 2: Day 1
Prior to dosing, the following procedures will be completed:
•
Initiate continuous cardiac monitoring at least 2 hours prior to dosing.  This
continuous cardiac monitoring may also be performed any time after admission, but
prior to dosing.
Note: To establish a baseline, telemetry should be recorded for at least 2 hours before
dosing.  This may be done 2-hours immediately prior to dosing or at some 2-hour
continuous interval in the 24 hours prior to dosing, as long as the recording is
performed when the subject is awake.  Continuous cardiac monitoring will be
conducted approximately -5 minutes pre-dose through the 8 hour post-dose period.
•
Obtain supine blood pressure (BP), pulse rate (PR), respiratory rate (RR) and & oral
temperature. Pre-dose vitals may be collected prior to IV insertion of the catheter or
at least 2 hours after IV insertion of the catheter.
•
Collect triplicate 12-lead ECG measurements (Part 1 only.)
Note: ECGs will be collected in triplicate at approximately 2-4 minutes.
•
Collect single 12-lead ECG measurements (Part 2 only).
•
Pre-dose ECGs may be collected prior to IV insertion of the catheter or at least
2 hours after IV insertion of the catheter.
•
Insert IV catheter for blood collection.
Note: Site may insert IV catheter for blood sample collection up to 24 hours prior to
study drug administration.  IV catheter should be inserted in the extremity contra
lateral to that into which test article will be administered.  Heparin is not to be
utilized.
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•
Collect blood samples for the following:
•
Pharmacokinetic analysis (following at least a 10-hour fast).
•
Immunogenicity (ADA, NAb) blood sampling.
•
Obtain information regarding the use of prior treatment and the occurrence of adverse
events.
•
After all pre-dose procedures have been completed, insert IV catheter for study drug
infusion (IV cohorts only) and administer the study treatment (see STUDY
TREATMENTS and Administration Sections).
After dosing, the following procedures will be completed at the time(s) indicated in the SoA:
Note: The 1 hour post-dose procedures are to be implemented for all cohorts (IV and 
subcutaneous [SC]) as close to 1 hour as possible.  For the IV Cohorts, procedures are to 
occur after investigational product infusion is completed (see Dosage and Administration 
Instructions (DAI).  ECG and vital sign procedures may be collected up to 10 minutes prior 
to investigational product infusion completion. If any intravenous infusion time exceeds 
100 minutes, the post-dose time points for Day 1 (through 24 hours) will shift out relative to 
the end of infusion. 
•
Maintain continuous cardiac monitoring for 8 hours (or longer if considered clinically
necessary by the investigator) following dose administration.
•
Vital Signs (supine BP, PR, RR and oral temperature).
•
Collect triplicate 12-lead ECG measurements (Part 1 only).
Note: ECGs will be collected in triplicate at approximately 2-4 minutes.
•
Collect single 12-lead ECG measurements (Part 2 only).
•
Collect blood samples for the following:
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•
Pharmacokinetic analysis.
•
Assess infusion/injection site reaction.
Note: Subjects will be continuously monitored for infusion site reactions (for IV
administration) from start of drug administration until the end of infusion.  Injection 
site reactions (for SC administrations) should be monitored continuously for the first 
30 minutes and then at time points indicated in the SoA. 
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
•
Obtain information regarding the use of concomitant treatment.
6.1.2.3. Part 1 and Part 2: Days 2, 3 and 4
The following procedures will be completed as indicated in the SoA. Day 2 will occur for
Part 1 and Part 2, Days 3 and 4 for Part 1 only.
•
Conduct limited physical examination (Part 2 only).
•
Collect weight (Part 2 only).
•
Vital Signs (supine BP, PR, RR and oral temperature).
•
Collect triplicate 12-lead ECG measurements (Part 1 only).
Note: ECGs will be collected in triplicate at approximately 2-4 minutes.
•
Collect single 12-lead ECG measurements (Part 2 only). 
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Pharmacokinetic analysis.
•
Pregnancy test for female subjects of childbearing potential who have a 
documented bilateral tubal ligation or bilateral salpingectomy (Part 2 only).
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•
Assess infusion/injection site reaction.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
•
Obtain information regarding the use of concomitant treatment.
•
Contraception check (Part 2 only).
•
Discharge from Clinical Research Unit confinement (Part 2 only).
If a subject has any clinically significant, study-related abnormalities at the conclusion of a
scheduled inpatient portion of the study, the Pfizer medical monitor (or designated
representative) should be notified and the subject may be asked to remain in the Clinical
Research Unit until such abnormalities are deemed not clinically significant, or it is safe for
outpatient follow-up.  If the subject is unable or unwilling to remain in the Clinical Research
Unit and/or when outpatient follow-up is deemed appropriate, the Pfizer medical monitor (or
designated representative) should be so notified, and the investigator should make every
effort to arrange follow-up evaluations at appropriate intervals to document the course of the
abnormalities.
6.1.2.4. Part 1 and Part 2: Day 5
The following procedures will be completed:
•
Conduct limited physical examination.
•
Collect weight.
•
Vital Signs (supine BP, PR, RR and oral temperature).
•
Collect triplicate 12-lead ECG measurements (Part 1 only).
Note: ECGs will be collected in triplicate at approximately 2-4 minutes.
•
Collect single 12-lead ECG measurements (Part 2 only).
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Pharmacokinetic analysis.
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•
Pregnancy test for female subjects of childbearing potential who have a
documented bilateral tubal ligation or bilateral salpingectomy (Part 2 only).
•
Assess infusion/injection site reaction.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
•
Obtain information regarding the use of concomitant treatment.
•
Contraception check.
•
Discharge from Clinical Research Unit confinement (Part 1 only).
If a subject has any clinically significant, study-related abnormalities at the conclusion of a
scheduled inpatient portion of the study, the Pfizer medical monitor (or designated
representative) should be notified and the subject may be asked to remain in the Clinical
Research Unit until such abnormalities are deemed not clinically significant, or it is safe for
outpatient follow-up.  If the subject is unable or unwilling to remain in the Clinical Research
Unit and/or when outpatient follow-up is deemed appropriate, the Pfizer medical monitor (or
designated representative) should be so notified, and the investigator should make every
effort to arrange follow-up evaluations at appropriate intervals to document the course of the
abnormalities.
6.1.2.5. Part 1 and Part 2: Days 8 and 15
Part 1 and Part 2: Subjects will return to the Clinical Research Unit on Days 8 and 15
following the IV infusion/SC injection for outpatient visits.  The visit window noted in the
SoA is to be followed for all visits, which is relative to Day 1 dose administration.  At this
visit, the following procedures will be completed as indicated in the SoA.
•
Conduct limited physical examination.
•
Collect weight.
•
Vital Signs (supine BP, PR, RR and oral temperature).
•
Collect blood and urine samples for the following:
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•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Pharmacokinetic analysis.
•
Immunogenicity (ADA, NAb) blood sampling (Day 15 only).
•
Pregnancy test for female subjects of childbearing potential who have a
documented bilateral tubal ligation or bilateral salpingectomy (Part 2 only).
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
•
Contraception check.
•
Obtain information regarding the use of concomitant treatment and the occurrence of
adverse events.
6.1.2.6. Part 1 SAD and Part 2 Days 32 through Day 211
Part 1: Subjects who do not roll over into the multiple dose component of the study will
return to the Clinical Research Unit on Days 32, 46, 61, 91, 121, 151, 181, and 211.
Part 2: Patients will return on Days 32, 61, 91, 121, 181, and 211 following the IV infusion
for outpatient visits.
The visit window noted in the SoA is to be followed for all visits, which is relative to Day 1
dose administration.  At these visits, the following procedures will be completed as indicated
in the SoA.
•
Conduct limited physical examination, except at final study visit when a full physical
examination is required.
Note: A full physical examination may also be performed at the discretion of the
investigator at a follow-up visit if there is a new or open AE.
•
Collect weight.
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•
Vital Signs (supine BP, PR, RR and oral temperature).
•
Collect single 12-lead ECG measurement (except Day 46 for Part 1).
 
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry and
Urinalysis (following at least a 4-hour fast).
•
Pharmacokinetic analysis.
•
Immunogenicity (ADA, NAb) blood sampling.
•
Pregnancy test for female subjects of childbearing potential who have a
documented bilateral tubal ligation or bilateral salpingectomy (Part 2 only).
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
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•
Contraception check.
•
Obtain information regarding the use of concomitant treatment.
Part 1: SAD Cohorts 1, 2 and 6 will be discharged from the study at approximately Day 211.
SAD Cohorts 3-5 will also be discharged from the study at approximately Day 211 if NOT
rolled over into multiple dose component of study.
Part 2: Cohorts 8 and 9 will be discharged from the study at approximately Day 211.
6.1.2.7. Part 1: Multiple Dose Cohorts Day 31  
Subjects will be admitted to the Clinical Research Unit on approximately Day 31. If subjects 
are not admitted into the clinic for the second dose by Day 35 (Day 32 +3 days), subjects 
should follow SoA Table B Day 32 follow-up visit; if subjects are not admitted into the clinic 
for the second dose by Day 51 (Day 46+5 days), subjects should follow SoA Table B Day 32 
and Day 46 follow-up visits; if subjects are not admitted into the clinic for the second dose 
by Day 66 (Day 61+5 days), subjects should follow SoA Table B Day 32, Day 46, and 
Day 61 follow-up visits. SoA Table C visits would then shift out accordingly (by days of 
delay for each cohort/subject affected) ensuring 7 months of follow-up after the second dose.
If a subject cannot receive a second dose within the allotted time due to unexpected 
circumstances (eg, scheduling), they should follow SoA Table B through the end of the 
study. The following procedures will be completed following admission to the CRU.
•
Conduct limited physical examination.
Note: A full physical examination may also be performed at the discretion of the
investigator at a follow-up visit if there is a new or open AE.
•
Collect weight.
•
Vital Signs (supine BP, PR, RR and oral temperature).
•
Urine Drug Test and Alcohol Breath Test at the discretion of the investigator.
•
Collect blood and urine specimens for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Contraception check.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
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•
Obtain information regarding the use of concomitant treatment.
Subjects will begin fasting at least 10 hours prior to dosing on Day 32.
6.1.2.8. Part 1: Multiple Dose Cohorts Day 32
Prior to dosing, the following procedures will be completed:
•
Initiate continuous cardiac monitoring at least 2 hours prior to dosing.  This
continuous cardiac monitoring may also be performed any time after admission, but
prior to dosing.
Note: Telemetry may be collected after study team and investigator review safety data
required prior to initiating multiple dosing per protocol Section 3.1.
•
Obtain supine blood pressure (BP), pulse rate (PR), respiratory rate (RR) and & oral
temperature.  Pre-dose vitals may be collected prior to IV insertion of the catheter or
at least 2 hours after IV insertion of the catheter.
Note: Vital signs include BP, PR, RR, and oral temperature.  RR is to be collected at
Day 32 prior to dosing (up to 2 hours prior), daily during confinement, and at all
follow-up visits.
•
Collect triplicate 12-lead ECG measurements.  Pre-dose ECGs may be collected prior
to IV insertion of the catheter or at least 2 hours after IV insertion of the catheter.
Note: ECGs will be collected in triplicate approximately 2-4 minutes apart.
•
Insert IV catheter for blood collection.
Note: Site may insert IV catheter for blood sample collection up to 24 hours prior to
study drug administration.  IV catheter should be inserted in the extremity contra
lateral to that into which test article will be administered.  Heparin is not to be
utilized.
•
Collect blood samples for the following:
•
Pharmacokinetic analysis (following at least a 10 hour fast).
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•
Immunogenicity (ADA, NAb) blood sampling.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
•
Obtain information regarding the use of concomitant treatment.
•
After all pre-dose procedures have been completed, insert IV catheter for study drug 
infusion (IV cohorts only) and administer the study treatment (see STUDY
TREATMENTS and Administration Sections).
After dosing, the following procedures will be completed at the time(s) indicated in the SoA:
Note: The 1 hour post-dose procedures are to be implemented for all cohorts (IV and 
subcutaneous [SC]) as close to 1 hour as possible.  For the IV Cohorts, procedures are to 
occur after investigational product infusion is completed (see Dosage and Administration 
Instructions (DAI). ECG and vital sign procedures may be collected up to 10 minutes prior 
to investigational product infusion completion. If any intravenous infusion time exceeds 
100 minutes, the post-dose time points for Day 32 (through 24 hours) will shift out relative to 
the end of infusion.
•
Maintain continuous cardiac monitoring for 8 hours (or longer if considered clinically
necessary by the investigator) following dose administration.
•
Vital Signs (supine BP, PR, RR and oral temperature).
•
Obtain triplicate 12-lead ECG measurements.
•
Collect blood samples for the following:
•
Pharmacokinetic analysis.
•
Assess infusion/injection site reaction.
Note: Subjects will be continuously monitored for infusion site reactions (for IV 
administration) from start of drug administration until the end of infusion.  Injection 
site reactions (for SC administrations) should be monitored continuously for the first 
30 minutes and then at time points indicated in the SoA.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
•
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6.1.2.9. Part 1: Multiple Dose Cohorts Days 33 and 34
The following procedures will be completed:
•
Conduct limited physical examination (Day 34 only).
Note: A Full physical examinations is required at final study visit. A limited physical
examination will be completed at all other times specified in the SoA. A full physical
examination may also be performed at the discretion of the investigator at a follow-up 
visit if there is a new or open AE.
•
Collect weight (Day 34 only).
•
Vital Signs (supine BP, PR, RR and oral temperature).
•
Obtain single 12-lead ECG measurements.
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Pharmacokinetic analysis.
•
Obtain information regarding the use of concomitant treatment and the occurrence of
adverse events.
•
Assess infusion/injection site reaction.
•
Discharge from Clinical Research Unit confinement (Day 34).
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6.1.2.10. Part 1 Multiple Dose Cohorts Days 46 through Day 241
Subjects will return to the Clinical Research Unit on Days 46, 61, 91, 121, 151, 181, 211 and
241 following the IV infusion/SC injection for outpatient visits.  The visit window noted in
the SoA is to be followed for all visits, which is relative to the day of administration for the
second dose (a minimum of 4 weeks after the first dose).  At these visits, the following
procedures will be completed as indicated in the SoA.
•
Conduct limited physical examination.
Note: Full physical examination is required at the final study visit. A limited physical
examination will be completed at all other times specified in the SoA. A full physical
examination may also be performed at the discretion of the investigator at a follow-up 
visit if there is a new or open AE.
•
Collect weight.
•
Obtain single 12-lead ECG measurement at all visits except Day 46.
•
Vital Signs (supine BP, PR, RR and oral temperature).
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Pharmacokinetic analysis.
•
Immunogenicity (ADA, NAb) blood sampling.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
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•
Contraception check.
•
Obtain information regarding the use of concomitant treatment.
•
Cohorts 3-5 and 7 if rolled into the multiple dose component of the study /Cohorts
10-12 (if implemented) discharge from the study at approximately Day 241.
6.1.2.11. Extended Follow-up (Part 1 and Part 2)
Subjects having an unresolved adverse event that is possibly related to an ADA immune 
response will be asked to return for extended follow-up visit(s) at up to 3 month intervals 
beyond the last follow-up visit for up to 12 months after last drug administration or until the 
adverse event or its sequelae resolve or stabilize at a level acceptable to the investigator and 
Sponsor concurs with the investigator’s assessment. If the emerging data project that 
half-life is longer than 41 days, subjects will be asked to return for extended follow-up 
visit(s) at up to 3 month intervals beyond the last follow-up visit to cover approximately
≥5 times the observed half-life
 
 
 
OR of sufficient duration to have projected exposures decrease below ADA drug tolerance 
levels
 
At these visits, the following procedures will be completed as 
indicated in the SoA.
•
Conduct limited physical examination. 
Note: Full physical examination is required at the final study visit. A limited physical 
examination will be completed at all other times specified in the SoA. A full physical
examination may also be performed at the discretion of the investigator at a follow-up 
visit if there is a new or open AE.
•
Collect blood samples for the following:
•
Pharmacokinetic analysis.
•
Immunogenicity (ADA, NAb) blood sampling.
 
