A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ZAVEGEPANT INTRANASAL ADMINISTRATION IN HEALTHY CHINESE ADULT PARTICIPANTS
Phase: PHASE1
Conditions: Healthy
Sponsor: Pfizer

PF-07930207
Protocol C5301009
Final Protocol, 20 Feb 2023
PFIZER CONFIDENTIAL
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Title Page
A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE 
PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ZAVEGEPANT 
INTRANASAL ADMINISTRATION IN HEALTHY CHINESE ADULT
PARTICIPANTS
Study Intervention Number:
PF-07930207
Study Intervention Name:
Zavegepant
US IND Number:
Not applicable
EudraCT/EU CT Number:
Not applicable
ClinicalTrials.gov ID:  
Not available
Pediatric Investigational Plan Number:
Not applicable
Protocol Number:
C5301009
Phase:
1
Brief Title: A Phase 1 Study to Investigate the Pharmacokinetics of Zavegepant 
Following Single Intranasal Administration in Healthy Chinese Adult Participants
This document and accompanying materials contain confidential information belonging to Pfizer. Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified.
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Document History
Document
Version Date
Original protocol
20 Feb 2023
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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................7
1. PROTOCOL SUMMARY.....................................................................................................8
1.1. Synopsis ....................................................................................................................8
1.2. Schema ....................................................................................................................12
1.3. Schedule of Activities .............................................................................................13
2. INTRODUCTION ...............................................................................................................16
2.1. Study Rationale .......................................................................................................16
2.2. Background .............................................................................................................16
2.2.1. Nonclinical Overview.................................................................................16
2.2.2. Clinical Overview.......................................................................................17
2.2.2.1. Safety overview.........................................................................17
2.2.2.2. Clinical Pharmacology Overview .............................................17
2.3. Benefit/Risk Assessment.........................................................................................18
2.3.1. Risk Assessment.........................................................................................19
2.3.2. Benefit Assessment.....................................................................................20
2.3.3. Overall Benefit/Risk Conclusion................................................................20
3. OBJECTIVES AND ENDPOINTS.....................................................................................20
4. STUDY DESIGN.................................................................................................................20
4.1. Overall Design.........................................................................................................20
4.2. Scientific Rationale for Study Design.....................................................................21
4.3. Justification for Dose ..............................................................................................21
4.4. End of Study Definition ..........................................................................................22
5. STUDY POPULATION......................................................................................................22
5.1. Inclusion Criteria.....................................................................................................22
5.2. Exclusion Criteria....................................................................................................23
5.3. Lifestyle Considerations..........................................................................................26
5.3.1. Contraception..............................................................................................26
5.3.2. Meals and Dietary Restrictions...................................................................27
5.3.3. Caffeine, Alcohol, and Tobacco .................................................................27
5.3.4. Activity .......................................................................................................27
5.4. Screen Failures ........................................................................................................27
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6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY.................................28
6.1. Study Intervention(s) Administered........................................................................28
6.1.1. Administration............................................................................................28
6.2. Preparation, Handling, Storage, and Accountability...............................................29
6.2.1. Preparation and Dispensing........................................................................30
6.3. Assignment to Study Intervention...........................................................................30
6.4. Blinding...................................................................................................................30
6.5. Study Intervention Compliance...............................................................................31
6.6. Dose Modification...................................................................................................31
6.7. Continued Access to Study Intervention After the End of the Study......................31
6.8. Treatment of Overdose............................................................................................31
6.9. Prior and Concomitant Therapy..............................................................................31
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................32
7.1. Discontinuation of Study Intervention ....................................................................32
7.2. Participant Discontinuation/Withdrawal From the Study.......................................33
7.2.1. Withdrawal of Consent...............................................................................33
7.3. Lost to Follow-up....................................................................................................34
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................34
8.1. Administrative Procedures ......................................................................................34
8.2. Efficacy Assessments..............................................................................................35
8.3. Safety Assessments .................................................................................................35
8.3.1. Physical Examinations................................................................................35
8.3.2. Nasal Inspection..........................................................................................36
8.3.3. Vital Signs ..................................................................................................36
8.3.3.1. Blood Pressure and Pulse Rate..................................................36
8.3.4. Electrocardiograms.....................................................................................36
8.3.5. Clinical Safety Laboratory Assessments ....................................................37
8.3.6. COVID-19 Specific Assessments...............................................................38
8.3.7. Pregnancy Testing ......................................................................................38
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................38
8.4.1. Time Period and Frequency for Collecting AE and SAE Information.......38
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8.4.1.1. Reporting SAEs to Pfizer Safety...............................................39
8.4.1.2. Recording Nonserious AEs and SAEs on the CRF...................39
8.4.2. Method of Detecting AEs and SAEs ..........................................................40
8.4.3. Follow-Up of AEs and SAEs......................................................................40
8.4.4. Regulatory Reporting Requirements for SAEs...........................................40
8.4.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................41
8.4.5.1. Exposure During Pregnancy......................................................41
8.4.5.2. Exposure During Breastfeeding ................................................42
8.4.5.3. Occupational Exposure .............................................................43
8.4.6. Cardiovascular and Death Events...............................................................43
8.4.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................43
8.4.8. Adverse Events of Special Interest.............................................................43
8.4.8.1. Lack of Efficacy........................................................................43
8.4.9. Medical Device Deficiencies......................................................................43
8.4.10. Medication Errors.....................................................................................43
8.5. Pharmacokinetics ....................................................................................................44
8.6. Genetics...................................................................................................................45
8.6.1. Specified Genetics ......................................................................................45
8.7. Biomarkers ..............................................................................................................45
8.8. Immunogenicity Assessments.................................................................................45
8.9. Health Economics ...................................................................................................45
9. STATISTICAL CONSIDERATIONS ................................................................................45
9.1. Statistical Hypotheses .............................................................................................46
9.2. Analysis Sets ...........................................................................................................46
9.3. Statistical Analyses .................................................................................................46
9.3.1. General Considerations...............................................................................46
9.3.2. Pharmacokinetic Analysis ..........................................................................47
9.3.2.1. Derivation of PK parameters.....................................................47
9.3.2.2. Statistical Methods for Pharmacokinetic Data..........................47
9.3.3. Safety Analyses ..........................................................................................48
9.3.3.1. Electrocardiogram Analyses......................................................48
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9.4. Interim Analyses .....................................................................................................48
9.5. Sample Size Determination.....................................................................................48
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................49
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............49
10.1.1. Regulatory and Ethical Considerations ....................................................49
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................49
10.1.2. Financial Disclosure .................................................................................50
10.1.3. Informed Consent Process ........................................................................50
10.1.4. Data Protection .........................................................................................51
10.1.5. Committees Structure ...............................................................................51
10.1.5.1. Data Monitoring Committee ...................................................51
10.1.6. Dissemination of Clinical Study Data ......................................................51
10.1.7. Data Quality Assurance ............................................................................52
10.1.8. Source Documents....................................................................................54
10.1.9. Study and Site Start and Closure ..............................................................55
10.1.10. Publication Policy...................................................................................55
10.1.11. Sponsor’s Medically Qualified Individual..............................................56
10.2. Appendix 2: Clinical Laboratory Tests .................................................................57
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting .....................................................................58
10.3.1. Definition of AE .......................................................................................58
10.3.2. Definition of an SAE ................................................................................59
10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period............................................................................60
10.3.4. Reporting of SAEs....................................................................................64
10.4. Appendix 4: Contraceptive and Barrier Guidance ................................................65
10.4.1. Male Participant Reproductive Inclusion Criteria....................................65
10.4.2. Female Participant Reproductive Inclusion Criteria.................................65
10.4.3. Woman of Childbearing Potential ............................................................65
10.4.4. Contraception Methods.............................................................................66
10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-Up Assessments .......68
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10.6. Appendix 6: ECG Findings of Potential Clinical Concern ...................................70
10.7. Appendix 7: Abbreviations ...................................................................................72
11. REFERENCES ..................................................................................................................75
LIST OF TABLES
Table 1.
Study Schedule of Assessment.................................................................13
Table 2.
PK Sampling Timepoints..........................................................................15
Table 3.
Plasma PK Parameters for Protocol C5301009........................................47
Table 4.
Protocol-Required Safety Laboratory Assessments .................................57
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1. PROTOCOL SUMMARY 
1.1. Synopsis 
Protocol Title: A Phase 1, Open-Label, Single Dose Study to Investigate the 
Pharmacokinetics, Safety and Tolerability of Zavegepant Intranasal Administration in 
Healthy Chinese Adult Participants
Brief Title: A Phase 1 Study to Investigate the Pharmacokinetics of Zavegepant Following 
Single Intranasal Administration in Healthy Chinese Adult Participants
Regulatory Agency Identification Number(s):
US IND Number:
Not applicable
EudraCT/EU CT Number:
Not applicable
ClinicalTrials.gov ID:  
Not available
Pediatric Investigational Plan Number:
Not applicable
Protocol Number:
C5301009
Phase:
1
Rationale: The purpose of the study is to evaluate the PK, safety, and tolerability of 
zavegepant following intranasal administration of 10 mg single dose in healthy Chinese adult 
participants. Results from this study will be used to support zavegepant 10 mg IN China 
registration for the acute treatment of migraine.
Objectives and Endpoints:
Objectives
Endpoints
Primary: 
Primary: 

To characterize the systemic exposure of 
zavegepant following IN administration of 
10 mg single dose in healthy Chinese adult 
participants.
Zavegepant plasma PK parameters: Cmax, 
AUClast, and AUCinf, as data permits
Secondary: 
Secondary: 

To assess the safety and tolerability of 
zavegepant following IN administration of 
10 mg single dose in healthy Chinese adult 
participants.

To characterize the plasma PK profile of 
zavegepant following IN administration of 
10 mg single dose in healthy Chinese adult 
participants.

AEs, clinical safety laboratory tests, vital 
signs (BP and PR), physical examinations, and 
12-lead ECGs.

Additional zavegepant plasma PK parameters: 
Tmax, t½, CL/F and Vz/F, as data permits
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Overall Design:
This is a Phase 1, open-label, single dose study to characterize the PK, safety and tolerability 
of zavegepant in healthy Chinese adults following a single intranasal dose of 10 mg. 
Approximately 12 eligible participants, ages of 18 to 55 years (inclusive), will be enrolled in 
the study. 
Screening evaluation will occur within 28 days prior to the study intervention administration 
(Day 1). Participants will be admitted to the CRU the day before Day 1 and will be kept 
under safety monitoring for 2 days at the CRU. Participants will receive 10 mg single dose of 
IN zavegepant on Day 1. The PK of zavegepant will be characterized following Day 1 
dosing. A telephone follow-up will be made 28-35 days after the single dose. 
This study will be conducted in a single center in China. 
In this study, if more than 2 participants prematurely discontinue for reasons unrelated to the 
safety of the investigational product, participants may be replaced, at the discretion of the PI 
and sponsor study team.
Number of Participants:
Approximately 12 participants will be enrolled in the study.
Note: "Enrolled" means a participant's, or their legally authorized representative’s, agreement 
to participate in a clinical study following completion of the informed consent process and
assignment to study intervention. A participant will be considered enrolled if the informed 
consent is not withdrawn prior to participating in any study activity. Potential participants 
who are screened for the purpose of determining eligibility for the study, but do not 
participate in the study, are not considered enrolled, unless otherwise specified by the 
protocol.
Study Population:
Key inclusion and exclusion criteria are listed below:
Inclusion Criteria 
Participants must meet the following key inclusion criteria to be eligible for enrollment into 
the study:
1. Male or female Chinese participants, between the ages of 18 and 55 years, inclusive, 
at the time of signing the ICD. 

Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female 
(Section 10.4.2) participants. 
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2. Male and female Chinese participants who are overtly healthy as determined by 
medical evaluation
3. BMI of 18.0 to 30.0 kg/m2; and a total body weight ≥50.0 kg (110 lb) for males and 
≥45.0 kg (99 lb) for females. 
4. Non-smoker (no use of tobacco or nicotine products within 3 months prior to
screening).
5. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the ICD and in 
this protocol.
Exclusion Criteria 
Participants with any of the following characteristics/conditions will be excluded:
1.
Evidence or history of clinically significant hematological, renal, endocrine, 
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or 
allergic disease (including drug allergies, but excluding untreated, asymptomatic, 
seasonal allergies at the time of dosing).
2.
Clinically significant history of nasal conditions that may affect the administration 
or absorption of the nasal product. 
3.
Other medical or psychiatric condition that may increase the risk of study 
participation or, in the investigator’s judgment, make the participant inappropriate 
for the study.
4.
Evidence of organ dysfunction or any clinically significant deviation from normal 
in physical examination, nasal inspection, vital signs, 12-lead ECG, or clinical 
laboratory determinations beyond what is consistent with the target population.
5.
Positive result for COVID-19 at the time of Screening and admission.
6.
Refer to Section 6.9 Prior and Concomitant Therapy. Use of medication other than 
topical products without significant systemic absorption.
7.
Participation in a clinical research study involving the administration of an 
investigational or marketed drug or device within 30 days prior to the first dosing, 
administration of a biological product in the context of a clinical research study 
within 90 days prior to the first dosing, or concomitant participation in an 
investigational study involving no drug or device administration.
8.
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following 
at least 5 minutes of supine rest. 
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9.
Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may 
affect participant safety or interpretation of study results. 
10. Participants with ANY of the following abnormalities in clinical laboratory tests at 
screening: 

AST or ALT level > ULN;

Total bilirubin level > ULN;

ANC or ALC level > ULN.
Study Arms and Duration:
Study Intervention
Intervention Name
Zavegepant (PF-07930207)
Unit Dose Strength(s)
10 mg 
Route of Administration
Intranasal
Use
Experimental
IMP or NIMP/AxMP
IMP
Study staff will administer the IN spray in one nostril to each participant.
Statistical Methods:
There is no statistical hypothesis for this study, therefore, the study sample size is not based 
on statistical decision rule. The sample size has been chosen based on the need to minimize 
exposure to humans of a new chemical entity and to fulfill the NMPA requirement of
adequate PK data to support zavegepant China registration. A sufficient number of 
participants will be screened to achieve 12 participants enrolled to study intervention. 
Ethical Considerations:
Zavegepant is not expected to provide any clinical benefit to healthy participants. This study 
is designed primarily to generate pharmacokinetic, safety, and tolerability data in healthy 
Chinese adults. Data from this study provide the basis for the clinical development of 
zavegepant as a potential new pharmacological agent for the acute treatment of migraine in 
China.
All study intervention risks are communicated through the IB. Based on the totality of 
available clinical and nonclinical data, and taking into account the measures to monitor and 
minimize risk to study participants, the overall benefit/risk profile supports the clinical 
investigation of zavegepant 10 mg single IN administration in healthy Chinese adults. 
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1.2. Schema
Not applicable.
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1.3. Schedule of Activities
The SoA table provides an overview of the protocol visits and procedures. Refer to the STUDY ASSESSMENTS AND 
PROCEDURES section 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 in the SoA table, in order to conduct evaluations or 
assessments required to protect the well-being of the participant.
Table 1.
Study Schedule of Assessment
Visit Identifier
Abbreviations used in this table may 
be found in Appendix 7.
Screen
Inpatient stay at CRU 
Tele
F/U
Early 
Discont
Notes
Days Relative to Day 1
Day -28 to 
Day -2
Day -1
Day 1
Day 2
Day 28-35

All screening should be done ≤28 days before the 
first dose. 

Follow-up may occur via telephone contact and 
must occur 28-35 days after administration of the 
final dose of study intervention. 
Informed consent
X

Informed consent should be obtained prior to 
undergoing any study-specific procedures. 

See Section 10.1.3 for additional information.
CRU confinement 
X
X
Demography
X
Medical/medication history 
X
X

Medication history will be updated at each visit
Inclusion/exclusion criteria
X
X

See Section 5.1 and Section 5.2.
Review alcohol/caffeine/tobacco
X
X
PE (including height and body 
weight at screening only)
X
X
X

A complete PE may be done at screening or Day -
1; otherwise, brief PE envisioned for findings 
during previous PE or new/open AEs, at the 
investigator discretion. See Section 8.3.1.
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Table 1.
Study Schedule of Assessment
Visit Identifier
Abbreviations used in this table may 
be found in Appendix 7.
Screen
Inpatient stay at CRU 
Tele
F/U
Early 
Discont
Notes
Days Relative to Day 1
Day -28 to 
Day -2
Day -1
Day 1
Day 2
Day 28-35

All screening should be done ≤28 days before the 
first dose. 

Follow-up may occur via telephone contact and 
must occur 28-35 days after administration of the 
final dose of study intervention. 
Nasal inspection
X
X
X 
X
X

The nasal passages and turbinates will be visually 
inspected with a nasal speculum and light at 
screening and Day -1 (to exclude participants 
with mucosal erythema, congestion, septal defects 
etc), prior to dosing, and 24 hours (±30 min) post-
dose to detect evidence of nasal inflammation or 
edema. In addition, participants will be queried 
regarding new nasal symptoms and AEs, which 
will be recorded as appropriate until resolution. 
Vital signs (BP and PR)
X
X
X
X

Supine BP and PR will be performed at 
screening, within 1 hour prior to dosing, and 
approximately 2 hours (±10 min) post-dose.  See 
Section 8.3.3 for details.
12-Lead ECG
X
X
X
X

Supine ECGs will be performed at screening, 
within 1 hour prior to dosing, and approximately 
24 hours (±30 min) post-dose. See Section 8.3.4
for details.
Safety laboratory
X
X
X
X

Screening, Day -1, and 24 hours (±30 min) post-
dose. See Appendix 2 for safety laboratory tests 
in the study. 
Pregnancy test (WOCBP only)
X
X
X
X

A serum pregnancy test is required at screening.
Following screening serum or urine β-hCG for 
female participants of childbearing potential. See 
Section 8.3.7 for details.
Contraception check 
X
X
X
X
FSH
X

For confirmation of postmenopausal status only.
See Section 10.4.3 for the definition of 
postmenopausal. 
Alcohol test, urine cotinine, and 
urine drug testing
X
X
HIV, HBsAg, HCVAb, Syphilis test 
X
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Table 1.
Study Schedule of Assessment
Visit Identifier
Abbreviations used in this table may 
be found in Appendix 7.
Screen
Inpatient stay at CRU 
Tele
F/U
Early 
Discont
Notes
Days Relative to Day 1
Day -28 to 
Day -2
Day -1
Day 1
Day 2
Day 28-35

All screening should be done ≤28 days before the 
first dose. 