•
Safety labs for extended follow-up visits may be done at the discretion of the PI 
for cohorts currently in the study.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
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
Contraception check.

Obtain information regarding the use of concomitant treatment. 
6.1.2.12. Subject Withdrawal (Part 1 and Part 2)
Withdrawal of consent: Subjects who request to discontinue receipt of study treatment will
remain in the study and must continue to be followed for protocol-specified follow-up 
procedures.  The only exception to this is when a subject specifically withdraws consent for
any further contact with him or her or persons previously authorized by the subject to provide
this information.  Subjects should notify the investigator in writing of the decision to
withdraw consent from future follow-up, whenever possible.  The withdrawal of consent
should be explained in detail in the medical records by the investigator, as to whether the
withdrawal is only from further receipt of investigational product or also from study
procedures and/or post-treatment study follow-up, and entered on the appropriate CRF/Data 
Clarification Form (DCF) page.  In the event that vital status (whether the subject is alive or
dead) is being measured, publicly available information should be used to determine vital
status only as appropriately directed in accordance with local law.
Lost to follow-up: All reasonable efforts must be made to locate subjects to determine and
report their ongoing status.  This includes follow-up with persons authorized by the subject
as noted above.  All attempts should be documented in the subject’s medical records.  If it is
determined that the subject has died, the site will use permissible local methods to obtain the
date and cause of death.  If the investigator’s use of a third-party representative to assist in
the follow-up portion of the study has been included in the subject’s informed consent, then
the investigator may use a sponsor-retained third-party representative to assist site staff with
obtaining the subject’s contact information or other public vital status data necessary to
complete the follow-up portion of the study.  The site staff and representative will consult
publicly available sources, such as public health registries and databases, in order to obtain
updated contact information.  If, after all attempts, the subject remains lost to follow-up, then
the last-known-alive date as determined by the investigator should be reported and
documented in the subject’s medical records.
Subjects may withdraw from the study at any time at their own request, or they may be
withdrawn at any time at the discretion of the investigator or sponsor for safety or, behavioral
reasons, or the inability of the subject to comply with the protocol-required schedule of study
visits or procedures at a given study site.  The early termination visit only applies to subjects
who are randomized and then are prematurely withdrawn from the study.
If a subject does not return for a scheduled visit, every effort should be made to contact the
subject.  The Investigator or site staff should attempt to contact the subject twice.  After two
attempts, CRU staff may send a registered letter.  If no response is received from the subject,
the subject will be considered lost to follow-up.  All attempts to contact the subject and
information received during contact attempts must be documented in the subject’s medical
record.  In any circumstance, every effort should be made to document subject outcome, if
possible.  The investigator should inquire about the reason for withdrawal, request that the

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subject return for a final visit, if applicable, and follow-up with the subject regarding any
unresolved adverse events (AEs).
It may be appropriate for the subject to return to the clinic for final safety assessments to be
scheduled as early as practically feasible following the decision to withdraw from the study.  
Subjects should be questioned regarding their reason for withdrawal.  At the early withdrawal
visit, every effort must be made to complete the following assessments:
•
Full physical examination, if there is a new or open AE or clinically significant
abnormal physical finding from the last visit.
•
Vital Signs (supine BP, PR, RR and oral temperature).
•
Collect triplicate 12-lead ECG measurements (Part 1 only).
•
Collect single 12-lead ECG measurements (Part 2 only). 
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Pregnancy test for female subjects of childbearing potential who have a
documented bilateral tubal ligation or bilateral salpingectomy (Part 2 only).
•
Pharmacokinetic analysis.
•
Immunogenicity (ADA, NAb) blood sampling.
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Lack of completion of all or any of the early termination procedures will not be viewed as
protocol deviations so long as the subject’s safety was preserved.
If the subject withdraws from the study and also withdraws consent for disclosure of future
information, no further evaluations should be performed and no additional data should be
collected.  The sponsor may retain and continue to use any data collected before such
withdrawal of consent.
Subjects who withdraw from the study may be replaced at the discretion of the investigator
upon consultation with the sponsor (provided the nature of the safety event does not preclude
dose escalation and exposure stopping limits are observed).
6.2. Part 3 
For the study period described below, when multiple procedures are scheduled at the same 
time point(s) relative to dosing, the following chronology of events should be adhered to
 
•
Pre-dose vitals may be collected prior to IV insertion of the catheter or at least 
2 hours after IV insertion of the catheter and must be done as close to the dosing time 
as possible. Pre-dose vitals will be recorded as 0 hr measurements.
•
Pre-dose ECGs may be collected prior to IV insertion of the catheter or at least 
2 hours after IV insertion of the catheter and must be done as close to the dosing time 
as possible. Pre-dose ECG measurements will be recorded as 0 hr measurements.
•
Pre-dose activities on Day 1, Day 29, Day 57, Day 85 may be performed, at the 
discretion of the investigator, on the day preceding each dose (ie, on Day 0, Day 28, 
Day 56, Day 84) as inpatient in clinical site or outpatient. Inpatient subjects will be 
admitted to the clinic day prior to the dosing visits (Day 1, Day 29, Day 57, Day 85). 
The pre-dose activities include medical history, atopic dermatitis history including 
atopic disease history, history of illegal drug, alcohol and tobacco use, 
inclusion/exclusion criteria, physical examination, weight, urine drug test and alcohol 
breath test, pregnancy test, safety laboratory (hematology, chemistry, urinanalysis), 
 
 
 clinical assessments (Fitzpatrick skin type,
 
Pre-dose safety labs for the purposes of Inclusion/Exclusion criteria 
may be done 2 days prior to dosing on Day 1. Pre-dose samples collected for PK, 
Immunogenicity, 
 and 
 will be recorded as 0 hr 
samples. 
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•
 
 
 
•
Physical examination must be conducted prior to dosing on the dosing visit days.
•
For dosing visits performed as outpatient visits, the subject should be carefully 
instructed about fasting, avoidance of dietary/alcohol indiscretions, and avoidance of 
strenuous exercise. See Section 4.3.2. 
6.2.1. Screening
Subjects will be screened within 42 days prior to administration of the study treatment to
confirm that they meet the subject selection criteria for the study.  The investigator (or an
appropriate delegate at the investigator site) will obtain informed consent from each subject
in accordance with the procedures described in the Subject Information and Consent section.  
If the time between Screening and dosing exceeds 42 days as a result of unexpected delays 
(eg, delayed drug shipment), then subjects do not require re-screening if the Day 0 laboratory 
results meet the eligibility criteria.
Screening laboratory tests with abnormal results may be repeated once to confirm abnormal 
results; the last value will be used to determine eligibility.  If results return to normal within 
the 6-week screening period, the subject may enter the study.  Sites will be permitted to 
re-screen subjects (with a new screening number) who initially do not meet eligibility criteria 
once.  If some screening laboratory tests are missing, but the subject has met all the 
remaining Inclusion/Exclusion criteria, then these missing laboratory tests must be performed 
at an unplanned visit during the screening window. Alternatively, the tests may be 
performed prior to randomization or on Day 1 provided the results are available to determine 
eligibility prior to randomization. 
The following procedures will be completed as applicable and stipulated in the Schedule of 
Activities:
•
Obtain written informed consent.
•
Perform AD assessments : EASI, IGA.
•
Columbia Suicide Severity Rating Scale (C-SSRS) assessment.
•
Review Inclusion and Exclusion criteria.
•
Collect demography.
•
Obtain medical history including:
•
History of illegal drug, alcohol, and tobacco use.
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
Complete medication history of all prescription or nonprescription drugs, and
dietary and herbal supplements taken within 28 days prior to the planned first
dose.

AD history, including other atopic diseases.

Collect height and weight.

Obtain supine blood pressure (BP), pulse rate (PR) and temperature.

Conduct full physical examination.
Note: A full physical examination may be done at screening or may be deferred to
Day 1 at the discretion of the principal investigator (PI).

Collect single 12-lead electrocardiogram (ECG).

Chest X-ray.
Note: Chest X-ray results within 3 months of the screening visit otherwise a chest
x-ray (standard posterior-anterior and lateral views) must be performed and results
obtained prior to randomization.

Collect blood and urine specimens for the following:

Safety laboratory tests: includes Hematology, Chemistry, and Urinalysis
(following at least a 4-hour fast).

Serum FSH concentration for any female who has been amenorrheic for at least
12 consecutive months.

HIV, HBsAg, HBcAb, HCVAb (HBsAb test if screening results for HBsAg are 
negative and HBcAb are positive).

QuantiFERON – Tuberculosis (TB) Gold Test.

Pregnancy test for female subjects of childbearing potential.

Urine Drug Test and Alcohol Breath Test. 
Note: Subjects may undergo a urine drug test at the discretion of the investigator
at any time during the study.  An alcohol breath test is not mandatory but may be
given at Screening or any other time during the study at the discretion of the
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•
Spirometry: results acceptable within 3 months of screening visit otherwise a 
spirometry must be performed and results obtained prior to randomization (for 
subjects with a history of asthma, only).
•
Obtain information regarding the occurrence of adverse events.
•
Contraception Check.
To prepare for study participation, subjects will be instructed on the use of the
Lifestyle Guidelines (Section 4.3.2) and Concomitant Treatment(s) sections of the
protocol.
6.2.2. Part 3 (Day 1, Day 29, Day 57, Day 85) – Dosing visits
Prior to dosing, the following procedures will be completed: 
 
 
 
 
 
•
Review Inclusion and Exclusion criteria (updated since screening) (Day 1 only).
•
Review changes in the subject’s medical history since screening, including history of 
illegal drug, alcohol and tobacco use, atopic dermatitis history including other atopic 
diseases, medication history (updated since screening) (Day 1 only).
•
Obtain supine blood pressure (BP), pulse rate (PR), respiratory rate (RR) and & 
temperature.  Pre-dose vitals may be collected prior to IV insertion of the catheter or 
at least 2 hours after IV insertion of the catheter.
•
Perform a limited physical examination. Full physical examination maybe done on 
Day 1 if a limited physical examination is performed at screening.
•
Pre-dose single ECGs may be collected prior to IV insertion of the catheter or at least 
2 hours after IV insertion of the catheter and must be done on the day of dosing.
•
Weight.
•
Insert IV catheter for blood collection.
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Note: Site may insert IV catheter for blood sample collection up to 24 hours prior to 
study drug administration only for subject who will be admitted to the clinical site a 
day prior to dosing. IV catheter for blood sampling may be replaced with 
phlebotomy procedures at the investigator’s discretion. All blood samples for 
laboratory testing must be drawn from the extremity contralateral to that into which 
test article will be administered. If an indwelling catheter is used, heparin is not to be 
utilized to maintain patency. 
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory tests include Hematology, Chemistry, 
and Urinalysis (following at least a 4-hour fast).  The available results must have 
no clinically significant findings, as judged by the investigator, in order for a 
subject to be dosed. Results for most laboratory tests collected on the visit day 
likely will not be available on the same day for review before dosing, in which 
case the available laboratory tests will only consist of those from the previous 
visit. All such laboratory results must be reviewed prior to dosing. Pregnancy 
testing MUST have been performed within the permitted window and the result 
MUST be negative for female subjects of childbearing potential prior to dosing.
•
Urine Drug Test and Alcohol Breath Test (Day 1). 
•
Pharmacokinetic analysis.
 
 
•
Immunogenicity (ADA, NAb) blood sampling.
•
Pregnancy test for female subjects of childbearing potential.
•
Urine Drug Test and Alcohol Breath Test (Day 1 only).
•
Perform AD assessments: Fitzpatrick skin type assessment (Day 1 only),
 
.
•
Obtain information regarding the use of prior treatment and the occurrence of adverse 
events.
•
Contraception check.
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•
After all pre-dose procedures have been completed, insert IV catheter for study drug 
infusion (IV cohorts only) and administer the study treatment (see STUDY
TREATMENTS and Administration Sections).
After dosing, the following procedures will be completed at the time(s) indicated in the SoA:
Note: The 1.5 hour post-dose procedures are to be implemented for as close to 1.5 hour as 
possible.  Procedures are to occur after investigational product infusion is completed (see 
Dosage and Administration Instructions (DAI).  PK draws need to be done after the 
completion of infusion.  ECG and vital sign procedures may be collected up to 10 minutes 
prior to investigational product infusion completion.  If any intravenous infusion time 
exceeds 1.5 hrs, the post-dose time points for Day 1 will shift out relative to the end of 
infusion. The actual times need to be documented in the CRF. In the event the infusion is 
interrupted and restarted, the start and end times for the infusion prior and post interruption 
must be collected.
•
Vital Signs (supine BP, PR, RR and temperature).
•
Collect single 12-lead ECG measurements.
•
Collect blood samples for the following:
•
Pharmacokinetic analysis (1.5 and 4 hours).
•
Remove IV catheter(s).
•
Assess infusion/injection site reaction. 
Note: Subjects will be frequently monitored for infusion site reactions from start of 
drug administration until the end of infusion. 
•
Assess symptoms by spontaneous reporting of adverse events and by asking the 
subjects to respond to a non-leading question such as “How do you feel?”
•
Obtain information regarding the use of concomitant treatment. 
•
Discharge from the clinical site if the subject has been admitted.
6.2.3. Part 3 (Day 8) 
 
•
Conduct limited physical examination. 
•
Vital Signs (supine BP, PR and temperature).
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•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Pharmacokinetic analysis.
•
Immunogenicity (ADA, NAb) blood sampling.
•
Pregnancy test for female subjects of childbearing potential.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the 
subjects to respond to a non-leading question such as “How do you feel?”
•
Contraception check.
•
Obtain information regarding the use of concomitant treatment and the occurrence of 
adverse events.
6.2.4. Part 3 (Day 113, Day 141, Day 169, Day 253, Day 337)
 
•
Collect weight.
•
Obtain supine blood pressure (BP), pulse rate (PR) and temperature.
•
Conduct limited physical examination. 
Note: Full physical examinations are required at the final study visit and early 
termination visit.  A limited physical examination will be completed at all other times 
specified in the SoA.  A full physical examination may also be performed at the 
discretion of the investigator at a follow-up visit if there is a new or open AE.
•
Collect single 12-lead ECG measurements (Day 113, Day 141 and Day 253).
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast) (Day 113, Day 253 and Day 337). 
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•
Pharmacokinetic analysis (Day 113, Day 253 and Day 337).
 