Follow-up may occur via telephone contact and 
must occur 28-35 days after administration of the 
final dose of study intervention. 
COVID-19 test(s)
X

The timing and methods of COVID-19 test(s) 
should follow the requirements from local 
regulations or the investigator (CRU).
Study intervention administration
X
PK blood sampling
X
X
X

See Table 2 for details.
CRU discharge 
X

Discharge from CRU after completing protocol 
required activities on the day.
Serious and nonserious AE 
monitoring
X


X
X
X

See Section 8.4.3 for follow-up AE and SAE 
assessments.
Table 2.
PK Sampling Timepoints
Visit Identifier 
Notes
Study Day
Day 1
Day 2
Hour 0 = predose 
sample collection;
The pre-dose blood 
draw will be taken 
within 1 hour before 
dosing. 
See Section 8.5 for 
details of PK 
sample collection.
Minutes/Hours
Before/After Dose
0 
min
5 
min
10 
min
20 
min
30 
min
40 
min
50 
min
1 hr
1.5 hr
2 hr
3 hr
4 hr
8 hr
12 hr
16 hr
24 hr
Study intervention 
administration
X
PK blood sampling 
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
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2. INTRODUCTION
Migraine is a common and debilitating neurological disorder that affects approximately 15% 
of the adult population. It is characterized by moderate-to-severe episodic unilateral pulsating 
headaches that last for 4 to 72 hours. Typical characteristics of the headache are unilateral 
location, pulsating quality, moderate or severe intensity, aggravation by routine physical 
activity, and association with nausea and/or photophobia and phonophobia. Approximately 
half of migraine patients experience nausea or vomiting at the time of migraine onset and 
patients with migraine are also known to have gastroparesis, which can slow absorption of 
oral medications.
Zavegepant (BHV-3500; formerly BMS-742413 or vazegepant) is a selective, high-affinity, 
small molecule CGRP receptor antagonist in development for the treatment of migraine.   
Zavegepant 10 mg intranasal has been developed for the acute treatment of migraine. It 
offers a novel IN CGRP receptor antagonist therapy for the acute treatment of migraine with 
the potential to address important unmet medical needs and optimize speed of efficacy onset 
and an alternate route of administration for patients who suffer from prominent nausea and 
vomiting at the time of migraine onset. Intranasal zavegepant provides ultrarapid onset, 
durable efficacy without the risk of MOH, and without contraindications or warnings 
regarding use by patients with CV disease.
A regional Phase 3 Study (C5301008) is being proposed to evaluate the efficacy and safety 
of zavegepant 10 mg versus placebo in the acute treatment of migraine in Asian (including 
Chinese) adults.
2.1. Study Rationale 
The purpose of the study is to evaluate the PK, safety, and tolerability of zavegepant
following intranasal administration of 10 mg single dose in healthy Chinese adult 
participants. Results from this study will be used to support zavegepant 10 mg IN China 
registration for the acute treatment of migraine.
2.2. Background 
The pharmacology, safety pharmacology, PK, metabolism, toxicology and clinical dose-
ranging efficacy and safety of zavegepant IN administration had been comprehensively 
studied. A summary of relevant, currently available data is provided in this protocol. 
Additional details and further information for this compound could be found in the current 
IB.
2.2.1. Nonclinical Overview
A summary of the nonclinical investigational programs can be found in the current IB.
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2.2.2. Clinical Overview
2.2.2.1. Safety overview
In clinical studies, approximately 2700 participants have been administered zavegepant IN, 
and approximately 606 participants have been administered oral zavegepant. Administration 
of zavegepant was well tolerated at 5 mg, 10 mg, and 20 mg as a single IN spray in 1185 
adult participants with migraine (BHV3500-201). A similar safety profile was observed in 
the 629 adult participants administered a single dose of zavegepant 10 mg IN for the acute 
treatment of migraine (BHV3500-301).
Zavegepant 10 mg IN was well tolerated in a completed long-term safety study (up to 8 doses
per month) in 603 adult participants with migraine for up to 52 weeks (BHV3500-202). The 
most frequently occurring adverse events in clinical studies to date have been associated 
primarily with intranasal administration (eg, dysgeusia, throat irritation, nasal congestion, 
nasal discomfort), as well as nausea and back pain, and the majority have been of mild to 
moderate intensity.
2.2.2.2. Clinical Pharmacology Overview
The clinical pharmacology of IN zavegepant has been well characterized in a comprehensive 
program based on 10 Phase 1 studies. These studies were conducted in approximately 
746 participants including normal healthy participants (N=699), participants in specific 
populations (eg, moderate hepatic impairment; N=8), and participants with migraine (N=39). 
The objective of the clinical pharmacology program was to describe the PK of IN zavegepant 
and identify factors that may affect clinical pharmacology.
Zavegepant is rapidly absorbed (Tmax: 0.54 hr) following a single zavegepant 10 mg IN dose. 
The effective half-life of zavegepant ranged from approximately 5 to 8 hours across dose 
levels ranging from 5 to 40 mg IN. Zavegepant exhibits less than dose proportional increases 
in the exposure following single IN dose administration over the dose range from 1 to 40 mg.
No evidence of meaningful accumulation was observed across a dose range of 5 to 20 mg 
zavegepant IN.
Zavegepant was metabolized by recombinant CYP3A4 and to a lesser extent by recombinant 
CYP2D6 as shown with in vitro assays, although the overall rate of hepatic metabolism of 
zavegepant was very low. Co-administration of 200 mg QD itraconazole with a single dose 
of IN zavegepant 10 mg had no impact on the AUC0-inf of IN zavegepant; zavegepant 
geometric mean Cmax was slightly lowered by approximately 12% but was not deemed to be 
clinically relevant.
The absolute bioavailability of zavegepant was estimated to be 5.12% after a 10 mg IN dose. 
Zavegepant is 89.8% bound (10.2% free) to human plasma proteins and does not 
preferentially distribute into red blood cells. The human IV ADME study demonstrated that 
the primary route of elimination of zavegepant is through biliary elimination, with 84.9% of 
the total radioactivity recovered in feces following a [14C]-zavegepant IV dose compared to 
11.7% recovered in the urine. Exposure to zavegepant accounted for approximately 90% of 
circulating plasma total radioactivity based on AUC0-inf, indicating minimal uncharacterized 
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circulating components in the plasma, which is consistent with the metabolite profiling 
results showing zavegepant comprises 94.85% of the radioprofile in plasma.
The intrinsic factor of hepatic impairment was explored in a dedicated study. In addition, the 
effects of the intrinsic factors such as sex, age, weight, BMI, race, ethnicity, renal and hepatic 
function were defined through PPK modeling. No meaningful impact on zavegepant 
exposures were identified with these covariates with the exception of moderate hepatic 
impairment which showed an approximately 2-fold increase in zavegepant exposure in both 
the dedicated study and from the PPK model. It is recommended that zavegepant dose
frequency be adjusted in moderate hepatic impairment subjects to no more than once every
48 hours. No change in zavegepant dose frequency is recommended in subjects with mild 
hepatic impairment. The impact of severe hepatic impairment has not been studied and 
therefore administration of zavegepant in subjects with severe hepatic impairment is not 
recommended.
Based on the human ADME study, the contribution of renal clearance to zavegepant
elimination is minimal (<12%); additionally, zavegepant has a low metabolic clearance and 
is only moderately (<90%) bound to plasma proteins. Also, based on the PPK analysis, renal 
impairment did not reveal a significant difference in the PK of zavegepant in subjects with 
CrCl ranging from 52 to >90 mL/min. Therefore, changes in renal function are not expected 
to affect the exposure of zavegepant. IN zavegepant may be administered in patients with 
renal impairment without dose adjustment.
2.3. Benefit/Risk Assessment
Zavegepant is not expected to provide any clinical benefit to healthy participants. This study 
is designed primarily to generate pharmacokinetic, safety, and tolerability data in healthy 
Chinese adults. Data from this study provide the basis for the clinical development of 
zavegepant as a potential new pharmacological agent for the acute treatment of migraine in 
China. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of zavegepant may be found in the IB, which is the SRSD for this study.
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2.3.1. Risk Assessment
Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention(s)] 
Not applicable
Not applicable
Not applicable
Study Procedures 
The study intervention will be administered 
intranasally via a liquid spray device.
The intranasal administration could be affected by 
some human and operational factors, such as the  
way of handling the devices and the way of 
inhalation and exhalation. These may lead to 
higher variabilities in PK data.  
Enhance site training and participants education 
in terms of the study intervention administration.
For all the study participants, the study 
intervention administration should be performed 
by no more than 3 study staff to minimize the 
variabilities in device handling. 
Relatively intensive PK sampling and narrow 
time window within 1 hour post dose.  
Risk of PK sample collection outside the required 
time window might be higher.
Enhance site communication and site feasibility 
estimation. 
Actual PK sampling times will be used in the 
derivation of PK parameters.
Other 
The COVID-19 pandemic may pose risks to study 
participation. 
Participants may have increased risk of 
SARS-CoV-2 infection by undergoing a study 
procedure at a study facility.
Inclusion of COVID-19 specific assessments in
the Schedule of Activities as required by local 
regulations or the investigator (CRU).  
Short CRU confinement: 3 days (2 nights). 
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2.3.2. Benefit Assessment
Zavegepant is not expected to provide any clinical benefit to healthy participants. This study 
is designed primarily to generate pharmacokinetic, safety, and tolerability data in healthy 
Chinese adults. Data from this study provide the basis for the clinical development of 
zavegepant as a potential new pharmacological agent for the acute treatment of migraine in 
China. 
2.3.3. Overall Benefit/Risk Conclusion
Taking into account all available nonclinical and clinical data regarding the reassuring safety
and tolerability of zavegepant to date, and measures to monitor and minimize risk to study 
participants, the overall benefit/risk profile supports further clinical development of 
zavegepant in healthy adult Chinese participants.
3. OBJECTIVES AND ENDPOINTS
Objectives
Endpoints
Primary: 
Primary: 