 
 
•
Immunogenicity (ADA, NAb) blood sampling (Day 113, Day 253 and Day 337).
•
Pregnancy test for female subjects of childbearing potential.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the 
subjects to respond to a non-leading question such as “How do you feel?” 
•
Contraception check.
•
Obtain information regarding the use of concomitant treatment. 
6.2.5. Extended Follow-up 
At these visits, the following procedures will be completed as indicated in the SoA.
 
•
Obtain supine blood pressure (BP), pulse rate (PR) and temperature.
•
Collect weight.
•
Conduct limited physical examination. 
Note: Full physical examination is required at the final study visit. A limited physical 
examination will be completed at all other times specified in the SoA. A full physical 
examination may also be performed at the discretion of the investigator at a follow-up 
visit if there is a new or open AE.
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Pharmacokinetic analysis.
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•
Immunogenicity (ADA, NAb) blood sampling.
•
Pregnancy test for female subjects of childbearing potential.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
•
Contraception check.
•
Obtain information regarding the use of concomitant treatment.
6.2.6. Subject Withdrawal
Withdrawal of consent: Subjects who request to discontinue receipt of study treatment will 
remain in the study and must continue to be followed for protocol-specified follow-up 
procedures.  The only exception to this is when a subject specifically withdraws consent for 
any further contact with him or her or persons previously authorized by the subject to provide 
this information.  Subjects should notify the investigator in writing of the decision to 
withdraw consent from future follow-up, whenever possible.  The withdrawal of consent 
should be explained in detail in the medical records by the investigator, as to whether the 
withdrawal is only from further receipt of investigational product or also from study 
procedures and/or post-treatment study follow-up, and entered on the appropriate CRF/DCF
page.  In the event that vital status (whether the subject is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law.
Lost to follow-up: All reasonable efforts must be made to locate subjects to determine and 
report their ongoing status.  This includes follow-up with persons authorized by the subject 
as noted above.  All attempts should be documented in the subject’s medical records.  If it is 
determined that the subject has died, the site will use permissible local methods to obtain the 
date and cause of death.  If the investigator’s use of a third-party representative to assist in 
the follow-up portion of the study has been included in the subject’s informed consent, then 
the investigator may use a sponsor-retained third-party representative to assist site staff with 
obtaining the subject’s contact information or other public vital status data necessary to 
complete the follow-up portion of the study.  The site staff and representative will consult 
publicly available sources, such as public health registries and databases, in order to obtain 
updated contact information.  If, after all attempts, the subject remains lost to follow-up, then 
the last-known-alive date as determined by the investigator should be reported and 
documented in the subject’s medical records.
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Subjects may withdraw from the study at any time at their own request, or they may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety or, behavioral
reasons, or the inability of the subject to comply with the protocol-required schedule of study 
visits or procedures at a given study site.  The early termination visit only applies to subjects 
who are randomized and then are prematurely withdrawn from the study.
If a subject does not return for a scheduled visit, every effort should be made to contact the
subject.  The Investigator or site staff should attempt to contact the subject twice.  After two
attempts, CRU staff may send a registered letter.  If no response is received from the subject,
the subject will be considered lost to follow-up.  All attempts to contact the subject and
information received during contact attempts must be documented in the subject’s medical
record.  In any circumstance, every effort should be made to document subject outcome, if
possible.  The investigator should inquire about the reason for withdrawal, request that the
subject return for a final visit, if applicable, and follow-up with the subject regarding any
unresolved adverse events (AEs).
It may be appropriate for the subject to return to the clinic for final safety assessments to be 
scheduled as early as practically feasible following the decision to withdraw from the study.  
Subjects should be questioned regarding their reason for withdrawal.  At the early withdrawal 
visit, every effort must be made to complete the following assessments:
 
•
Full physical examination, if there is a new or open AE or clinically significant 
abnormal physical finding from the last visit.
•
Vital Signs (supine BP, PR and temperature) at the discretion of the Investigator.
•
Collect weight.
•
Collect single 12-lead ECG measurements (if subject withdraws before Day 113).
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Pregnancy test for female subjects of childbearing potential.
•
Pharmacokinetic analysis.
 
•
Immunogenicity (ADA, NAb) blood sampling.
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•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
•
Contraception check.
•
Obtain information regarding the use of concomitant treatment.
Lack of completion of all or any of the early termination procedures will not be viewed as 
protocol deviations so long as the subject’s safety was preserved.
If the subject withdraws from the study and also withdraws consent for disclosure of future 
information, no further evaluations should be performed and no additional data should be 
collected.  The sponsor may retain and continue to use any data collected before such 
withdrawal of consent.
Subjects who withdraw from the study may be replaced at the discretion of the investigator 
upon consultation with the sponsor (provided the nature of the safety event does not preclude 
dose escalation and exposure stopping limits are observed).
6.2.7. End of Study (EOS)
Subjects will be discharged either by phone or may need to return for one final visit. See 
Section 1.3.1.3 for criteria for discharge.
The following procedures will be done at the discharge visit if required.
 
•
Full physical examination.
•
Vital Signs (supine BP, PR and temperature) at the discretion of the Investigator.
•
Collect blood and urine samples for the following:
•
Safety laboratory tests: Safety laboratory includes Hematology, Chemistry, and 
Urinalysis (following at least a 4-hour fast).
•
Pregnancy test for female subjects of childbearing potential.
•
Pharmacokinetic analysis.
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•
Immunogenicity (ADA, NAb) blood sampling.
•
Assess symptoms by spontaneous reporting of adverse events and by asking the
subjects to respond to a non-leading question such as “How do you feel?”
•
Contraception check.
•
Obtain information regarding the use of concomitant treatment.
•
Discharge from study.
7. ASSESSMENTS
Every effort should be made to ensure that protocol-required tests and procedures are
completed as described.  However, it is anticipated that from time to time there may be
circumstances, outside the control of the investigator that may make it unfeasible to perform
the test.  In these cases, the investigator must take all steps necessary to ensure the safety and
well-being of the subject.  When a protocol-required test cannot be performed, the
investigator will document the reason for the missed test and any corrective and preventative
actions that he or she has taken to ensure that required processes are adhered to as soon as
possible.  The study team must be informed of these incidents in a timely manner.
7.1. Part 1 and 2
7.1.1. Safety
7.1.1.1. Laboratory Tests
The following safety laboratory tests will be performed at times defined in the STUDY
PROCEDURES section of this protocol.  Additional laboratory results may be reported on
these samples as a result of the method of analysis or the type of analyzer used by the clinical
laboratory; or as derived from calculated values.  These additional tests would not require
additional collection of blood.  Unscheduled clinical labs may be obtained at any time during
the study to assess any perceived safety concerns.
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Table 4.
Laboratory Tests
Hematology
Chemistry
Urinalysis
Other
Hemoglobin
Hematocrit
RBC count
MCV
MCH
MCHC
Platelet count
WBC count
Total neutrophils
(Abs)
Eosinophils (Abs)
Monocytes (Abs)
Basophils (Abs)
Lymphocytes (Abs)
BUN/urea and Creatinine
Glucose (fasting)
Calcium
Sodium
Potassium
Chloride
Total CO2 (Bicarbonate)
AST, ALT
Total Bilirubin
Alkaline phosphatase
Uric acid
Albumin
Total protein
pH
Glucose (qual)
Protein (qual)
Blood (qual)
Ketones
Nitrites
Leukocyte esterase
Urobilinogen
Urine bilirubin
Microscopya
FSHb
HCGc
Urine drug screeningd
HIV, HBsAg, HBcAb,
and HCVAbe
HBsAbf
Phadiatope
QuantiFERON-TB Gold
Teste
Additional Tests (Needed
for Hy’s law)
AST, ALT (repeat)
Total bilirubin (repeat)
Albumin (repeat)
Alkaline phosphatase
(repeat)
Direct bilirubin
Indirect bilirubin
Creatine kinase
GGT
PT/INR
a.
Only if urine dipstick is positive for blood, protein, nitrites or leukocyte esterase.
b. At Screening only, in females who are amenorrheic for at least 12 consecutive months.
c.
HCG (human chorionic gonadotropin) for female subjects of childbearing potential who have a
documented bilateral tubal ligation or bilateral salpingectomy (Part 2 only)
d. At Screening, Day 0, and Day 31 (screening and Day 0 only for SAD cohorts).
e.
At screening only. Phadiatop collection for Part 1 only; starting with Cohort 5 and later, Phadiatop is to 
be collected prior to dosing.
f.
HBsAb test if screening results for HBsAg are negative and HBcAb are positive (for Part 1 (Cohort 5 
and later) and Part 2.

Part 1: Minimum requirement for drug screening includes: cocaine,
tetrahydrocannabinol (THC), opiates/opioids, benzodiazepines and amphetamines.

Part 2: Minimum requirement for drug screening includes: cocaine, opiates/opioids,
benzodiazepines and amphetamines.

Subjects may undergo random urine drug screening at the discretion of the 
investigator.  Drug screening conducted prior to dosing must be negative for subjects
to receive study medication.

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7.1.1.2. Pregnancy Testing (Part 2)
For female subjects of childbearing potential, a serum or urine pregnancy test, with 
sensitivity of at least 25 mIU/mL, will be performed at Screening, admission or Day 1 of all 
study periods, and follow-up visits.  Results will be obtained prior to dosing during each 
period. 
A negative pregnancy result is required before the subject may receive the investigational 
product.  Pregnancy tests will also be done whenever one menstrual cycle is missed during 
the active treatment period (or when potential pregnancy is otherwise suspected), Pregnancy 
tests may also be repeated as per request of institutional review boards (IRBs)/ ethics 
committees (ECs) or if required by local regulations.
In the case of a positive confirmed pregnancy, the subject will be withdrawn from 
administration of investigational product but may remain in the study. 
7.1.1.3. Physical Examinations
Physical examinations may be conducted by a physician, trained physician's assistant, or
nurse practitioner as acceptable according to local regulation.  A full physical examination
will include head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes,
gastrointestinal, musculoskeletal, and neurological systems.  The limited or abbreviated
physical examination will be focused on general appearance including skin (specific attention 
to infusion and injection site reactions), the respiratory, gastrointestinal, and cardiovascular
systems, as well as towards subject reported symptoms.
For measuring weight, a scale with appropriate range and resolution is used and must be
placed on a stable, flat surface.  Subjects must remove shoes, bulky layers of clothing, and
jackets so that only light clothing remains.  They must also remove the contents of their
pockets and remain still during measurement of weight.
7.1.1.4. Blood Pressure and Pulse Rate
Blood pressure and pulse rate will be measured at times specified in STUDY
PROCEDURES section of this protocol.  Additional collection times, or changes to
collection times of blood pressure and pulse rate will be permitted, as necessary, to ensure
appropriate collection of safety data.
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Supine blood pressure will be measured with the subject’s arm supported at the level of the
heart and recorded to the nearest mm Hg after approximately 5 minutes of rest.  The same
arm (preferably the dominant arm) will be used throughout the study.  Blood pressure should
not be taken from the arm with an intravenous infusion.  Subjects should be instructed not to
speak during measurements.
The same properly sized and calibrated blood pressure cuff will be used to measure blood
pressure each time.  The use of an automated device for measuring BP and pulse rate is
acceptable, although, when done manually, pulse rate will be measured in the brachial/radial
artery for at least 30 seconds.  When the timing of these measurements coincides with a
blood collection, blood pressure and pulse rate should be obtained prior to the nominal time
of the blood collection.
7.1.1.5. Respiratory Rate
Respiratory rate will be measured after approximately 5 minutes rest in supine position by
observing and counting the respirations of the subject for 30 seconds and multiplied by 2.  
When blood pressure is to be taken at the same time, respiration measurement will be done
during the 5 minutes of rest and before blood pressure measurement.
7.1.1.6. Temperature
Temperature will be measured orally.  No eating, drinking or smoking is allowed for
15 minutes prior to the measurement.
7.1.1.7. Electrocardiogram
Electrocardiograms (ECGs) should be collected at times specified in the STUDY
PROCEDURES section of this protocol.
All scheduled ECGs should be performed after the subject has rested quietly for at least
10 minutes in a supine position.
Triplicate 12-lead ECGs will be obtained approximately 2-4 minutes apart during clinical
confinement at times specified in the SoA. Single ECGs will be collected at all other
designated visits per SoA. The average of the triplicate ECG measurements collected
pre-dose on Day 1 will serve as each subject’s baseline QTc value.  When the timing of these
measurements coincides with a blood collection, the ECG should be obtained prior to the
nominal time of the blood collection, blood pressure and pulse rate.
To ensure safety of the subjects, a qualified individual at the investigator site will make
comparisons to baseline measurements. If the QTc interval for single ECG collections is
increased by 45 msec from the baseline, or an absolute QTc value is 500 msec for any
scheduled ECG, then 2 additional ECGs will be collected, approximately 2-4 minutes apart,
to confirm the original measurement.  If either of the QTc values from these repeated ECGs
remains above the threshold value (45 msec from the baseline; or is 500 msec), then a
single ECG must be repeated at least hourly until QTc values from 2 successive ECGs fall
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For triplicate ECGs, if the average of QTc values from the triplicate measurements remains
above the threshold value (45 msec from the baseline; or is 500 msec), then a single ECG
must be repeated at least hourly until QTc values from 2 successive ECGs fall below the
threshold value that triggered the repeat measurement.
If QTc values remain 500 msec (or 45 msec from the baseline) for greater than 4 hours (or
sooner at the discretion of the investigator); or QTc intervals get progressively longer, the
subject should undergo continuous ECG monitoring.  A cardiologist should be consulted if
QTc intervals do not return to less than 500 msec (or to <45 msec above the baseline) after
8 hours of monitoring (or sooner at the discretion of the investigator).
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead
placement as contributing to the ECG abnormality.  It is important that leads are placed in the
same positions each time in order to achieve precise ECG recordings.  If a machine-read QTc
value is prolonged, as defined above, repeat measurements may not be necessary if a
qualified physician’s interpretation determines that the QTc values are in the acceptable
range.
7.1.1.8. Continuous Cardiac Monitoring by Telemetry
All abnormal rhythms will be recorded and reviewed by the study physician for the presence
of rhythms of potential clinical concern.  The time, duration, and description of the clinically
significant event will be recorded in the CRF/DCT. In addition, a printed record of the
tracing(s) of the clinically significant rhythm(s) will be made and retained with other source
documents.
Telemetry should be collected using a centralized system that also allows for the storage and
advanced analysis of all recorded data in order to preserve important events for future
evaluations.  Holter monitoring should not be used in parallel with continuous telemetry,
unless it is the only means of data storage available at the study site, or verifiable arrhythmia
quantification is required.  To establish a baseline, telemetry should be recorded for at least
2 hours before dosing.  This may be done immediately prior to dosing or at some 2-hour
continuous interval in the 24 hours prior to dosing, as long as the recording is performed
when the subject is awake.  Telemetry may be stopped within a reasonably short period of
time prior to dosing, in order to avoid interference with study operations conducted
immediately before dosing.  However, it is expected that the telemetry leads will be in place
and the system connected prior to dosing.
7.1.1.9. Infusion and Injection Site Reaction Assessment
Subjects will be monitored for signs of any infusion site reactions including but not limited to
erythema, swelling, bruising, pain or pruritus as times specified in the SoA.
Subject enrolled in to the SC single dose cohort will be monitored for signs of injection site
reactions included but not limited to erythema, swelling, skin ulceration, pain or pruritus.
Any signs or symptoms related to either an infusion or injection site reaction should be
treated according to the Investigator’s standard of care and reported as adverse events.