To characterize the systemic exposure of 
zavegepant following IN administration of 
10 mg single dose in healthy Chinese adult 
participants.
Zavegepant plasma PK parameters: Cmax, 
AUClast, and AUCinf, as data permits
Secondary:
Secondary: 

To assess the safety and tolerability of 
zavegepant following IN administration of 
10 mg single dose in healthy Chinese adult 
participants.

To characterize the plasma PK profile of 
zavegepant following IN administration of 
10 mg single dose in healthy Chinese adult 
participants.

AEs, clinical safety laboratory tests, vital 
signs (BP and PR), physical examinations, and 
12-lead ECGs.

Additional zavegepant plasma PK parameters: 
Tmax, t½, CL/F and Vz/F, as data permits
4. STUDY DESIGN
4.1. Overall Design
This is a Phase 1, open-label, single dose study to characterize the PK, safety and tolerability 
of zavegepant in healthy Chinese adults following a single intranasal dose of 10 mg. 
Approximately 12 eligible participants, ages of 18 to 55 years (inclusive), will be enrolled in 
the study.
Screening evaluation will occur within 28 days prior to the study intervention administration 
(Day 1). Participants will be admitted to the CRU the day before Day 1 and will be kept 
under safety monitoring for 2 days at the CRU. Participants will receive 10 mg single dose of 
IN zavegepant on Day 1. The PK of zavegepant will be characterized following Day 1 
dosing. A telephone follow-up will be made 28-35 days after the single dose. 
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This study will be conducted in a single center in China. 
In this study, if more than 2 participants prematurely discontinue for reasons unrelated to the 
safety of the investigational product, participants may be replaced, at the discretion of the PI 
and sponsor study team.
4.2. Scientific Rationale for Study Design
Zavegepant is being developed for the acute treatment of migraine via the IN route. 
The clinical pharmacology of IN zavegepant has been well characterized in a comprehensive 
program based on 10 Phase 1 studies oversea. There should be no expected significant PK 
difference between different races based on the totality of oversea data. This study is the first 
China standalone Phase 1 study with zavegepant in healthy Chinese population. 
The objectives of this Phase 1 is to characterize the PK, safety and tolerability of zavegepant 
in healthy Chinese adults. Results from this study will be used to support the ethnic 
difference/similarity analysis between Chinese and non-Chinese, and to support zavegepant 
China registration.
The effect of sex was evaluated in the PPK analysis of zavegepant. After adjusting for the 
effects of body weight, females were found to have no meaningful change (<20%) in 
clearance or volume of distribution as compared to males when administered zavegepant 
10 mg, IN. No special labeling guidance with respect to dosage and administration is needed 
for sex. Therefore, male and/or female Chinese participants will be enrolled in this study.
Although no evidence of embryolethality and teratogenicity were found in animal 
embryofetal development studies in rats and rabbits with zavegepant, women of childbearing 
potential (WOCBP) are recommended to use effective methods of contraception before and 
during exposure to zavegepant in order to prevent pregnancy. No data are available on the
potential in vivo transfer of zavegepant or its metabolites into human breast milk. Therefore, 
non-pregnant, non-lactating females will be included in the study and any female of 
childbearing potential will be included if they use appropriate methods of contraception (See 
Appendix 4).
The potential risk of exposure to zavegepant in a sexual partner of a male participant in this 
study via ejaculate is low, and therefore no contraception (condom) use in male participants 
is warranted. The calculated safety margin is ≥100-fold between the estimated partner 
exposure due to seminal transfer and the NOAEL for serious manifestations of 
developmental toxicity in nonclinical studies. The safety margin of 100-fold is based on 
applying a 10-fold safety factor for interspecies extrapolation and a 10-fold safety factor for 
susceptible populations.1
4.3. Justification for Dose
The intranasal dose of 10 mg has been carried forward as the therapeutic dose for acute 
treatment of migraine based on the clinically significant efficacy and acceptable safety 
profile observed with zavegepant. A regional Phase 3 Study (C5301008) is being proposed to 
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evaluate the efficacy and safety of zavegepant 10 mg versus placebo in the acute treatment of 
migraine in Asian (including Chinese) adults. Results from these studies (C5301009 and 
C5301008) will be used to support Zavegepant 10 mg IN China registration for the acute 
treatment of migraine. 
4.4. End of Study Definition
The end of the study is defined as the date of the last visit of the last participant in the study.
A participant is considered to have completed the study if they have completed all visits of 
the study, including the last scheduled procedure shown in the SoA. Follow-up visits in 
addition to those in the SoA may be scheduled at investigator discretion, including to monitor 
open AE, or based on emerging data.
5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled. A
prescreening tool may be utilized for study recruitment purposes, it will include collection of 
information that reflects the enrollment of population including, where permitted under local 
regulations, age, sex, and ethnicity. The following eligibility criteria are designed to select 
participants 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 participant is suitable for this protocol.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
1. Male or female Chinese participants, between the ages of 18 and 55 years, inclusive,
at the time of signing the ICD. 

Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and 
female (Section 10.4.2) participants.

Chinese participants are defined as individuals currently residing in mainland 
China who were born in China and have both parents of Chinese descent.
Other Inclusion Criteria:
2. Male and female Chinese participants who are overtly healthy as defined by:

the absence of clinically significant illness and surgery within 4 weeks prior to 
dosing. Participants vomiting within 24 hours predose will be carefully evaluated 
for upcoming illness/disease.
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
the absence of clinically significant history of neurological, endocrinal, 
cardiovascular, pulmonary, hematological (eg, neutropenia), immunologic, 
psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
3. BMI of 18.0 to 30.0 kg/m2; and a total body weight ≥50.0 kg (110 lb) for males and 
≥45.0 kg (99 lb) for females. 
4. Non-smoker (no use of tobacco or nicotine products within 3 months prior to 
screening).
5. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the ICD and in 
this protocol.
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. Evidence or history of clinically significant hematological, renal, endocrine, 
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or 
allergic disease (including drug allergies, but excluding untreated, asymptomatic, 
seasonal allergies at the time of dosing).

Current diagnosis of viral hepatitis or a history of liver disease.

History of HIV infection, syphilis, hepatitis B, or hepatitis C; positive testing for 
HIV, syphilis, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
2.
Significant history of seizure disorder other than a single childhood febrile seizure 
(eg, epilepsy).
3.
Clinically significant history of nasal conditions that may affect the administration 
or absorption of the nasal product (eg, severe septum deviation or nasal deformity, 
inflammation, perforation, mucosal erosion, localized infection or ulceration, 
congestion, polyposis, rhinorrhea, nasal surgery, or nasal trauma).
4.
History of gallstone or cholecystectomy. 
5.
Other medical or psychiatric condition including recent (within the past year) or 
active suicidal ideation/behavior or laboratory abnormality or other conditions or 
situations related to COVID-19 pandemic that may increase the risk of study 
participation or, in the investigator’s judgment, make the participant inappropriate 
for the study.
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Prior/Concomitant Therapy:
6.
Refer to Section 6.9 Prior and Concomitant Therapy. Use of medication other than 
topical products without significant systemic absorption

Prescription medication within 14 days or 5 half-lives (whichever is longer) prior 
to the first dosing (hormonal contraception allowed);

Over-the-counter products and natural health products (including acetaminophen-
containing products, all intranasal spray medications/saline, herbal remedies such 
as Butterbur root or extracts, homeopathic and traditional medicines, probiotics, 
food supplements such as vitamins, minerals, amino acids, essential fatty acids, 
and protein supplements used in sports) within 7 days or 5 half-lives (whichever 
is longer) prior to the first dosing, with the exception of the occasional use of 
ibuprofen;

A depot injection or an implant of any drug within 6 months prior to the first 
dosing;

Small molecule CGRP receptor antagonists within 1 month prior to dosing;

Biologic CGRP receptor antagonist within 6 months prior to dosing;

Oxymetazoline (or other nasal spray decongestants) from at least 14 days prior to 
the first dosing;

Receipt of any vaccination, including COVID-19 vaccine, within 14 days prior to 
first dosing.
Prior/Concurrent Clinical Study Experience:
7.
Participation in a clinical research study involving the administration of an 
investigational or marketed drug or device within 30 days prior to the first dosing, 
administration of a biological product in the context of a clinical research study 
within 90 days prior to the first dosing, or concomitant participation in an 
investigational study involving no drug or device administration.
Diagnostic Assessments:
8.
Any clinically significant abnormal laboratory test results or positive test found 
during medical screening.
9.
Evidence of organ dysfunction or any clinically significant deviation from normal 
in physical examination, nasal inspection, vital signs, 12-lead ECG, or clinical 
laboratory determinations beyond what is consistent with the target population.
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10. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following 
at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg 
(diastolic), the BP should be repeated 2 more times and the average of the 3 BP 
values should be used to determine the participant’s eligibility.
11. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may 
affect participant safety or interpretation of study results (eg, QTcF >450 ms, 
complete LBBB, signs of an acute or indeterminate- age myocardial infarction, 
ST-T interval changes suggestive of myocardial ischemia, second- or third- degree 
AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT 
interval is >450 ms, this interval should be rate-corrected using the Fridericia 
method only and the resulting QTcF should be used for decision making and 
reporting. If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be 
repeated twice and the average of the 3 QTcF or QRS values used to determine the 
participant’s eligibility. Computer-interpreted ECGs should be overread by a 
physician experienced in reading ECGs before excluding a participant.
12. Participants 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 test, if deemed necessary: 

AST or ALT level > ULN; Only abnormal values between 1-1.5 × ULN may 
be repeated once for confirmation to below ULN.

Total bilirubin level > ULN; participants with a history of Gilbert’s syndrome 
may have direct bilirubin measured and would be eligible for this study 
provided the direct bilirubin level is ≤ULN.

ANC or ALC level > ULN.
13. Positive urine drug screen, alcohol breath test, or urine cotinine test at screening or 
baseline.
14. Positive pregnancy test at screening or baseline (Day -1).
15. Positive result for COVID-19 at the time of Screening and admission.
Other Exclusion Criteria:
16. History of significant alcohol abuse within 6 months prior to screening or regular 
use of alcohol within 6 months prior to the screening visit (more than fourteen units 
of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% 
alcohol]).
17. History of significant drug abuse within 6 months prior to screening or use of soft 
drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs 
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(such as cocaine, PCP, crack, opioid derivatives including heroin, and 
amphetamine derivatives) within 1 year prior to screening.
18. History of anaphylaxis reaction, a documented hypersensitivity reaction, or a 
clinically important reaction to any drug.
19. Donation of plasma within 30 days prior to dosing. Donation or loss of blood 
(excluding volume drawn at screening) of approximately 400 mL or more within 
60 days prior to dosing.
20. Presence of piercings or any physical findings in the nose that, in the opinion of the 
PI, would be likely to interfere with successful completion of the dosing procedure.
21. Inability to be venipunctured and/or tolerate catheter venous access.
22. Habitual use of snuff tobacco.
23. Any reason which, in the opinion of the PI, would prevent the participant from 
participating in the study.
24. History of sensitivity to heparin or heparin-induced thrombocytopenia.
25. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.
26. Investigator site staff directly involved in the conduct of the study and their family 
members, site staff otherwise supervised by the investigator, and sponsor and 
sponsor delegate employees directly involved in the conduct of the study and their 
family members.
5.3. Lifestyle Considerations
The following guidelines are provided:
5.3.1. Contraception
In female participants of child-bearing potential, the investigator or their designee, in 
consultation with the participant, will confirm that the participant is utilizing an appropriate 
method of contraception for the individual participant from the permitted list of contraception 
methods (see Appendix 4, Section 10.4.4) and will confirm that the participant has been 
instructed in its consistent and correct use. At time points indicated in SoA, the investigator 
or designee will inform the participant of the need to use acceptable effective contraception 
consistently and correctly and document the conversation and the participant’s affirmation in 
the participant’s chart. Participants need to affirm their consistent and correct use of at least 1 
of the selected methods of contraception, considering that their risk for pregnancy may have 
changed since the last visit. 
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In addition, the investigator or designee will instruct the participant to call immediately if the 
selected contraception method is discontinued and document the requirement to use an 
alternate protocol-specified method, including if the participant will no longer use abstinence 
as the selected contraception method, or if pregnancy is known or suspected in the participant 
or partner.
5.3.2. Meals and Dietary Restrictions

Participants must abstain from all food and drink (except water) at least 4 hours 
prior to any safety laboratory evaluations.

Participants will refrain from consuming red wine, grapefruit, or grapefruit-related 
citrus fruits (eg, Seville oranges, pomelos, fruit juices) from 7 days prior to the first 
dose of study intervention until collection of the final PK blood sample. 

Food or beverages containing xanthine derivatives or xanthine-related compounds 
or energy drinks from 48 hours prior to dosing until after the last PK blood sample 
collection .
5.3.3. Caffeine, Alcohol, and Tobacco

Participants will abstain from caffeine-containing products for 24 hours prior to the 
start of dosing until collection of the final PK sample. 

Participants will abstain from alcohol for 24 hours prior or as specified above for 
red wine to admission to the CRU and continue abstaining from alcohol until 
collection of the final PK sample. Participants may undergo an alcohol breath test 
or blood alcohol test at the discretion of the investigator.

Participants will abstain from the use of tobacco- or nicotine-containing products 
for 24 hours prior to dosing and during confinement in the CRU. 
5.3.4. Activity