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7.1.2. Pharmacokinetic, Immunogenicity,
Samples
All samples will be collected according to the times outlined in the SoA. Details regarding
the collection, processing, storage and shipping of the blood samples will be provided to the
investigator site prior to initiation of the study. Samples will be analyzed using a validated
analytical method in compliance with Pfizer standard operating procedures for PK, 
Anti-PF-06817024 ADA and NAb analysis; 
.
The samples must be processed and shipped as indicated to maintain sample integrity.  Any
deviations from the processing steps (eg, sample collection and processing steps, interim
storage or shipping conditions), including any actions taken, must be documented and
reported to the sponsor.  On a case-by-case basis, the sponsor may make a determination as
to whether sample integrity has been compromised.  Any deviation from the specified sample
handling procedure resulted in compromised sample integrity, will be considered a protocol
deviation.
As part of understanding the pharmacokinetics,
and immunogenicity of
the study drug, samples may be used for further characterization and/or evaluation of the
bioanalytical method.
PK and immunogenicity samples from subjects receiving placebo will not be routinely 
analyzed.  
 
7.1.3. Pharmacokinetics (PK) for PF-06817024
Blood samples (4 mL) to provide a minimum of 1.5 mL serum for pharmacokinetic analysis
will be collected into appropriately labeled tubes containing no anticoagulant or gel serum
separator at times specified in the SoA section of the protocol.
The actual times for sample collection may change but the number of samples will remain
the same.  All efforts will be made to obtain the pharmacokinetic samples at the exact
nominal time relative to dosing.  However, samples obtained within 10% of the nominal time
(eg, within 6 minutes of a 60 minute sample) from dosing will not be captured as a protocol
deviation, as long as the exact time of the sample collection is noted on the source document
and data collection tool (eg, CRF/DCT).
7.1.4. Immunogenicity
Blood samples (4 mL) to provide a minimum of 1.5 mL serum for ADA and NAb analysis
will be collected into appropriately labeled tubes containing no anticoagulant or gel serum 
separator. 
Samples will be analyzed using a validated analytical method in compliance with 
Pfizer/vendor standard operating procedures (SOPs). Samples determined to be positive for 
ADA may be further characterized for NAb.
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7.1.9. Blood Volume
The total blood sampling volume for individual subjects in Part 1 of this study is
approximately 690.5 mL for those in the SAD portion (from Screening through Day 211) and
approximately 835 mL for those in the multiple dose component (from Screening through
Day 241).  The total blood sampling volume for individual subjects in Part 2 of this study
(from Screening through Day 211) is approximately 624 mL. Table 5 and Table 6 reflect
approximate sample volumes needed for each measured endpoint.  The actual collection
times of blood sampling may change, but the total blood volume collected will not increase.  
Additional blood samples may be taken for safety assessments at times specified by Pfizer,
provided the total volume taken during the study does not exceed 550 mL during any period
of 30 consecutive days.
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Table 5.
Blood Volume for Part 1
Sample Type
Sample
Volume
(mL)
Number of Sampling Times
Total Volume
(mL)
(SAD/multiple 
dose)
Screening
Study Period
(SAD/multiple 
dose)
Follow-Up Visits
(SAD/multiple 
dose)
Safety Labs
(including
hematology,
serology, chemistry
and FSH)
7
1
5/10
10/8
112/133
QuantiFERON TB
Gold Test
3
1
0
0
3
Phadiatop
4
1
0
0
4
PK
4
0
10/20
10/8
80/112
 
Immunogenicity
(ADA, NAb)
4
0
1/3
9/8
40/44
TOTAL
690.5/835
SAD = Single ascending dose; TB = Tuberculosis. 
This total volume does not include discarded blood from pre-draws used to remove fluid from flushed
catheters or extended follow-up visits, if applicable. Each extended follow-up visit will increase the Total 
Blood Volume by 11 mL per visit.
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Table 6.
Blood Volume for Part 2
Sample Type
Sample
Volume (mL)
Number of Sampling Times
Total Volume
(mL)
Screening
Study Period
Follow-Up
Visits
Safety Labs (including
hematology, serology,
chemistry, HCG and FSH)
7
1
2
9
84
QuantiFERON TB Gold Test
3
1
0
0
3
PK
4
0
7
9
64
Immunogenicity (ADA,
NAb)
4
0
1
7
32
TOTAL
624
TB = Tuberculosis. 
This total volume does not include discarded blood from pre-draws used to remove fluid from flushed
catheters or extended follow-up visits, if applicable.  Each extended follow-up visit will increase the Total 
Blood Volume by 13 mL per visit.
7.1.9.1. Potential Cases of Acute Kidney Injury
Abnormal values in serum creatinine (SCr) concurrent with absence of increase in blood urea
nitrogen (BUN) that meet the criteria below, in the absence of other causes of kidney injury,
are considered potential cases of acute kidney injury and should be considered important
medical events.
An increase of ≥0.3 mg/dL (or ≥26.5 μmol/L) in serum creatinine relative to subjects’ own
baseline measurement should trigger another assessment of SCr as soon as practically
feasible, preferably within 48-hours from awareness
If the second assessment (after the 1st observations of ≥0.3 mg/dL (or ≥26.5 μmol/L) in
serum creatinine relative to subjects’ own baseline measurement) is ≥0.4 mg/dL (or
≥35.4 μmol/L), the subject should be discontinued from the study and adequate, immediate,
supportive measures taken to correct apparent acute kidney injury
Subjects should return to the investigational site and be evaluated as soon as possible,
preferably within 48-hours from awareness of the second assessment confirming abnormal
SCr result.  This evaluation should include laboratory tests, detailed history, and physical
assessment.  In addition to repeating SCr, laboratory tests should include: serum
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blood-urea-nitrogen, serum creatine kinase, serum electrolytes (including at a minimum
potassium, sodium, phosphate/phosphorus, calcium), in addition to urinary dipstick, urine
microscopic examination, and urinary indices.  All cases confirmed on repeat testing as
meeting the laboratory criteria for acute-kidney-injury, with no other cause(s) of laboratory
abnormalities identified should be considered as potential cases of drug-induced kidney
injury irrespective of availability of all the results of the investigations performed to
determine etiology of the abnormal SCr.  If ≥2 subjects in the same cohort are noted to have
2 consecutive SCr results of ≥0.3 mg/dL (or ≥26.5 μmol/L), an assessment of whether the
finding may be considered adverse drug reaction should be undertaken.
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
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7.1.16. Endoscopy (Part 2 only)
A nasal endoscopy is to be completed during the screening period per SoA Table D.  A
qualified ear, nose, and throat (ENT) physician is to complete the nasal endoscopy and
endoscopic nasal polyp score (NPS) to determine study eligibility.
7.1.16.1. Nasal Polyp Score (Part 2 only)
The NPS used to assess eligibility for inclusion in this study is a modified version of the 
staging system proposed by the Rhinosinusitis Initiative in 2006,44 as used in studies of nasal 
steroids,45 dupilumab,46 omalizumab,47 reslizumab,48 and mepolizumab49 in CRSwNP. The
NPS is to be completed and calculated by an ENT physician (see Appendix 3).
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7.2. Part 3
7.2.1. Safety
7.2.1.1. Laboratory Tests
The following safety laboratory tests will be performed at times defined in the STUDY
PROCEDURES section of this protocol.  Additional laboratory results may be reported on 
these samples as a result of the method of analysis or the type of analyzer used by the clinical 
laboratory; or as derived from calculated values.  These additional tests would not require 
additional collection of blood.  Unscheduled clinical labs may be obtained at any time during 
the study to assess any perceived safety concerns.  Abnormal safety labs maybe repeated at 
investigator’s discretion.  Safety labs maybe collected by standard phlebotomy or from the 
IV catheter.
Table 7.
Laboratory Tests
Hematology
Chemistry
Urinalysis
Other
Hemoglobin
Hematocrit
RBC count
MCV
MCH
MCHC
Platelet count
WBC count
Total neutrophils
(Abs)
Eosinophils (Abs)
Monocytes (Abs)
Basophils (Abs)
Lymphocytes (Abs)
BUN/urea and Creatinine
Glucose (fasting)
Calcium
Sodium
Potassium
Chloride
Total CO2 (Bicarbonate)
AST, ALT
Total Bilirubin
Alkaline phosphatase
Uric acid
Albumin
Total protein
pH
Glucose (qual)
Protein (qual)
Blood (qual)
Ketones
Nitrites
Leukocyte esterase
Urobilinogen
Urine bilirubin
Microscopya
FSHb,f
HCGc
Urine drug screeningf,g
HIV, HBsAg, HBcAb, 
and HCVAbe,f
HBsAbd
QuantiFERON-TB Gold 
Testf
Additional Tests (Needed
for Hy’s law)
AST, ALT (repeat)
Total bilirubin (repeat)
Albumin (repeat)
Alkaline phosphatase 
(repeat)
Direct bilirubin
Indirect bilirubin
Creatine kinase
GGT
PT/INR
a.
Only if urine dipstick is positive for blood, protein, nitrites or leukocyte esterase.
b. At Screening only, in females who are amenorrheic for at least 12 consecutive months. 
c.
Serum or Urine HCG (human chorionic gonadotropin) (sensitivity of 25 mIU/mL) for female subjects 
of childbearing potential.
d. HBsAb test if screening results for HBsAg are negative and HBcAb are positive.
e.
HCV RNA test will be done as a reflex for positive HCVAb test.
f.
At screening.
g. At Day 1.

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•
Minimum requirement for drug screening includes: cocaine, opiates/opioids,
benzodiazepines and amphetamines.
•
Subjects may undergo random urine drug screening at the discretion of the 
investigator.  Drug screening conducted prior to dosing must be negative for subjects
to receive study medication. If urine drug test result at baseline is not available, 
subject with a negative drug test result at screening may be dosed if the subject has no 
prior history of drug abuse.
•
Any remaining serum/plasma from samples collected for clinical safety labs at
baseline may be retained for at least 2 years from the time of collection or 1 year after 
the completion of the study (whichever comes first), after which they can be 
discarded. 
7.2.1.2. Pregnancy Testing
For female subjects of childbearing potential, a serum or urine pregnancy test with sensitivity 
of at least 25 mIU/mL, will be performed at Screening, all study periods (Week 0, Week 1, 
Week 4, Week 8, Week 12, Week 16), follow-up (Week 20, Week 24, Week 36, Week 48) 
and extended follow-up visits.  Results will be obtained prior to dosing during each period. 
A negative pregnancy result is required before the subject may receive the investigational 
product.  In addition, urine pregnancy tests must be done at home by female subjects of 
childbearing potential at the nominal visits corresponding to Week 28, Week 32, Week 40 
and Week 44 and every month between the scheduled extended visit follow-up visits. PI 
must be informed immediately if pregnancy test is positive and must see the PI for retesting.  
Pregnancy tests will also be done whenever one menstrual cycle is missed during the active 
treatment period (or when potential pregnancy is otherwise suspected). Pregnancy tests may 
also be repeated as per request of institutional review boards (IRBs)/ ethics committees (ECs) 
or if required by local regulations.
Pregnancy testing MUST have been performed within the permitted window and the result 
MUST be negative for female subjects of childbearing potential prior to dosing. Pregnancy 
test results will be documented in the CRF.
In the case of a positive confirmed pregnancy, the subject will be withdrawn from 
administration of investigational product but may remain in the study. 
7.2.1.3. Physical Examinations
Physical examinations may be conducted by a physician, trained physician's assistant, or 
nurse practitioner as acceptable according to local regulation.  A full physical examination 
will include head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, 
gastrointestinal, musculoskeletal, and neurological systems.  The limited or abbreviated 
physical examination will be focused on general appearance including skin (specific attention 
to infusion and injection site reactions), the respiratory, gastrointestinal, and cardiovascular 
systems, as well as towards subject reported symptoms.
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For measuring weight, a scale with appropriate range and resolution is used and must be
placed on a stable, flat surface.  Subjects must remove shoes, bulky layers of clothing, and
jackets so that only light clothing remains.  They must also remove the contents of their
pockets and remain still during measurement of weight.
7.2.1.4. Blood Pressure and Pulse Rate
Blood pressure and pulse rate will be measured at times specified in STUDY
PROCEDURES section of this protocol.  Additional collection times, or changes to
collection times of blood pressure and pulse rate will be permitted, as necessary, to ensure
appropriate collection of safety data.
Supine blood pressure will be measured with the subject’s arm supported at the level of the
heart and recorded to the nearest mm Hg after approximately 5 minutes of rest.  The same
arm (preferably the dominant arm) will be used throughout the study.  Blood pressure should
not be taken from the arm with an intravenous infusion.  Subjects should be instructed not to
speak during measurements.
The same properly sized and calibrated blood pressure cuff will be used to measure blood 
pressure each time.  The use of an automated device for measuring BP and pulse rate is 
acceptable, although, when done manually, pulse rate will be measured in the brachial/radial 
artery for at least 30 seconds.  When the timing of these measurements coincides with a 
blood collection, blood pressure and pulse rate should be obtained prior to the nominal time 
of the blood collection.
7.2.1.5. Respiratory Rate 
Respiratory rate will be measured after approximately 5 minutes rest in supine position by
observing and counting the respirations of the subject for 30 seconds and multiplied by 2.  
When blood pressure is to be taken at the same time, respiration measurement will be done 
during the 5 minutes of rest and before blood pressure measurement.  Post-dose Respiratory 
rate measurements to be done at Investigator’s discretion.
7.2.1.6. Temperature
Temperature will be measured by oral, tympanic, or temporal artery method, provided the 
same method is used consistently throughout the study.  No eating, drinking or smoking is 
allowed for 15 minutes prior to the measurement.
7.2.1.7. Electrocardiogram 
Electrocardiograms (ECGs) should be collected at times specified in the STUDY
PROCEDURES section of this protocol.
All scheduled ECGs should be performed after the subject has rested quietly for at least
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Single ECGs will be collected at all other designated visits per SoA. When the timing of
these measurements coincides with a blood collection, the ECG should be obtained prior to
the nominal time of the blood collection, blood pressure and pulse rate. 
To ensure safety of the subjects, a qualified individual at the investigator site will make 
comparisons to baseline measurements.  If the QTc interval for single ECG collections is 
increased by ≥45 msec from the baseline, or an absolute QTc value is ≥500 msec for any 
scheduled ECG, then 2 additional ECGs will be collected, approximately 2-4 minutes apart, 
to confirm the original measurement.  If either of the QTc values from these repeated ECGs 
remains above the threshold value (≥45 msec from the baseline; or is ≥500 msec), then a 
single ECG must be repeated at least hourly until QTc values from 2 successive ECGs fall 
below the threshold value that triggered the repeat measurement.
If QTc values remain ≥500 msec (or ≥45 msec from the baseline) for greater than 4 hours (or 
sooner at the discretion of the investigator); or QTc intervals get progressively longer, the 
subject should undergo continuous ECG monitoring.  A cardiologist should be consulted if 
QTc intervals do not return to less than 500 msec (or to <45 msec above the baseline) after 
8 hours of monitoring (or sooner at the discretion of the investigator).
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead 
placement as contributing to the ECG abnormality.  It is important that leads are placed in the 
same positions each time in order to achieve precise ECG recordings.  If a machine-read QTc 
value is prolonged, as defined above, repeat measurements may not be necessary if a 
qualified physician’s interpretation determines that the QTc values are in the acceptable 
range.
7.2.1.8. Infusion and Injection Site Reaction Assessment 
Subjects will be monitored for signs of any infusion site reactions including but not limited to
erythema, swelling, bruising, pain or pruritus as times specified in the SoA.
Any signs or symptoms related to either an infusion or injection site reaction should be
treated according to the Investigator’s standard of care and reported as adverse events.
7.2.2. Pharmacokinetic, Immunogenicity, 
 Samples 
All samples will be collected according to the times outlined in the SoA. Details regarding
the collection, processing, storage and shipping of the blood samples will be provided to the
investigator site prior to initiation of the study.  Samples will be analyzed using a validated
analytical method in compliance with Pfizer standard operating procedures for PK, 
Anti-PF-06817024 ADA and NAb analysis; 
 
The samples must be processed and shipped as indicated to maintain sample integrity.  Any
deviations from the processing steps (eg, sample collection and processing steps, interim
storage or shipping conditions), including any actions taken, must be documented and
reported to the sponsor.  On a case-by-case basis, the sponsor may make a determination as
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to whether sample integrity has been compromised.  Any deviation from the specified sample
handling procedure resulted in compromised sample integrity, will be considered a protocol
deviation.
As part of understanding the pharmacokinetics (PK), 
 and 
immunogenicity of the study drug, samples may be used for further characterization and/or 
evaluation of the bioanalytical methods.  
 