Participants 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.
5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently enrolled in the study. Screen failure data are collected and remain as 
source and are not reported on the CRF.
Individuals who do not meet the criteria for participation in this study (screen failure) may 
not be rescreened. 
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6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY
Study interventions are all prespecified investigational, noninvestigational medicinal 
products, medical devices, and other interventions (eg, surgical and behavioral) intended to 
be administered to the study participants during the study conduct. For the purposes of this 
protocol, study intervention refers to zavegepant.
6.1. Study Intervention(s) Administered
Zavegepant (PF-07930207) is formulated as 10 mg for intranasal single dose administration. 
The study intervention will be provided in single use unidose nasal spray devices fully 
prepared and ready for administration.
Study Intervention
Intervention Name
Zavegepant (PF-07930207)
Arm Name
Single Arm
Type
Drug
Dose Formulation
Nasal spray
Unit Dose Strength(s)
10 mg
Dosage Level(s)
Single dose
Route of Administration
Intranasal
Use
Experimental
IMP or NIMP/AxMP
IMP
Sourcing
Provided centrally by the sponsor 
Refer to the IP manual.
Packaging and Labeling
Study intervention will be provided in unidose nasal spray. 
Each spray will be labeled as required per country 
requirement.
Current/Former Name(s) or Alias(es)
Zavegepant (PF-07930207)
6.1.1. Administration
Following an overnight fast of at least 10 hours, participants will receive study intervention
at approximately 0800 hours (plus or minus 2 hours). Investigator site personal will 
administer study intervention according to the IPM.
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Study staff will administer the IN spray in one nostril to each participant. After the dose is 
administered, participants will be asked to remain seated upright for approximately 
10 minutes in order to avoid any study intervention leakage. Participants must not blow their 
nose for 2 hours after dosing and will be requested to gently sniff up any nasal drip. 
Participants must inform the staff if they sneeze or if the product drips out of their nose.
Participants must inform the study staff if they believe the device did not function properly, 
ie, if they believe the device did not dispense a spray. All occurrences of dose 
misadministration or unidose nasal spray malfunction should be communicated to the 
sponsor as soon as possible.
Under no circumstance may a participant be administered a supplementary dose of study 
medication.
6.2. Preparation, Handling, Storage, and Accountability
1. The investigator or designee must confirm that appropriate conditions (eg, 
temperature) have been maintained during transit for all study interventions
received and any discrepancies are reported and resolved before use of the study 
intervention. 
2. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply, prepare, and/or administer study intervention.
3. All study interventions must be stored in a secure, environmentally controlled, and 
monitored (manual or automated recording) area in accordance with the labeled 
storage conditions with access limited to the investigator and authorized site staff. 
At a minimum, daily minimum and maximum temperatures for all site storage 
locations must be documented and available upon request. Data for nonworking 
days must indicate the minimum and maximum temperatures since previously 
documented upon return to business.
4. Any excursions from the study intervention label storage conditions should be 
reported to Pfizer upon discovery along with actions taken. The site should actively 
pursue options for returning the study intervention to the labeled storage 
conditions, as soon as possible. Once an excursion is identified, the study 
intervention must be quarantined and not used until Pfizer provides permission to 
use the study intervention. Specific details regarding the excursion definition and 
information to report for each excursion will be provided to the site in the IPM.
5. Any storage conditions stated in the SRSD will be superseded by the storage 
conditions stated on the label.
6. Study interventions should be stored in their original containers.
7. The investigator, institution, head of the medical institution (where applicable), or 
authorized site staff is responsible for study intervention accountability, 
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reconciliation, and record maintenance (ie, receipt, reconciliation, and final 
disposition records), such as the IPAL or sponsor-approved equivalent. All study 
interventions will be accounted for using a study intervention accountability 
form/record.
8. Further guidance and information for the final disposition of unused study 
interventions are provided in the IPM. All destruction must be adequately 
documented. If destruction is authorized to take place at the investigator 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.
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IPM.
6.2.1. Preparation and Dispensing
Within this protocol, preparation refers to the investigator site activities performed to make 
the study intervention ready for administration or dispensing to the participant by qualified 
staff. Dispensing is defined as the provision of study intervention, concomitant treatments, 
and accompanying information by qualified staff member(s) to a healthcare provider, 
participant, in accordance with this protocol. Local health authority regulations or 
investigator site guidelines may use alternative terms for these activities.
Zavegepant will be handled and prepared according to the IPM that will be provided to the 
site. Study intervention should be prepared and dispensed by an appropriately qualified and 
experienced member of the study staff (eg, physician, nurse, physician’s assistant, nurse 
practitioner, pharmacy assistant/technician, or pharmacist) as allowed by local, state, and 
institutional guidance. A second staff member will verify the dispensing.
All spray devices will be presented as single-use devices.
6.3. Assignment to Study Intervention
This is an open-label study. No randomization or blinding mechanisms will be used. The 
investigator’s knowledge of the treatment should not influence the decision to enroll a 
particular participant or affect the order in which participants are enrolled.
The investigator will assign participant numbers to the participants as they are screened for 
the study. Pfizer will provide an allocation schedule to the investigator. The participant will 
receive the study intervention in compliance with the SoA and the protocol instruction.
6.4. Blinding
This is an open-label study. 
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6.5. Study Intervention Compliance
When participants are dosed at the site, they will receive study intervention directly from the 
investigator or designee, under medical supervision. The date and time of the dose 
administered in the clinic will be recorded in the source documents and recorded in the CRF. 
The dose of study intervention and study participant identification will be confirmed at the 
time of dosing by a member of the study site staff other than the person administering the 
study intervention.
6.6. Dose Modification
By design, this study only includes administration of single, IN dose of zavegepant at fixed 
dosage level (10 mg). As such, dose modifications will not be made during the study.
6.7. Continued Access to Study Intervention After the End of the Study
No study intervention will be provided to participants at the end of their study participation.
6.8. Treatment of Overdose
There is no clinical experience with overdose of zavegepant. This is a single and fixed dose 
study. For this study, any dose of zavegepant greater than 40 mg (the maximum dose has 
been explored to-date) within a 24-hour time period will be considered an overdose.
There is no specific treatment for an overdose.
In the event of an overdose, the investigator should:
1. Contact the study medical monitor within 24 hours.
2. Closely monitor the participant for any AEs/SAEs and laboratory abnormalities as 
medically appropriate and at least until the next scheduled follow-up.
3. Document the quantity of the excess dose as well as the onset time of the overdose in 
the CRF.
4. Overdose is reportable to Pfizer Safety only when associated with an SAE.
5. Obtain a blood sample for PK analysis within 2 hours from the last dose of study 
intervention if requested by the study medical monitor (determined on a 
case-by-case basis).
6.9. Prior and Concomitant Therapy
Use of prescription or nonprescription drugs and dietary and herbal supplements for the 
timeframes specified below and throughout the study are prohibited. Limited use of 
nonprescription medications that are not believed to affect participant safety or the PK profile 
of the study intervention may be permitted on a case-by-case basis following approval by the 
sponsor.
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Main study restrictions include:

Biologic CGRP receptor antagonist within 6 months prior to the first dosing until 
after the last PK blood sample collection of the study;

A depot injection or an implant of any drug within 6 months prior to the first dosing 
until after the last PK blood sample collection of the study;

Small molecule CGRP receptor antagonists within 1 month prior to the first dosing 
until after the last PK blood sample collection of the study;

Oxymetazoline (or other nasal spray decongestants) from at least 14 days prior to 
the first dosing until after the last PK blood sample collection of the study;

Prescription medication within 14 days or 5 half-lives (whichever is longer) prior to 
the first dosing until after the last PK blood sample collection of the study
(hormonal contraception allowed);

OTC products (including acetaminophen-containing products, all intranasal spray
medications/saline) within 7 days or 5 half-lives (whichever is longer) prior to the 
first dosing until after the last PK blood sample collection of the study, with the 
exception of the occasional use of ibuprofen;

Natural health products (including herbal remedies such as Butterbur root or 
extracts, homeopathic and traditional medicines, probiotics, food supplements such 
as vitamins, minerals, amino acids, essential fatty acids, and protein supplements 
used in sports) within 7 days or 5 half-lives (whichever is longer) prior to the first 
dosing until after the last PK blood sample collection of the study;

Receipt of any vaccination, including COVID-19 vaccine, within 14 days prior to 
first dosing.
Hormonal contraceptives that meet the requirements of this study are allowed to be used in 
participants who are WOCBP (see Appendix 4).
All concomitant treatments taken during the study must be recorded with indication, daily 
dose, and start and stop dates of administration. All participants will be questioned about 
concomitant treatment at each clinic visit.
Treatments taken within 28 days before the first dose of study intervention will be 
documented as a prior treatment. Treatments taken after the first dose of study intervention 
will be documented as concomitant treatments.
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
Since this is a single dose study, this section is not applicable.
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7.2. Participant Discontinuation/Withdrawal From the Study
A participant may withdraw from the study at any time at their own request. Reasons for 
discontinuation from the study include the following:

Refused further study procedures;

Lost to follow-up;

Safety reason;

Death;