 
 
PK and immunogenicity samples from subjects receiving placebo will not be routinely 
analyzed. 
 
7.2.2.1. Pharmacokinetics (PK) for PF-06817024
Blood samples (4 mL) to provide a minimum of 1.5 mL serum for pharmacokinetic analysis
will be collected into appropriately labeled tubes containing no anticoagulant or gel serum 
separator at times specified in the SoA Table E of the protocol.
The actual times for sample collection may change but the number of samples will remain
the same.  All efforts will be made to obtain the pharmacokinetic samples at the exact
nominal time relative to dosing.  However, samples obtained within 10% of the nominal time
(eg, within 6 minutes of a 60 minute sample) from dosing will not be captured as a protocol
deviation, as long as the exact time of the sample collection is noted on the source document
and data collection tool (eg, CRF/DCT).
7.2.2.2. Immunogenicity
Blood samples (4 mL) to provide a minimum of 1.5 mL serum for ADA and NAb analysis
will be collected into appropriately labeled tubes containing no anticoagulant or gel serum 
separator. 
Samples will be analyzed using a validated analytical method in compliance with 
Pfizer/vendor standard operating procedures (SOPs).  Samples determined to be positive for 
ADA may be further characterized for NAb.
 
 
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7.2.5. Blood Volume
The total blood sampling volume for individual subjects in Part 3 of this study (from 
Screening through Day 337) is approximately 368 mL (Table 8). The actual collection times
of blood sampling may change, but the total blood volume collected will not increase.  
Additional blood samples may be taken for safety assessments at times specified by Pfizer,
provided the total volume taken during the study does not exceed 550 mL during any period 
of 30 consecutive days.
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Table 8.
Blood Volume for Part 3
Sample Type
Sample 
Volume (mL)
Number of Sampling Times
Total 
Volume 
(mL)
Screening
Study Period
(Day1/
Week 
0-Day 113/
Week 16)
Follow-Up Visits
(Day 141/
Week 20 –
Day 337/
Week 48)
Safety Labs (including 
hematology, serology, 
chemistry, HCG and FSH)
7
1
6
2
63
QuantiFERON TB Gold Test
3
1
0
0
3
PK
4
0
10
2
48
 
 
 
 
 
Immunogenicity (ADA, 
NAb)
4
0
6
2
32
 
TOTAL
368
ADA = antidrug antibody; 
 
 FSH = follicle-stimulating hormone; HCG = human chorionic gonadotropin; TB = Tuberculosis; 
 
 
 
 NAb = neutralizing antibody; PK = pharmacokinetic; 
This total volume does not include discarded blood from pre-draws used to remove fluid from flushed catheters 
or extended follow-up visits, if applicable.  Each extended follow-up visit will increase the Total Blood Volume 
by 44 mL per visit.
7.2.5.1. Potential Cases of Acute Kidney Injury
See Section 7.1.9.1.
7.2.6. Atopic Dermatitis History
Atopic Dermatitis Disease History includes AD diagnosis, AD history including atopic 
disease history, duration of AD, the use of topical treatments, systemic treatments and other 
treatments for AD. Inclusion/exclusion criteria assessment includes diagnosis of chronic AD 
(per Eichenfield revised criteria of Hannifin and Rajka-Appendix 16, EASI (includes BSA) –
Appendix 8 and IGA – Appendix 10) performed at the screening visit.
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7.2.7. Spirometry (subjects with a history of asthma only)
Spirometry is to be completed during the screening period per SoA Table E. Post screening 
spirometry may be performed at investigator discretion to assess potential changes in lung 
function. Spirometry will be performed using standardized equipment.  Spirometry will be 
performed in accordance with American Thoracic Society/European Respiratory Society 
(ATS/ERS) Task Force: standardization of lung function testing guidelines 2005.38  
Sufficient forced expiratory maneuvers (up to a maximum of 5) will be performed to produce 
at least 1 technically adequate tracing.  The forced expiratory volume in one second (FEV1) 
will be recorded as absolute volumes in liters and in terms of predicted values (Third 
National Health and Nutrition Examination Survey (NHANES III))39 according to age, 
height, race and gender.  The best (largest) FEV1 measurement from the technically adequate 
tracings collected will be used to determine eligibility for the study.
7.2.8. Physician Assessments 
7.2.8.1. Fitzpatrick Skin Type Assessment 
As part of baseline characteristics, a skin type assessment will be done at the Day 1 visit 
using the Fitzpatrick Skin Phototype assessment (Appendix 7).  This is used to classify a 
person’s skin type by their response to sun exposure (ie, burning or tanning).
7.2.8.2. Eczema Area and Severity Index (EASI)63
The EASI quantifies the severity of a subject’s atopic dermatitis based on both severity of 
lesion clinical signs and the percent of BSA affected.  EASI is a composite scoring by the 
atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, 
excoriation, and lichenification (each scored separately) for each of four body regions, with 
adjustment for the percent of BSA involved for each body region and for the proportion of 
the body region to the whole body. See Appendix 8.
 
 
7.2.8.4. Investigator Global Assessment (IGA)64
The clinical evaluator of atopic dermatitis will perform an assessment of the overall severity 
of atopic dermatitis and assign an IGA score and category as described in Appendix 10.  The 
assessment will be a static evaluation without regard to the score at a previous visit. 
7.2.8.5. Columbia Suicide Severity Rating Scale (C-SSRS)66
Columbia suicide severity rating scale is a validated tool to evaluate suicidal ideation and 
behavior (Appendix 15). 
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At Screening Visit, if there are “yes” answers on items 4, 5 in the past year or on any 
question in the suicidal behavior section of the C-SSRS in the past 6 months, the subject will 
not be included in the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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8. ADVERSE EVENT REPORTING
8.1. Adverse Events
All observed or volunteered AEs regardless of treatment group or suspected causal
relationship to the investigational product(s) will be reported as described in the following
sections.
For all AEs, the investigator must pursue and obtain information adequate both to determine
the outcome of the AE and to assess whether it meets the criteria for classification as a
serious adverse event (SAE) requiring immediate notification to Pfizer or its designated
representative.  For all AEs, sufficient information should be obtained by the investigator to
determine the causality of the AE.  The investigator is required to assess causality.  
Follow-up by the investigator may be required until the event or its sequelae resolve or
stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment.
As part of ongoing safety reviews conducted by the sponsor, any nonserious AE that is
determined by the sponsor to be serious will be reported by the Sponsor as a SAE.  To assist
in the determination of case seriousness, further information may be requested from the
investigator to provide clarity and understanding of the event in the context of the clinical
study.
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8.2. Reporting Period
For SAEs, the active reporting period to Pfizer or its designated representative begins from
the time that the subject provides informed consent, which is obtained prior to the subject’s
participation in the study, ie, prior to undergoing any study-related procedure and/or
receiving investigational product, through the end of the study.  SAEs occurring to a subject
after the active reporting period has ended should be reported to the sponsor if the
investigator becomes aware of them; at a minimum, all SAEs that the investigator believes
have at least a reasonable possibility of being related to investigational product are to be
reported to the Sponsor.
AEs (serious and nonserious) should be recorded on the CRF/DCT from the time the subject
has taken at least 1 dose of investigational product through the subject’s last visit.
8.3. Definition of an Adverse Event
An AE is any untoward medical occurrence in a clinical investigation subject administered a
product or medical device; the event need not necessarily have a causal relationship with the
treatment or usage.  Examples of AEs include but are not limited to:

Abnormal test findings.

Clinically significant symptoms and signs.

Changes in physical examination findings.

Hypersensitivity.

Progression/worsening of underlying disease.

Drug abuse.

Drug dependency.
Additionally, they may include the signs or symptoms resulting from:

Drug overdose.

Drug withdrawal.

Drug misuse.

Drug interactions.

Extravasation.

Exposure during pregnancy (EDP).

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
Exposure via breastfeeding.

Medication error.

Occupational exposure.
8.4. Medication Errors
Medication errors may result, in this study, from the administration or consumption of the
wrong product, to the wrong subject, at the wrong time or at the wrong dose strength.  Such
medication errors occurring to a study participant are to be captured on the medication error
CRF/DCT, which is a specific version of the AE page and on the SAE form when
appropriate.  In the event of medication dosing error, the sponsor should be notified
immediately.
Medication errors are reportable irrespective of the presence of an associated AE/SAE,
including:

Medication errors involving subject exposure to the investigational product.

Potential medication errors or uses outside of what is foreseen in the protocol that do
or do not involve the participating subject.
Whether or not the medication error is accompanied by an AE, as determined by the
investigator, the medication error is captured on the medication error version of the AE page
and, if applicable, any associated AE(s) are captured on an AE CRF/DCT page.
8.5. Abnormal Test Findings
The criteria for determining whether an abnormal objective test finding should be reported as
an AE are as follows:

Test result is associated with accompanying symptoms; and/or

Test result requires additional diagnostic testing or medical/surgical intervention;
and/or

Test result leads to a change in study dosing (outside of protocol-stipulated dose
adjustments) or discontinuation from the study, significant additional concomitant
drug treatment, or other therapy; and/or

Test result is considered to be an AE by the investigator or sponsor.
Merely repeating an abnormal test, in the absence of any of the above conditions, does not
constitute an AE.  Any abnormal test result that is determined to be an error does not require
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8.6. Serious Adverse Events
A serious adverse event is any untoward medical occurrence at any dose that:

Results in death.

Is life-threatening (immediate risk of death).

Requires inpatient hospitalization or prolongation of existing hospitalization.

Results in persistent or significant disability/incapacity (substantial disruption of the
ability to conduct normal life functions).

Results in congenital anomaly/birth defect.
Medical and scientific judgment is exercised in determining whether an event is an important
medical event.  An important medical event may not be immediately life-threatening and/or
result in death or hospitalization.  However, if it is determined that the event may jeopardize
the subject or may require intervention to prevent one of the other AE outcomes, the
important medical event should be reported as serious.
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 hospitalization;
or development of drug dependency or drug abuse.
8.6.1. Protocol-Specified Serious Adverse Events
There are no protocol-specified SAEs in this study.  All SAEs will be reported by the
investigator as described in previous sections and will be handled as SAEs in the safety
database (see the section on Serious Adverse Event Reporting Requirements).
8.6.2. Potential Cases of Drug-Induced Liver Injury
Abnormal values in aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)
levels concurrent with abnormal elevations in total bilirubin level that meet the criteria
outlined below in the absence of other causes of liver injury are considered potential cases of
drug-induced liver injury (potential Hy’s law cases) and should always be considered
important medical events.
The threshold of laboratory abnormalities for a potential case of drug-induced liver injury
depends on the subject’s individual baseline values and underlying conditions.  Subjects who
present with the following laboratory abnormalities should be evaluated further to
definitively determine the etiology of the abnormal laboratory values:

Subjects with AST or ALT and total bilirubin baseline values within the normal range
who subsequently present with AST or ALT values 3 times the upper limit of
normal (x ULN) concurrent with a total bilirubin value 2 x ULN with no evidence of
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
For subjects with preexisting ALT OR AST OR total bilirubin values above the
ULN, the following threshold values should be used in the definition mentioned
above:

For subjects with preexisting AST or ALT baseline values above the normal
range: AST or ALT values 2 times the baseline values and 3 x ULN, or
8 x ULN (whichever is smaller).
Concurrent with:

For subjects with preexisting values of total bilirubin above the normal range:
Total bilirubin level increased from baseline by an amount of at least 1 x ULN or
if the value reaches 3 x ULN (whichever is smaller).
The subject should return to the investigational site and be evaluated as soon as possible,
preferably within 48 hours from awareness of the abnormal results.  This evaluation should
include laboratory tests, detailed history and physical assessment.
In addition to repeating measurements of AST and ALT, laboratory tests should include
albumin, creatine kinase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl
transferase (GGT), prothrombin time (PT)/international normalized ratio (INR), and alkaline
phosphatase.  A detailed history, including relevant information, such as review of ethanol,
acetaminophen, recreational drug, and supplement consumption, family history, occupational
exposure, sexual history, travel history, history of contact with a jaundiced person, surgery,
blood transfusion, history of liver or allergic disease, and work exposure, should be collected.  
Further testing for acute hepatitis A, B, or C infection and liver imaging (eg, biliary tract)
may be warranted.  All cases confirmed on repeat testing as meeting the laboratory criteria
defined above, with no other cause for liver function test (LFT) abnormalities identified at
the time, should be considered potential Hy’s law cases irrespective of availability of all the
results of the investigations performed to determine etiology of the abnormal LFTs.  Such
potential Hy’s law cases should be reported as SAEs.
8.7. Hospitalization
Hospitalization is defined as any initial admission (even less than 24 hours) in a hospital or
equivalent healthcare facility or any prolongation of an existing admission.  Admission also
includes transfer within the hospital to an acute/intensive care unit (eg, from the psychiatric
wing to a medical floor, medical floor to a coronary care unit, or neurological floor to a
tuberculosis unit).  An emergency room visit does not necessarily constitute a hospitalization;
however, the event leading to the emergency room visit should be assessed for medical
importance.
Hospitalization does not include the following:

Rehabilitation facilities.

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
Respite care (eg, caregiver relief).

Skilled nursing facilities.

Nursing homes.

Same-day surgeries (as outpatient/same-day/ambulatory procedures).
Hospitalization or prolongation of hospitalization in the absence of a precipitating, clinical
AE is not in itself an SAE.  Examples include:

Admission for treatment of a preexisting condition not associated with the
development of a new AE or with a worsening of the preexisting condition (eg, for
workup of persistent pre-treatment laboratory abnormality).

Social admission (eg, subject has no place to sleep).

Administrative admission (eg, for yearly physical examination).

Protocol-specified admission during a study (eg, for a procedure required by the study
protocol).

Optional admission not associated with a precipitating clinical AE (eg, for elective
cosmetic surgery).

Hospitalization for observation without a medical AE.

Preplanned treatments or surgical procedures.  These should be noted in the baseline
documentation for the entire protocol and/or for the individual subject.
Diagnostic and therapeutic noninvasive and invasive procedures, such as surgery, should not
be reported as AEs.  However, the medical condition for which the procedure was performed
should be reported if it meets the definition of an AE.  For example, an acute appendicitis
that begins during the AE reporting period should be reported as the AE, and the resulting
appendectomy should be recorded as treatment of the AE.
8.8. Severity Assessment
If required on the AE CRFs/DCTs, the investigator will use the adjectives MILD,
MODERATE, or SEVERE to describe the maximum intensity of the AE.  For purposes
of consistency, these intensity grades are defined as follows:
MILD
Does not interfere with subject's usual function.
MODERATE
Interferes to some extent with subject's usual function.
SEVERE
Interferes significantly with subject's usual function.

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Note the distinction between the severity and the seriousness of an AE.  A severe event is not
necessarily an SAE.  For example, a headache may be severe (interferes significantly with
the subject's usual function) but would not be classified as serious unless it met one of the
criteria for SAEs, listed above.
8.9. Causality Assessment
The investigator’s assessment of causality must be provided for all AEs (serious and
non-serious); the investigator must record the causal relationship in the CRF/DCT, as
appropriate, and report such an assessment in accordance with the SAE reporting
requirements if applicable.  An investigator’s causality assessment is the determination of
whether there exists a reasonable possibility that the investigational product caused or
contributed to an AE; generally the facts (evidence) or arguments to suggest a causal
relationship should be provided.  If the investigator does not know whether or not the
investigational product caused the event, then the event will be handled as “related to
investigational product” for reporting purposes, as defined by the Sponsor (see the section on
Reporting Requirements).  If the investigator's causality assessment is "unknown but not
related to investigational product," this should be clearly documented on study records.
In addition, if the investigator determines that an SAE is associated with study procedures,
the investigator must record this causal relationship in the source documents and CRF/DCT,
as appropriate, and report such an assessment in accordance with the SAE reporting
requirements, if applicable.
8.10. Exposure During Pregnancy
For both unapproved/unlicensed products and for marketed products, an exposure during
pregnancy (EDP) occurs if:
1. A female becomes, or is found to be, pregnant either while receiving or having been
exposed (eg, because of treatment or environmental exposure) to the investigational
product; or the female becomes, or is found to be pregnant after discontinuing
and/or being exposed to the investigational product.
An example of environmental exposure would be a case involving direct contact with
a Pfizer product in a pregnant woman (eg, a nurse reports that she is pregnant and has
been exposed to chemotherapeutic products).
2. A male has been exposed (eg, because of treatment or environmental exposure) to
the investigational product prior to or around the time of conception and/or is
exposed during his partner’s pregnancy.
If a study subject or study subject’s partner becomes or is found to be pregnant during the
study subject’s treatment with the investigational product, the investigator must submit this
information to the Pfizer drug safety unit on an SAE Report Form and an EDP supplemental
form, regardless of whether an SAE has occurred.  In addition, the investigator must submit
information regarding environmental exposure to a Pfizer product in a pregnant woman (eg, a
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or spillage) using the EDP Supplemental Form.  This must be done irrespective of whether an
AE has occurred and within 24 hours of awareness of the exposure.  The information
submitted should include the anticipated date of delivery (see below for information related
to termination of pregnancy).
Follow-up is conducted to obtain general information on the pregnancy and its outcome for
all EDP reports with an unknown outcome.  The investigator will follow the pregnancy until
completion (or until pregnancy termination) and notify Pfizer of the outcome as a follow-up 
to the initial EDP Supplemental Form.  In the case of a live birth, the structural integrity of
the neonate can be assessed at the time of birth.  In the event of a termination, the reason(s)
for termination should be specified and, if clinically possible, the structural integrity of the
terminated fetus should be assessed by gross visual inspection (unless preprocedure test
findings are conclusive for a congenital anomaly and the findings are reported).
If the outcome of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy,
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in a
live-born baby, a terminated fetus, an intrauterine fetal demise or a neonatal death]), the
investigator should follow the procedures for reporting SAEs.
Additional information about pregnancy outcomes that are reported as SAEs follows:

“Spontaneous abortion” includes miscarriage and missed abortion;

Neonatal deaths that occur within 1 month of birth should be reported, without regard
to causality, as SAEs.  In addition, infant deaths after 1 month should be reported as
SAEs when the investigator assesses the infant death as related or possibly related to
exposure to the investigational product.
Additional information regarding the EDP may be requested by the investigator.  Further
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on
preterm infants to identify developmental delays).  In the case of paternal exposure, the
investigator will provide the study subject with the Pregnant Partner Release of Information
Form to deliver to his partner.  The Investigator must document in the source documents that
the subject was given the Pregnant Partner Release of Information Form to provide to his
partner.
8.11. Occupational Exposure
An occupational exposure occurs when during the performance of job duties, a person
(whether a healthcare professional or otherwise) gets in unplanned direct contact with the
product, which may or may not lead to the occurrence of an AE.
An occupational exposure is reported to the drug safety unit within 24 hours of the
investigator’s awareness, using the SAE report form, regardless of whether there is an
associated AE/SAE.  Since the information does not pertain to a subject enrolled in the study,
the information is not reported on a CRF/DCT; however a copy of the completed SAE report
form is maintained in the investigative site file.

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8.12. Withdrawal Due to Adverse Events (see also the section on Subject Withdrawal)
Withdrawal due to AEs should be distinguished from withdrawal due to other causes,
according to the definition of AE noted earlier, and recorded on the appropriate AE
CRF/DCT page.
When a subject withdraws because of an SAE, the SAE must be reported in accordance with
the reporting requirements defined below.
8.13. Eliciting Adverse Event Information
The investigator is to report all directly observed AEs and all AEs spontaneously reported by
the study subject.  In addition, each study subject will be questioned about AEs.
8.14. Reporting Requirements
Each AE is to be assessed to determine if it meets the criteria for SAEs.  If an SAE occurs,
expedited reporting will follow local and international regulations, as appropriate.
8.14.1. Serious Adverse Event Reporting Requirements
If an SAE occurs, Pfizer is to be notified within 24 hours of investigator awareness of the
event.
In particular, if the SAE is fatal or life-threatening, notification to Pfizer must be made
immediately, irrespective of the extent of available AE information.  This time frame also
applies to additional new information (follow-up) on previously forwarded SAE reports as
well as to the initial and follow-up reporting of EDP, exposure via breastfeeding and
occupational exposure cases.
In the rare event that the investigator does not become aware of the occurrence of an SAE
immediately (eg, if an outpatient study subject initially seeks treatment elsewhere), the
investigator is to report the event within 24 hours after learning of it and document the time
of his or her first awareness of the AE.
For all SAE, the investigator is obligated to pursue and provide information to Pfizer in
accordance with the time frames for reporting specified above.  In addition, an investigator
may be requested by Pfizer to obtain specific additional follow-up information in an
expedited fashion.  This information collected for SAEs is more detailed than that captured
on the AE CRF/DCT.  In general, this will include a description of the AE in sufficient detail
to allow for a complete medical assessment of the case and independent determination of
possible causality.  Information on other possible causes of the event, such as concomitant
medications, vaccines, and/or illnesses, must be provided.  In the case of a subject death, a
summary of available autopsy findings must be submitted as soon as possible to Pfizer or its
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8.14.2. Nonserious Adverse Event Reporting Requirements
All AEs will be reported on the AE page(s) of the CRF/DCT.  It should be noted that the
form for collection of SAE information is not the same as the AE CRF/DCT.  Where the
same data are collected, the forms must be completed in a consistent manner.  For example,
the same AE term should be used on both forms.  AE should be reported using concise
medical terminology on the CRFs/DCTs as well as on the form for collection of SAE
information.
8.14.3. Sponsor’s Reporting Requirements to Regulatory Authorities
AE reporting, including suspected unexpected serious adverse reactions, will be carried out
in accordance with applicable local regulations.
9. DATA ANALYSIS/STATISTICAL METHODS
Detailed methodology for summary and statistical analyses of the data collected in this study
are outlined here and further detailed in a Statistical Analysis Plan (SAP), which will be
maintained by the sponsor.  The Statistical Analysis Plan may modify what is outlined in the
protocol where appropriate; however, any major modifications of the primary endpoint
definitions or their analyses will also be reflected in a protocol amendment.
 
The study will be divided into two parts.  Part 1 is the healthy subject section while Part 2
will include the patient cohorts.  Results of Parts 1 and 2 will be summarized and displayed
in separate tables when appropriate.  Results from the SAD and multiple dose portions of
Part 1 may also be displayed in separate tables as appropriate.
An additional Part 3 with AD subjects is included as part of Protocol Amendment #4.
Results will be summarized and displayed in separate tables when appropriate.
In addition, summarizations of unblinded preliminary safety, PK, 
 may be performed
for each part after Week 12 safety, PK, and 
have been obtained from a majority of 
subjects in that Part, as applicable, but prior to the end of the study and full safety follow-up.
Further details will be defined in the SAP. 
9.1. Sample Size Determination
For Parts 1 and 2, the sample size of approximately 56 healthy subjects (up to 80 if separate
multiple dose cohorts are needed) and up to approximately 35 patients with CRSwNP, for a 
total of up to approximately 91 subjects (up to 115 with separate multiple dose cohorts), was
based on the clinical considerations to provide safety, tolerability information and
pharmacological considerations and on the desire to minimize exposure to healthy subjects at
each dose level.  Early withdrawals may be replaced to ensure sufficient subjects at each dose
level to adequately assess safety and PK information and to provide a placebo group
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comparison group.  No formal statistical testing will be applied to the safety, PK
data.
For Part 3, the sample size of approximately 20 subjects with moderate to severe AD was
based on the clinical considerations to provide safety, tolerability, and 
 
information, and on the desire to minimize exposure to AD subjects before the safety and 
tolerability of PF-06817024 in subjects with AD is established.  Additional subjects up to a 
total of approximately 32 will be
 
Early withdrawals may be replaced to ensure sufficient subjects at each dose level 
to assess safety, PK 
 information adequately and to provide a placebo group 
comparison group.  No formal statistical testing will be applied to the safety, PK or 
.
9.2. Efficacy Analysis
Efficacy analysis is not applicable to this study.
9.3. Pharmacokinetic Analysis
The PK concentration population will be defined as all randomized subjects who received at
least 1 dose of PF-06817024 and in whom at least 1 concentration value is reported. The PK
parameter analysis population is defined as all enrolled subjects who received at least 1 dose
of PF-06817024 and in whom at least one of the PK parameters of interest is calculated.
PK parameters for PF-06817024 following single and multiple dose administration will be
derived from the concentration-time profiles by non-compartmental analysis. The PK 
parameters are defined in Table 9.
Table 9.
Definition of PK Parameters in Study C0341001
Parameter
Definition
Period†
Method of Determination
Cmax
Maximum serum 
concentration
SD/MD
Observed directly from data
Cmax(dn)
Dose normalized Cmax
SD/MD
Cmax/Dose
Cmin
Trough serum 
concentration
MD
Observed directly from data
Tmax
Time for Cmax
SD/MD
Observed directly from data as time of first
occurrence
AUClast
Area under the plasma
concentration-time
profile over the dosing
interval τ
SD
Linear/Log trapezoidal method
AUCinf*
Area under the plasma
concentration-time
profile from zero to 
infinity
SD
Linear/Log trapezoidal method
AUCtau
Area under curve within 
dosing interval, τ = 720 
hr for single dose cohort
MD
Linear/Log Trapezoidal method
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Table 9.
Definition of PK Parameters in Study C0341001
Parameter
Definition
Period†
Method of Determination
AUCtau(dn)
Dose normalized AUCtau
MD
AUCtau/Dose
Cav
Average concentration 
over dosing interval
MD
AUCtau /tau
CL* (IV 
only)
Clearance
SD
Dose / AUCinf
Vss* (IV 
only)
Volume of distribution at
steady state
SD
AUMCinf/AUCinf*CL
CL/F* (SC 
only)
Apparent clearance
SD
Dose/AUCinf
Vz/F* (SC 
only)
Apparent volume of
distribution
SD
Dose/(AUCinf⋅kel)
t1/2*
Terminal elimination
half-life
SD/MD
Loge(2)/kel, where kel is the terminal phase rate 
constant calculated by a linear regression of the 
log-linear concentration-time curve.  Only those 
data points judged to describe the terminal log-linear 
decline will be used in the regression.
Rac, AUCtau
Accumulation ratio for
AUCtau
MD
AUCtau last dose/AUCtau first dose
Rac, Cmax
Accumulation ratio for
Cmax
MD
Cmax last dose/Cmax first dose
† Period column defines whether a parameter should be calculated after single dosing (SD), multiple dosing (MD), or 
both (SD/MD).
*As data permits.
The concentration of PF-06817024 will be descriptively summarized and plotted by PK
sampling time and treatment group.  PK parameters will be descriptively summarized by
treatment group.
Dose normalized AUCtau, and Cmax will be plotted against dose (using a logarithmic scale).  
The plot will include individual subject values and the geometric means for each dose. These
plots will be used to help understand the relationship between the PK parameters and dose.
 
 
 
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9.6. Safety Analysis
TEAEs, withdrawals due to TEAEs, treatment emergent SAEs, ECGs, vital sign parameters,
and safety laboratory data will be reviewed and summarized on an ongoing basis during the
study to evaluate the safety of subjects.  Any clinical laboratory, ECG, or vital sign
abnormalities of potential clinical concern will be described.  Safety data will be presented in
tabular and/or graphical format and summarized descriptively, where appropriate.
Immunogenicity (ADA, NAb) results will be listed and summarized by cohorts and time
points.  Subject level immune response will also be summarized by cohorts.  Effect of
positive ADA and neutralizing immune response on safety,
and PK may be assessed, if
appropriate.
Medical history, physical examination, continuous cardiac monitoring per SoA, and
neurologic examination information, as applicable, collected during the course of the study
will be considered source data and will not be required to be reported, unless otherwise
noted.  However, any untoward findings identified on continuous cardiac monitoring per 
SoA, physical and/or neurologic examinations conducted after the administration of the first
dose of study medication will be captured as an adverse event, if those findings meet the
definition of an adverse event.  Data collected at Screening that is used for
inclusion/exclusion criteria, such as laboratory data, ECGs and vital signs will be considered
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source data, and will not be required to be reported, unless otherwise noted.  Demographic
data collected at Screening will be reported.
Part 3 safety analyses will be done as described above.
9.6.1. Electrocardiogram (ECG) Analysis
Abnormal and clinical relevant changes for the ECG parameters QT interval, heart rate, QTc
interval, PR interval and QRS interval will be summarized by treatment and time.
The number (%) of subjects with maximum post dose QTc values and maximum increases
from baseline in the following categories will be tabulated by treatment:
Safety QTc
Borderline (msec)
Prolonged (msec)
Absolute Value
≥450 - <480
≥480
Absolute Change
30-<60
≥60
In addition, the number of subjects with corrected and uncorrected QT values ≥500 msec will
be summarized.
If more than one ECG is collected at a nominal time post dose (for example, triplicate
ECGs), the mean of the replicate measurements will be used to represent a single observation
at that time point.  If any of the three individual ECG tracings has a QTc value ≥500 msec,
but the mean of the triplicates is not ≥500 msec, the data from the subject’s individual tracing
will be described in a safety section of the study report in order to place the ≥500 msec value
in appropriate clinical context.  However, values from individual tracings within triplicate
measurements that are ≥500 msec will not be included in the categorical analysis unless the
average from the triplicate measurements is also ≥500 msec.  Changes from baseline will be
defined as the change between QTc post dose from the time-matched average baseline
triplicates on Day 0, or the average of the pre-dose triplicate values on Day 1.
Part 3 ECG data analysis will be done as described above.
9.7. Interim Analysis
No formal interim analysis will be conducted for this study.  However, as this is a
sponsor-open study, the Sponsor may conduct unblinded reviews of the data during the
course of the study for the purpose of safety assessment, facilitating dose-escalation
decisions, facilitating PK/
modeling, and/or to support clinical development.  Unblinded
results will be reviewed by a designated limited number of Sponsor colleagues within the
study team.  Refer to the study’s Data Blinding Plan and/or Statistical Analysis Plan for
specific details including delineation of study team members who will be involved in these
unblinded reviews as well as steps to be instituted ahead of initiation of any unblinded review
to ensure study integrity is maintained.
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9.8. Data Monitoring Committee
This study will not use a data monitoring committee.
10. QUALITY CONTROL AND QUALITY ASSURANCE
Pfizer or its agent will conduct periodic monitoring visits during study conduct for studies
conducted at non-Pfizer study sites, to ensure that the protocol and Good Clinical Practices
(GCPs) are being followed.  The monitors may review source documents to confirm that the
data recorded on CRFs/DCTs are accurate.  The investigator and institution will allow Pfizer
monitors/auditors or its agents and appropriate regulatory authorities direct access to source
documents to perform this verification.  This verification may also occur after study
completion.
During study conduct and/or after study completion, the study site may be subject to review
by the institutional review board (IRB)/ethics committee (EC), and/or to quality assurance
audits performed by Pfizer, or companies working with or on behalf of Pfizer, and/or to
inspection by appropriate regulatory authorities.
The investigator(s) will notify Pfizer or its agents immediately of any regulatory inspection
notification in relation to the study.  Furthermore, the investigator will cooperate with Pfizer
or its agents to prepare the study site for the inspection and will allow Pfizer or its agent,
whenever feasible, to be present during the inspection.  The investigator will promptly
provide copies of the inspection findings to Pfizer or its agent.  Before response submission
to the regulatory authorities, the investigator will provide Pfizer or its agents with an
opportunity to review and comment on responses to any such findings.
For studies conducted at non-Pfizer study sites, it is important that the investigator(s) and
their relevant personnel are available during the monitoring visits and possible audits or
inspections and that sufficient time is devoted to the process.
11. DATA HANDLING AND RECORD KEEPING
11.1. Case Report Forms/Data Collection Tools/Electronic Data Record
As used in this protocol, the term CRF/DCT should be understood to refer to either a paper
form or an electronic data record or both, depending on the data collection method used in
this study.
A CRF/DCT is required and should be completed for each included subject.  The completed
original CRFs/DCTs are the sole property of Pfizer and should not be made available in any
form to third parties, except for authorized representatives of Pfizer or appropriate regulatory
authorities, without written permission from Pfizer.
The investigator has ultimate responsibility for the collection and reporting of all clinical,
safety, and laboratory data entered on the CRFs/DCTs and any other data collection forms
(source documents) and ensuring that they are accurate, authentic/original, attributable,
complete, consistent, legible, timely (contemporaneous), enduring, and available when
required.  The CRFs/DCTs must be signed by the investigator or by an authorized staff

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member to attest that the data contained on the CRFs/DCTs is true.  Any corrections to
entries made in the CRFs/DCTs or source documents must be dated, initialed and explained
(if necessary) and should not obscure the original entry.
In most cases the source documents are the hospital or the physician's chart.  In these cases,
data collected on the CRFs/DCTs must match those charts.
In some cases, the CRF/DCT may also serve as the source document.  In these cases, a
document should be available at the investigative site as well as at Pfizer and clearly identify
those data that will be recorded in the CRF/DCT, and for which the CRF/DCT will stand as
the source document.
11.2. Record Retention
To enable evaluations and/or audits from regulatory authorities or Pfizer, the investigator
agrees to keep records, including the identity of all participating subjects (sufficient
information to link records, eg, CRFs/DCTs and hospital records), all original signed
informed consent documents, copies of all CRFs/DCTs, safety reporting forms, source
documents, detailed records of treatment disposition, and adequate documentation of relevant
correspondence (eg, letters, meeting minutes, and telephone call reports).  The records should
be retained by the investigator according to the ICH guidelines, according to local
regulations, or as specified in the clinical study agreement (CSA), whichever is longer.
If the investigator becomes unable for any reason to continue to retain study records for the
required period (eg, retirement, relocation), Pfizer should be prospectively notified.  The
study records must be transferred to a designee acceptable to Pfizer, such as another
investigator, another institution, or to an independent third party arranged by Pfizer.
Investigator records must be kept for a minimum of 15 years after completion or
discontinuation of the study or for longer if required by applicable local regulations.
The investigator must obtain Pfizer's written permission before disposing of any records,
even if retention requirements have been met.
12. ETHICS
12.1. Institutional Review Board / Ethics Committee
It is the responsibility of the investigator to have prospective approval of the study protocol,
protocol amendments, informed consent documents, and other relevant documents,
eg, recruitment advertisements, if applicable, from the IRB/EC.  All correspondence with the
IRB/EC should be retained in the investigator file.  Copies of IRB/EC approvals should be
forwarded to Pfizer.
The only circumstance in which an amendment may be initiated prior to IRB/EC approval is
where the change is necessary to eliminate apparent immediate hazards to the subjects.  In
that event, the investigator must notify the IRB/EC and Pfizer in writing immediately after
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12.2. Ethical Conduct of the Study
The study will be conducted in accordance with legal and regulatory requirements, as well as
the general principles set forth in the International Ethical Guidelines for Biomedical
Research Involving Human Subjects (Council for International Organizations of Medical
Sciences 2002), Guidelines for Good Clinical Practice (GCP) (ICH 1996), and the
Declaration of Helsinki (World Medical Association 1996 and 2008).
In addition, the study will be conducted in accordance with the protocol, the ICH guideline
on GCP, and applicable local regulatory requirements and laws.
12.3. Subject Information and Consent
All parties will ensure protection of subject personal data and will not include subject names
or other identifiable data in any reports, publications, or other disclosures, except where
required by laws.
When study data are compiled for transfer to Pfizer and other authorized parties, subject
names, addresses,  and other identifiable data will be replaced by numerical codes based on a
numbering system provided by Pfizer in order to de-identify study subjects.  The study site
will maintain a confidential list of subjects who participated in the study, linking each
subject’s numerical code to his or her actual identity.  In case of data transfer, Pfizer will
maintain high standards of confidentiality and protection of subjects’ personal data consistent
with applicable privacy laws.
The informed consent documents must be in compliance with ICH GCP, local regulatory
requirements, and legal requirements, including applicable privacy laws.
The informed consent documents used during the informed consent process must be
reviewed and approved by the sponsor, approved by the IRB/EC before use, and available for
inspection.
The investigator must ensure that each study subject is fully informed about the nature and
objectives of the study and possible risks associated with participation.
The investigator, or a person designated by the investigator, will obtain written informed
consent from each subject before any study-specific activity is performed.  The investigator
will retain the original of each subject's signed consent document.
12.4. Subject Recruitment
Advertisements approved by IRBs/ECs and investigator databases may be used as
recruitment procedures.  Use of ethics committee approved, generic, prescreening
questionnaire to assess basic subject characteristics to determine general eligibility for this
study is allowed.  This generic questionnaire may be used by sites as a phone script and/or to
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Pfizer will have an opportunity to review and approve the content of any study recruitment
materials directed to potential study subjects before such materials are used.
12.5. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable
competent authority in any area of the world, or if the investigator is aware of any new
information that might influence the evaluation of the benefits and risks of the investigational
product, Pfizer should be informed immediately.
In addition, the investigator will inform Pfizer immediately of any urgent safety measures
taken by the investigator to protect the study subjects against any immediate hazard, and of
any serious breaches of this protocol or of ICH GCP that the investigator becomes aware of.
13. DEFINITION OF END OF TRIAL
13.1. End of Trial in United States
Last subject last visit (LSLV) is defined as the date the investigator reviews the last subject’s
final safety data and determines that no further evaluation is required for the subject to
complete the trial.
14. SPONSOR DISCONTINUATION CRITERIA
Premature termination of this study may occur because of a regulatory authority decision,
change in opinion of the IRB/EC, or investigational product safety problems, or at the
discretion of Pfizer.  In addition, Pfizer retains the right to discontinue development of
PF-06817024 at any time.
If a study is prematurely terminated, Pfizer will promptly notify the investigator.  After
notification, the investigator must contact all participating subjects and the hospital pharmacy
(if applicable) within 7 days.  As directed by Pfizer, all study materials must be collected and
all CRFs/DCTs completed to the greatest extent possible.
15. PUBLICATION OF STUDY RESULTS
15.1. Communication of Results by Pfizer
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the European Clinical Trials
Database (EudraCT), and/or www.pfizer.com, and other public registries in accordance with
applicable local laws/regulations.
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and
complete manner and are reported regardless of the outcome of the study or the country in
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www.clinicaltrials.gov
Pfizer posts clinical trial US basic results on www.clinicaltrials.gov for Pfizer-sponsored
interventional studies conducted in patients that evaluate the safety and/or efficacy of a Pfizer
product, regardless of the geographical location in which the study is conducted.  US Basic
Results are submitted for posting within 1 year of the primary completion date for studies in
adult populations or within 6 months of the primary completion date for studies in pediatric
populations.
Primary completion date is defined as the date that the final subject was examined or
received an intervention for the purposes of final collection of data for the primary outcome,
whether the clinical study concluded according to the prespecified protocol or was
terminated.
EudraCT
Pfizer posts European Union (EU) Basic Results on EudraCT for all Pfizer-sponsored
interventional studies that are in scope of EU requirements.  EU Basic Results are submitted
for posting within 1 year of the primary completion date for studies in adult populations or
within 6 months of the primary completion date for studies in pediatric populations.
www.pfizer.com
Pfizer posts public disclosure synopses (clinical study report synopses in which any data that
could be used to identify individual patients have been removed) on www.pfizer.com for
Pfizer-sponsored interventional studies at the same time the US Basic Results document is
posted to www.clinicaltrials.gov.
15.2. Publications by Investigators
Pfizer supports the exercise of academic freedom and has no objection to publication by a
principal investigator of the results of the study based on information collected or generated
by a principal investigator, whether or not the results are favorable to the Pfizer product.  
However, to ensure against inadvertent disclosure of confidential information or unprotected
inventions, the investigator will provide Pfizer an opportunity to review any proposed
publication or other type of disclosure of the results of the study (collectively, “publication”)
before it is submitted or otherwise disclosed.
The investigator will provide any publication to Pfizer at least 30 days before they are
submitted for publication or otherwise disclosed.  If any patent action is required to protect
intellectual property rights, the investigator agrees to delay the disclosure for a period not to
exceed an additional 60 days.
The investigator will, on request, remove any previously undisclosed confidential
information before disclosure, except for any study- or Pfizer product-related information
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If the study is part of a multi-center study, the investigator agrees that the first publication is
to be a joint publication covering all study sites, and that any subsequent publications by the 
principal investigator will reference that primary publication.  However, if a joint manuscript
has not been submitted for publication within 12 months of completion or termination of the
study at all participating sites, the investigator is free to publish separately, subject to the
other requirements of this section.
For all publications relating to the study, institution will comply with recognized ethical
standards concerning publications and authorship, including Section II - “Ethical
Considerations in the Conduct and Reporting of Research” of the Uniform Requirements for
Manuscripts Submitted to Biomedical Journals, http://www.icmje.org/index.html#authorship,
established by the International Committee of Medical Journal Editors.
Publication of study results is also provided for in the CSA between Pfizer and the
institution.  In this section entitled Publications by Investigators, the defined terms shall have
the meanings given to them in the CSA.
If there is any conflict between the CSA and any attachments to it, the terms of the CSA
control.  If there is any conflict between this protocol and the CSA, this protocol will control
as to any issue regarding treatment of study subjects, and the CSA will control as to all other
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Lipozencic, T. Luger, A. P. Oranje, T. Schafer, T. Schwennesen, S. Seidenari, D. 
Simon, S. Stander, G. Stingl, S. Szalai, J. C. Szepietowski, A. Taieb, T. Werfel, A. 
Wollenberg, U. Darsow, F. European Dermatology, D. European Academy of, 
Venereology, A. European Federation of, D. European Task Force on Atopic, D. 
European Society of Pediatric, A. Global and N. Asthma European (2012). "Guidelines 
for treatment of atopic eczema (atopic dermatitis) part I." J Eur Acad Dermatol 
Venereol 26(8): 1045-1060.
 
 
 
63.
Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, et al. (2001) The eczema area 
and severity index (EASI): assessment of reliability in atopic dermatitis. EASI 
Evaluator Group. Exp Dermatol 10: 11–18.JM HanifinM. ThurstonM. OmotoR. 
CherillSJ Tofte2001The eczema area and severity index (EASI): assessment of 
reliability in atopic dermatitis. EASI Evaluator Group.Exp Dermatol101118.
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64.
Siegfried E, Korman N, Molina C, Kianifard F, Abrams K (2006) Safety and efficacy of 
early intervention with pimecrolimus cream 1% combined with corticosteroids for 
major flares in infants and children with atopic dermatitis. J Dermatolog Treat 17: 
143-150.E. SiegfriedN. KormanC. MolinaF. KianifardK. Abrams2006Safety and 
efficacy of early intervention with pimecrolimus cream 1% combined with 
corticosteroids for major flares in infants and children with atopic dermatitis.J 
Dermatolog Treat17143150.
 
66.
Posner, K., M. A. Oquendo, M. Gould, B. Stanley and M. Davies (2007). "Columbia 
Classification Algorithm of Suicide Assessment (C-CASA): Classification of Suicidal 
Events in the FDA’s Pediatric Suicidal Risk Analysis of Antidepressants." The 
American journal of psychiatry 164(7): 1035-1043.
 
 
 
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Appendix 3. Nasal Polyp Score (NPS)44
Polyp Score
Polyp Size
0
No polyps
1
Small polyps in the middle meatus not reaching below the inferior border
of the middle turbinate
2
Polyps reaching below the lower border of the middle turbinate
3
Large polyps reaching the lower border of the inferior turbinate or polyps
medial to the middle turbinate
4
Large polyps causing complete obstruction of the inferior nasal cavity
Each side’s Nasal Polyp Score (0-4) will be determined for each side (left, right).
Bilateral NPS (0-8) = left NPS (0-4) + right NPS (0-4).

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Appendix 5. Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
 
AD
Atopic Dermatitis
ADA
Anti drug antibody
AE
Adverse event
Abs
Absolute
ALT
Alanine transaminase
ANCOVA
Analysis of covariance
AST
Aspartate transaminase
ATS/ERS
American Thoracic Society/European Respiratory Society
AUC
Area under the curve
AUC24
Area under the concentration-time curve from time 0 to 24 hours
AUC504
Area under the concentration-time curve from time 0 to 504 hours
AUCinf
Area under the concentration-time profile from time zero to infinity
AUClast
Area under the concentration-time profile from time zero to the time 
of the last quantifiable concentration
AUCtau
Area under the concentration–time curve within dosing interval
BMI
Body mass index
BP
Blood pressure
BPM
Beats per minute
BSA
Body Region Surface Area
BUN
Blood urea nitrogen
Cav
Average concentration over dosing interval
CDRs
Complementarity-determining regions
CL
Clearance
CL/F
Apparent clearance
Cmax
Maximum observed concentration
CO2
Carbon dioxide (bicarbonate)
CRF
Case report form
CRS
Chronic rhinosinusitis
CRSwNP
Chronic rhinosinusitis with nasal polyps
CRU
Clinical Research Unit
CSA
Cyclosporine A
CSA
Clinical study agreement
CSR
Clinical study report
CSSR-S
Columbia Suicide Severity Rating Scale 
CT
Computerized axial tomography
CV
Cardiovascular
DAI
Dosage and administration instructions
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Abbreviation
Term
DCT
Data collection tool
DCF
Data Clarification Form
dn
Dose normalized
DNA
Deoxyribonucleic acid
EASI
Eczema and Severity Index
EC
Ethics committee
ECG
Electrocardiogram
EDP
Exposure during pregnancy
EDTA
Edetic acid (ethylenediaminetetraacetic acid)
ENT
Ear, nose and throat
EudraCT
European Clinical Trials Database
EU
European Union
FDA
Food and Drug Administration (United States)
FEV1
Forced expiratory volume in one second
FIH
First in Human
FSH
Follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
Gamma-glutamyl transpeptidase
GLP
Good Laboratory Practice
GM-CSF
Granulocyte-macrophage colony stimulating factor
HBcAb
Hepatitis B core antibody
HBsAb
Hepatitis B surface antibody
HBsAg
Hepatitis B surface antigen
HCV Ab
Anti-Hepatitis C antibody
HED
Human equivalent dose
HIV
Human immunodeficiency virus
Hs-CRP
High Sensitivity C-Reactive Protein
IFN-γ
Interferon-gamma
IGA
Investigator Global Assessment
IP
Investigational Product
IB
Investigator’s brochure
IC50
Half maximal inhibitory concentration
ICH
International Conference on Harmonisation
ID
Identification
IgE
Immunoglobulin E
IgG1
Immunoglobulin Gamma 1
IL
Interleukin
IL1RL1
Interleukin 1 Receptor-Like 1
ILCs
Innate lymphoid cells
IND
Investigational new drug
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Abbreviation
Term
INR
International normalized ratio
IRB
Institutional review board
ISR
Injection site-reactions
IUD
Intrauterine device
IV
Intravenous
JAK
Janus Kinase
K2EDTA
Potassium salt ethylenediaminetetraacetic acid
LFT
Liver function test
LSLV
Last subject last visit 
mAB
Monoclonal antibody
MCH
Mean corpuscular hemoglobin
MCHC
Mean corpuscular hemoglobin concentration
MCV
Mean corpuscular volume
MedDRA
Medical Dictionary for Regulatory Activities 
MD
Multiple dose
MTX
Methotrexate
mm2
IL-33 amino acids 112-270 with 4 cysteines changed to serine
MRT
Mean residence time
NAb
Neutralizing antibody
N/A
Not applicable
NB-UVB
Narrow Band Ultraviolet B
ND
Not determined
NHANES III
Third National Health and Nutrition Examination Survey
NK
Natural killer cells
NKT
Natural killer T-lymphocytes
NOAEL
No observed adverse effect level
NPS
Nasal polyp score
NSAIDs
Nonsteroidal anti-inflammatory drugs
Pbo
Placebo
PDE
Phosphodiesterase
PF
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PI
Principal investigator
PK
Pharmacokinetics
pM
Picomolar
PR
Pulse rate
PRO 
Patient Reported Outcome
PROM
Patient-reported outcome measure 
PT
Prothrombin time
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Abbreviation
Term
QTc
Corrected QT
Rac
Accumulation ratio 
RBC
Red blood cell
RR
Respiratory rate
SAD
Single ascending dose
SAE
Serious adverse event
SAP
Statistical analysis plan
SC
Subcutaneous
SD
Single dose
SCr
Serum creatinine
SGOT
Serum glutamic oxaloacetic transaminase
SGPT
Serum glutamic pyruvic transaminase
SNOT
Sino-Nasal Outcome Test
SoA
Schedule of Activities 
SOC
System Organ Classes
SOP
Standard Operating Procedure
SRSD
Single reference safety document
t½
Terminal half-life
Tmax
Time to reach maximum concentration
TB
Tuberculosis
TEAEs
Treatment emergent adverse events
Th2
T lymphocytes
THC
Tetrahydrocannabinol
TK
Toxicokinetics
ULN
Upper limit of normal
US
United States
UVA
Ultraviolet A
UVB
Ultraviolet B
Vss
Volume of distribution at steady state
Vz/F
Apparent volume of distribution
WBC
White blood cell
wt
Wild-type
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Appendix 6. Clinical Criteria for Diagnosing Anaphylaxis Guidance50
Anaphylaxis is highly likely when any one of the following 3 criteria are fulfilled:
1.
Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or 
both (eg, generalized hives, pruritus or flushing, swollen lips-tongue-uvula) 
AND AT LEAST ONE OF THE FOLLOWING
a.
Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, 
hypoxemia)
b.
Reduced BP or associated symptoms of end-organ dysfunction (eg, hypotonia [collapse], 
syncope, incontinence)
2.
Two or more of the following that occur rapidly after exposure to a likely allergen for that patient
(minutes to several hours):
a.
Involvement of the skin-mucosal tissue (eg, generalized hives, itch-flush, swollen 
lips-tongue-uvula)
b.
Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, 
hypoxemia)
c.
Reduced BP or associated symptoms (eg, hypotonia [collapse], syncope, incontinence)
d.
Persistent gastrointestinal symptoms (eg, crampy abdominal pain, vomiting)
3.
Reduced BP after exposure to known allergen for that patient (minutes to several hours):
a.
Infants and children: low systolic BP (age specific) or greater than 30% decrease in systolic 
BP*
b.
Adults: systolic BP of less than 90 mm Hg or greater than 30% decrease from that person’s 
baseline
PEF, Peak expiratory flow; BP, blood pressure.
*Low systolic blood pressure for children is defined as less than 70 mm Hg from 1 month to 1 year, less 
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Appendix 7. Fitzpatrick Skin Type

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Appendix 8. EASI
The EASI quantifies the severity of a subject’s atopic dermatitis based on both severity of 
lesion clinical signs and the percent of BSA affected.  EASI is a composite scoring by the 
atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, 
excoriation, and lichenification (each scored separately) for each of four body regions, with 
adjustment for the percent of BSA involved for each body region and for the proportion of 
the body region to the whole body.
Lesion Severity by Clinical Signs: The basic characteristics of atopic dermatitis lesions -
erythema, induration/papulation, excoriation, and lichenification - provide a means for 
assessing the severity of lesions.  Assessment of these four main clinical signs is performed 
separately for four body regions: head and neck, upper limbs, trunk (including axillae and 
groin) and lower limbs (including buttocks).  Average erythema, induration/papulation, 
excoriation, and lichenification are scored for each body region according to a 4 point scale: 
0 = absent; 1 = mild; 2 = moderate; 3 = severe.  Morphologic descriptors for each clinical 
sign severity score are shown in Table 10. 
Table 10.
Clinical Sign Severity Scoring Criteria for the Eczema Area and Severity 
Index (EASI)
Score
Description*
Erythema (E)
0
Absent
None; may have residual discoloration (post-inflammatory hyperpigmentation 
and/or hypopigmentation).
1
Mild
Light pink to light red
2
Moderate
Red
3
Severe
Deep, dark red
Induration/Papulation (I)
0
Absent
None
1
Mild
Barely palpable to slight, but definite hard thickened skin and/or papules
2
Moderate
Easily palpable moderate hard thickened skin and/or papules
3
Severe
Severe hard thickened skin and/or papules
Excoriation (Ex)
0
Absent
None
1
Mild
Slight, but definite linear or picked scratch marks or penetrating surface injury
2
Moderate
Moderate linear or picked scratch marks or penetrating surface injury
3
Severe
Severe linear or picked scratch marks or penetrating surface injury
Lichenification (L)
0
Absent
None
1
Mild
Barely perceptible to slight, but definite thickened skin, fine skin markings, 
and lichenoid scale
2
Moderate
Moderate thickened skin, coarse skin markings, and coarse lichenoid scale
3
Severe
Severe thickened skin with very coarse skin markings and lichenoid scale
The EASI will exclude scalp, palms, and soles from the assessment/scoring.

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Percent BSA with Atopic Dermatitis: The number of handprints of skin afflicted with 
atopic dermatitis in a body region can be used to determine the extent (%) to which a body 
region is involved with atopic dermatitis (Table 11).  When measuring, the handprint unit 
refers to the size of each individual subject’s hand with fingers in a closed position.
Table 11.
Handprint Determination of Body Region Surface Area (BSA)
Body Region
Total Number of Handprints 
in Body Region*
Surface Area of Body Region 
Equivalent of One Handprint*
Head and Neck
10
10%
Upper Limbs
20
5%
Trunk (including axillae and 
groin/genitals)
30
3.33%
Lower Limbs (including buttocks)
40
2.5%
Handprint refers to the hand size of each individual subject.
* The number of handprints will be for the entire body region; these values will not be adjusted for exclusion 
of scalp, palms, and soles from the BSA assessment.
The extent (%) to which each of the four body regions is involved with atopic dermatitis is 
categorized to a numerical Area Score using a non-linear scaling method according to the 
following BSA scoring criteria (Table 12).
Table 12.
Eczema Area and Severity Index (EASI) Area Score Criteria
Percent BSA with Atopic Dermatitis in a Body Region
Area Score
0%
0
>0 - <10%
1
10 - <30%
2
30 - <50%
3
50 - <70%
4
70 - <90%
5
90 - 100%
6
Body Region Weighting: Each body region is weighted according to its approximate 
percentage of the whole body (Table 11).
Table 13.
Eczema Area and Severity Index (EASI) Body Region Weighting
Body Region
Body Region Weighting
Head and Neck
0.1
Upper Limbs
0.2
Trunk (including axillae and groin/genitals)
0.3
Lower Limbs (including buttocks)
0.4
* No adjustment for body regions excluded for assessment
In each body region, the sum of the Clinical Signs Severity Scores for erythema, 
induration/papulation, excoriation, and lichenification is multiplied by the Area Score and by 
the Body Region Weighting to provide a body region value, which is then summed across all 
four body regions resulting in an EASI score as described in Equation 3.

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Equation 3: EASI = 0.1Ah(Eh+Ih+Exh+Lh) + 0.2Au(Eu+Iu+ExU+Lu) + 
0.3At(Et+It+Ext+Lt) + 0.4Al(El+Il+Exl+Ll)
A = Area Score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and 
neck; u = upper limbs; t = trunk; l = lower limbs
The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores 
representing greater severity of atopic dermatitis.  The EASI should be completed per 
SoA Table E. 

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Appendix 10. Investigator Global Assessment (IGA) Score
Score
Category
Description
0
Clear
Atopic dermatitis is cleared, except for any residual discoloration 
(post-inflammatory hyperpigmentation and/or hypopigmentation).
1
Almost 
Clear
Overall, the atopic dermatitis is not entirely cleared and remaining lesions 
are light pink (not including post inflammatory hyperpigmentation) and/or; 
have barely palpable hard thickened skin and/or papules and/or; have barely 
perceptible lichenification; excoriation and oozing/crusting are absent.
2
Mild
Overall, the atopic dermatitis consists of lesions that are light red; with 
slight, but definite hard thickened skin and/or papules; with slight, but 
definite linear or picked scratch marks or penetrating surface injury; with 
slight, but definite thickened skin, fine skin markings, and lichenoid scale; 
oozing/crusting is absent.
3
Moderate
Overall, the atopic dermatitis consists of lesions that are red; with easily 
palpable moderate hard thickened skin and/or papules; with moderate linear 
or picked scratch marks or penetrating surface injury; with moderate 
thickened skin, coarse skin markings, and coarse lichenoid scale; with slight 
oozing/crusting.
4
Severe
Overall, the atopic dermatitis consists of lesions that are deep, dark red; with 
severe hard thickened skin and/or papules; with severe linear or picked 
scratch marks or penetrating surface injury; with severe thickened skin with 
very coarse skin markings and lichenoid scale; with moderate to severe 
oozing/crusting.
The IGA will exclude scalp, palms, and soles from the assessment/scoring.

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Appendix 15. Columbia Suicide Severity Rating Scale (C-SSRS) 

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Appendix 16. Diagnostic Criteria for Atopic Dermatitis
A subject is to have a clinical diagnosis of atopic dermatitis according to the criteria of 
Hanifin and Rajka. 
Hanifin and Rajka’s Diagnostic Criteria for Atopic Dermatitis
Major Criteria (must have at least three)
Pruritus
Typical morphology and distribution:
Adults: flexural lichenification or linearity
Children and infants: involvement of facial and extensor surfaces
Chronic or relapsing dermatitis
Personal or family history of atopy
Minor Criteria (must have at least three)
Xerosis
Icthyosis/keratosis pilaris/palmer hyperlinearity
Immediate (type 1) skin test reactivity
Elevated serum IgE
Early age at onset
Tendency to skin infections (Staphylococcus aureus, herpes simplex)/impaired cellular 
immunity
Hand/foot dermatitis
Nipple eczema
Cheilitis
Conjunctivitis
Dennie-Morgan fold
Keratoconus
Anterior subcapsular cataracts
Orbital darkening
Facial pallor/erythema
Pityriasis alba
Anterior neck folds
Itch when sweating
Intolerance to wool and lipid solvents
Perifollicular accentuation
Food intolerance
Course influenced by environmental/emotional factors
White dermographism/delayed blanch

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