Study terminated by sponsor.
At the time of discontinuing from the study, if possible, an early discontinuation visit should 
be conducted. See the SoA for assessments to be collected at the time of study 
discontinuation and follow-up and for any further evaluations that need to be completed. 
The early discontinuation visit applies only to participants who are enrolled/randomized and 
then are prematurely withdrawn from the study. Participants should be questioned regarding 
their reason for withdrawal.
The participant will be permanently discontinued from the study intervention and the study at 
that time.
If a participant withdraws from the study, they may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly.
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations will be performed and no 
additional data will be collected. The sponsor may retain and continue to use any data 
collected before such withdrawal of consent.
7.2.1. Withdrawal of Consent 
Participants who request to discontinue receipt of study intervention 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 participant specifically withdraws consent for any further contact 
with them or persons previously authorized by the participant to provide this information. 
Participants 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 study intervention or also from study procedures and/or posttreatment study 
follow-up, and entered on the appropriate CRF page. In the event that vital status (whether 
the participant 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.
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7.3. Lost to Follow-up 
A participant will be considered lost to follow-up if the participant repeatedly fails to return 
for scheduled visits or is unable to be contacted by the study site.
The following actions must be taken before a participant is deemed lost to follow-up :
The site must attempt to contact the participant and reschedule the missed visit as
soon as possible. Counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether the participant wishes to and/or 
should continue in the study;
Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 
3 telephone calls and, if necessary, a certified letter to the participant’s last known 
mailing address or local equivalent methods). These contact attempts should be 
documented in the participant’s medical record;
Should the participant continue to be unreachable, the participant will be considered 
to have withdrawn from the study. 
8. STUDY ASSESSMENTS AND PROCEDURES
8.1. Administrative Procedures
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures.  
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed.
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct.
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
Participants will be screened within 28 days prior to administration of the study intervention 
to confirm that they meet the study population criteria for the study. If the time between 
screening and dosing exceeds 28 days as a result of unexpected delays (eg, delayed drug 
shipment), then participants do not require rescreening if the laboratory results obtained prior 
to first dose administration meet eligibility criteria.
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 make it unfeasible to perform the 
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test. In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant. When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that they have 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.
If an IV catheter is utilized for blood sample collections, ECGs and vital sign assessments 
(pulse rate and BP) should be collected prior to the insertion of the catheter.
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.
The total blood sampling volume for individual participants for PK assessment in this study 
is approximately 48 mL. The other blood sampling for safety or other assessments should be 
collected according to the SoA, and the actual volume will depend on the clinical practice in 
the CRU. The total blood sampling volume for individual participants in this study will be 
described in the informed consent. The actual collection times and volumes of blood 
sampling may change. 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 56 consecutive days.
To prepare for study participation, participants will be instructed on the information in the 
Lifestyle Considerations and Concomitant Therapy sections of the protocol.
8.2. Efficacy Assessments
Not Applicable.
8.3. Safety Assessments
Planned time points for all safety assessments are provided in the SoA. Unscheduled safety
measurements may be obtained at any time during the study to assess any perceived safety 
issues.
8.3.1. Physical Examinations
A complete physical examination will include, at a minimum, head, ears, eyes, nose, mouth, 
skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and 
neurological systems. 
A brief physical examination will include, at a minimum, assessments of general appearance, 
the respiratory and cardiovascular systems, and participant-reported symptoms.
Physical examinations may be conducted by a physician, trained physician’s assistant, or 
nurse practitioner as acceptable according to local regulation. 
Height and weight will also be measured and recorded as per the SoA. For measuring weight, 
a scale with appropriate range and resolution is used and must be placed on a stable, flat 
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surface. Participants 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. 
Physical examination findings collected during the study will be considered source data and 
will not be required to be reported, unless otherwise noted. Any untoward physical 
examination findings that are identified during the active collection period and meet the 
definition of an AE or SAE (Appendix 3) must be reported according to the processes in 
Sections 8.4.1 to 8.4.3.
8.3.2. Nasal Inspection
The nasal passages and turbinates will be visually inspected with a nasal speculum and light
at screening and Day -1 (to exclude participants with mucosal erythema, congestion, septal 
defects etc), prior to dosing, and 24 hours (±30 min) post-dose to detect evidence of nasal 
inflammation or edema. In addition, participants will be queried regarding new nasal 
symptoms and AEs, which will be recorded as appropriate until resolution.
8.3.3. Vital Signs
8.3.3.1. Blood Pressure and Pulse Rate
Supine BP will be measured with the participant’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. Participants should be 
instructed not to speak during measurements. 
The same properly sized and calibrated BP cuff will be used to measure BP each time. The 
use of an automated device for measuring BP and pulse rate is acceptable; however, 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, BP 
and pulse rate should be obtained prior to the nominal time of the blood collection.
Additional collection times, or changes to collection times, of BP and pulse rate will be 
permitted, as necessary, to ensure appropriate collection of safety data.
Any untoward vital sign findings that are identified during the active collection period and 
meet the definition of an AE or SAE (Appendix 3) must be reported according to the 
processes in Sections 8.4.1 to 8.4.3.
8.3.4. Electrocardiograms
Standard 12-lead ECGs utilizing limb leads (with a 10-second rhythm strip) should be 
collected at times specified in the SoA section of this protocol using an ECG machine that 
automatically calculates the HR and measures PR interval, QT interval, QTcF, and QRS 
complex. Alternative lead placement methodology using torso leads (eg, Mason-Likar) 
should not be used given the potential risk of discrepancies with ECGs acquired using 
standard limb lead placement. All scheduled ECGs should be performed after the participant
has rested quietly for at least 5 minutes in a supine position.
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To ensure safety of the participants, a qualified individual at the investigator site will make 
comparisons to baseline measurements. Additional ECG monitoring will occur if a) a 
postdose QTcF interval is increased by ≥60 ms from the baseline and is >450 ms; or b) an 
absolute QT value is ≥500 ms for any scheduled ECG. If either of these conditions occurs, 
then 2 additional ECGs will be collected approximately 2 to 4 minutes apart to confirm the 
original measurement. If the QTcF values from these repeated ECGs remain above the 
threshold value, 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 a) a postdose QTcF interval remains ≥60 ms from the baseline and is >450 ms; or b) an 
absolute QT value is ≥500 ms for any scheduled ECG for greater than 4 hours (or sooner, at 
the discretion of the investigator); or c) QTcF value get progressively longer, the participant
should undergo continuous ECG monitoring. A cardiologist should be consulted if QTcF
values do not return to less than the criteria listed above 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 be 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 medical provider’s interpretation determines that the QTcF values are in the 
acceptable range.
ECG values of potential clinical concern are listed in Appendix 6.
8.3.5. Clinical Safety Laboratory Assessments
See Appendix 2 for the list of clinical safety laboratory tests to be performed and the SoA for 
the timing and frequency. All protocol-required laboratory assessments, as defined in 
Appendix 2, must be conducted in accordance with the laboratory manual and the SoA. 
Unscheduled clinical laboratory measurements may be obtained at any time during the study 
to assess any perceived safety issues.  
The investigator must review the laboratory report, document this review, and record any 
clinically significant changes occurring during the study in the AE section of the CRF. 
Clinically significant abnormal laboratory test findings are those that are not associated with 
the underlying disease, unless judged by the investigator to be more severe than expected for 
the participant’s condition.
All laboratory tests with values considered clinically significant and abnormal during 
participation in the study or within 2 days after the last dose of study intervention should be 
repeated until the values return to normal or baseline or are no longer considered clinically 
significant by the investigator or study medical monitor.
If such values do not return to normal/baseline within a period of time judged reasonable by 
the investigator, the etiology should be identified and the sponsor notified.
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See Appendix 5 for suggested actions and follow-up assessments in the event of potential 
DILI.
8.3.6. COVID-19 Specific Assessments
Participants will be tested for COVID-19 infection prior to being admitted to the clinic for 
confinement or site visit in compliance with the requirements from local regulations or the
investigator. Additional testing for COVID-19 (eg, chest radiograph) may be required by 
local regulations or by the investigator.
8.3.7. Pregnancy Testing
A serum pregnancy test is required at screening. Following screening, pregnancy tests may 
be urine or serum tests, and must have a sensitivity of at least 25 mIU/mL. Pregnancy tests 
will be performed in WOCBP at the times listed in the SoA. Following a negative pregnancy 
test result at screening, appropriate contraception must be commenced and a second negative 
pregnancy test result will be required at the baseline visit prior to the participant’s receiving 
the study intervention. Pregnancy tests will also be done whenever 1 menstrual cycle is 
missed during the active treatment period (or when potential pregnancy is otherwise 
suspected) and at the end of the study. Pregnancy tests may also be repeated if requested by 
IRBs/ECs or if required by local regulations.
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting
The definitions of an AE and an SAE can be found in Appendix 3.
AEs may arise from symptoms or other complaints reported to the investigator by the 
participant (or, when appropriate, by a caregiver, surrogate, or the participant’s legally 
authorized representative), or they may arise from clinical findings of the investigator or 
other healthcare providers (clinical signs, test results, etc).
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study (see Section 7.1). 
During the active collection period as described in Section 8.4.1, each participant will be 
questioned about the occurrence of AEs in a nonleading manner.
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion.
8.4.1. Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before undergoing any study-related procedure and/or receiving study 
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intervention), through and including a minimum of 28 calendar days, except as indicated 
below, after the last administration of the study intervention.
Follow-up by the investigator continues throughout the active collection period and until the 
AE or SAE or its sequelae resolve or stabilize at a level acceptable to the investigator.
When a clinically important AE remains ongoing at the end of the active collection period, 
follow-up by the investigator continues until the AE or SAE or its sequelae resolve or 
stabilize at a level acceptable to the investigator and Pfizer concurs with that assessment.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant permanently discontinues or temporarily discontinues study because of an AE 
or SAE, the AE or SAE must be recorded on the CRF and the SAE reported using the CT 
SAE Report Form.
Investigators are not obligated to actively seek information on AEs or SAEs after the 
participant has concluded study participation. However, if the investigator learns of any SAE, 
including a death, at any time after a participant has completed the study, and they consider 
the event to be reasonably related to the study intervention, the investigator must promptly 
report the SAE to Pfizer using the CT SAE Report Form.
8.4.1.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period as described in 
Section 8.4.1 are reported to Pfizer Safety on the CT SAE Report Form immediately upon 
awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 3. The investigator will submit any updated SAE data to the sponsor within 
24 hours of its being available.
8.4.1.2. Recording Nonserious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.4.1, will be recorded 
on the AE section of the CRF.
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant.
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 an 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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Reporting of AEs and SAEs for participants who fail screening are subject to the CRF 
requirements as described in Section 5.4.
8.4.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.4.3. Follow-Up of AEs and SAEs
After the initial AE or SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality. Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided. In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is provided in Appendix 3.
8.4.4. Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, IRBs/ECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary.
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements.
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8.4.5. Environmental Exposure, Exposure During Pregnancy or Breastfeeding, and 
Occupational Exposure
Environmental exposure, occurs when a person not enrolled in the study as a participant 
receives unplanned direct contact with or exposure to the study intervention. Such exposure 
may or may not lead to the occurrence of an AE or SAE. Persons at risk for environmental 
exposure include healthcare providers, family members, and others who may be exposed. An 
environmental exposure may include EDP, EDB, and occupational exposure.
Any such exposures to the study intervention under study are reportable to Pfizer Safety 
within 24 hours of investigator awareness.
8.4.5.1. Exposure During Pregnancy
An EDP occurs if: 
A female participant is found to be pregnant while receiving or after discontinuing 
study intervention.
A male participant who is receiving or has discontinued study intervention
inseminates a female partner. 
A female nonparticipant is found to be pregnant while being exposed or having been 
exposed to study intervention because of environmental exposure. Below are 
examples of environmental EDP:  
A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by inhalation or skin contact.
A male family member or healthcare provider who has been exposed to the study 
intervention by inhalation, or skin contact then inseminates his female partner 
prior to or around the time of conception.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy). 
If EDP occurs in a participant/participant’s partner, the investigator must report this 
information to Pfizer Safety on the CT SAE Report Form and an EDP 
Supplemental Form, regardless of whether an SAE has occurred. Details of the 
pregnancy will be collected after the start of study intervention and until 28 days
after the last dose.
If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the CT SAE Report Form and EDP 
Supplemental Form. Since the exposure information does not pertain to the 
participant enrolled in the study, the information is not recorded on a CRF; 
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however, a copy of the completed CT SAE Report Form is maintained in the 
investigator site file.
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 Safety 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).
Abnormal pregnancy outcomes are considered SAEs. 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 to 
Pfizer Safety as SAEs follows: 
Spontaneous abortion including miscarriage and missed abortion should be reported 
as an SAE;
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 study intervention. 
Additional information regarding the EDP may be requested by the sponsor. 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 participant with the Pregnant Partner Release of Information 
Form to deliver to his partner. The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner.
8.4.5.2. Exposure During Breastfeeding
An EDB occurs if:
A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention.
A female nonparticipant is found to be breastfeeding while being exposed or having 
been exposed to study intervention (ie, environmental exposure). An example of 
environmental EDB is a female family member or healthcare provider who reports 
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that she is breastfeeding after having been exposed to the study intervention by 
inhalation or skin contact.  
The investigator must report EDB to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The information must be reported 
using the CT SAE Report Form. When EDB occurs in the setting of environmental exposure, 
the exposure information does not pertain to the participant enrolled in the study, so the 
information is not recorded on a CRF. However, a copy of the completed CT SAE Report 
Form is maintained in the investigator site file.
An EDB report is not created when a Pfizer drug specifically approved for use in 
breastfeeding women (eg, vitamins) is administered in accordance with authorized use. 
However, if the infant experiences an SAE associated with such a drug, the SAE is reported 
together with the EDB.
8.4.5.3. Occupational Exposure
The investigator must report any instance of occupational exposure to Pfizer Safety within 24 
hours of the investigator’s awareness using the CT SAE Report Form regardless of whether 
there is an associated SAE. Since the information about the occupational exposure does not 
pertain to a participant enrolled in the study, the information is not recorded on a CRF; 
however, a copy of the completed CT SAE Report Form must be maintained in the 
investigator site file.
8.4.6. Cardiovascular and Death Events
Not applicable. 
8.4.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable.
8.4.8. Adverse Events of Special Interest
Not applicable.
8.4.8.1. Lack of Efficacy
This section is not applicable because efficacy is not expected in the study population.
8.4.9. Medical Device Deficiencies
Not applicable.
8.4.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
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Medication errors are recorded and reported as follows:
Recorded on the 
Medication Error Page 
of the CRF
Recorded on the 
Adverse Event Page 
of the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness
All (regardless of whether 
associated with an AE)
Any AE or SAE associated 
with the medication error
Only if associated with an 
SAE
Medication errors include:

Medication errors involving participant exposure to the study intervention;

Potential medication errors or uses outside of what is foreseen in the protocol that 
do or do not involve the study participant.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF.
In the event of a medication dosing error, the sponsor should be notified within 24 hours.
Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE.
8.5. Pharmacokinetics 
Blood samples of approximately 3 mL, to provide approximately 1.2 mL plasma, will be 
collected for measurement of plasma concentrations of zavegepant as specified in the SoA. 
Instructions for the collection and handling of biological samples will be provided in the 
laboratory manual or by the sponsor. The actual date and time (24-hour clock time) of each 
sample will be recorded.
The actual times may change, but the number of samples will remain the same. All efforts 
will be made to obtain the samples at the exact nominal time relative to dosing. Collection of 
samples up to and including 10 hours after dose administration that are obtained within 10% 
of the nominal time relative to dosing (eg, within 6 minutes of a 60 minute sample) will not 
be captured as a protocol deviation, as long as the exact time of the collection is noted on the 
source document and the CRF. Collection of samples more than 10 hours after dose 
administration that are obtained ≤1 hour away from the nominal time relative to dosing will 
not be captured as a protocol deviation, as long as the exact time of the collection is noted on 
the source document and the CRF. 
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Samples will be used to evaluate the PK of zavegepant. Samples collected for analyses of 
zavegepant plasma concentration may also be used to evaluate safety or efficacy aspects 
related to concerns arising during or after the study, or for metabolite identification and/or 
evaluation of the bioanalytical method.
Genetic analyses will not be performed on these plasma samples . Participant confidentiality 
will be maintained.
Samples collected for measurement of plasma concentrations of zavegepant will be analyzed 
using a validated analytical method in compliance with applicable SOPs.
The PK samples must be processed and shipped as indicated in the instructions provided to 
the investigator site to maintain sample integrity. Any deviations from the PK sample 
handling procedure (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 changes in the timing or addition of time points for any planned study assessments must 
be documented and approved by the relevant study team member and then archived in the 
sponsor and site study files, but will not constitute a protocol amendment. The IRB/EC will 
be informed of any safety issues that require alteration of the safety monitoring scheme or 
amendment of the ICD.
8.6. Genetics
8.6.1. Specified Genetics
Specified genetic analyses are not evaluated in this study.
8.7. Biomarkers
Biomarkers are not evaluated in this study.
8.8. Immunogenicity Assessments
Immunogenicity assessments are not included in this study.
8.9. Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study.
9. STATISTICAL CONSIDERATIONS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in the SAP, which will be maintained by the sponsor. 
The SAP 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.
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9.1. Statistical Hypotheses 
There is no statistical hypothesis for this study.
9.2. Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Participant Analysis 
Set
Description
Enrolled 
"Enrolled" means a participant's, or their legally authorized 
representative’s, agreement to participate in a clinical study 
following completion of the informed consent process and 
assignment to study intervention. A participant will be 
considered enrolled if the informed consent is not withdrawn 
prior to participating in any study activity. Potential 
participants who are screened for the purpose of determining 
eligibility for the study, but do not participate in the study, are 
not considered enrolled, unless otherwise specified by the 
protocol.
PK Concentration 
Analysis Set
All enrolled participants who receive 1 single intranasal dose
of zavegepant and provide at least 1 evaluable plasma 
concentration.
PK Parameter Analysis 
Set
All enrolled participants who receive 1 single intranasal dose 
of zavegepant and provide at least 1 evaluable PK parameters 
of interest.
Safety Analysis Set
All enrolled participants who receive 1 single intranasal dose 
of zavegepant. Participants will be analyzed according to the 
product they actually received.
9.3. Statistical Analyses
The SAP will be developed and finalized before any analyses are performed and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data.
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints.
9.3.1. General Considerations
No formal statistical tests will be performed. Descriptive summaries will be provided for all 
endpoints.
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9.3.2. Pharmacokinetic Analysis
9.3.2.1. Derivation of PK parameters
Zavegepant plasma PK parameters will be derived from the concentration-time profile using 
noncompartmental methods as detailed in Table 3. Actual PK sampling times will be used in 
the derivation of PK parameters. In the case that actual PK sampling times are not available, 
nominal PK sampling time will be used in the derivation of PK parameters.
Table 3.
Plasma PK Parameters for Protocol C5301009
Parameter
Definition
Method of Determination
Cmax
Maximum plasma concentration
Observed directly from data
AUClast
Area under the plasma 
concentration-time profile from 
time 0 to the time of the last
quantifiable concentration (Clast)
Linear/Log trapezoidal method
AUCinfa
Area under the plasma 
concentration-time profile from 
time 0 extrapolated to infinite 
time
AUClast + (Clast/kel),
where Clast is the predicted plasma
concentration at the last quantifiable 
time point estimated from the log-
linear regression analysis
Tmax
Time for Cmax
Observed directly from data 
t½a
Terminal half-life
Loge(2)/kel, where kel is the terminal
phase rate constant calculated by a 
linear regression of the log-linear
concentration-time curve
CL/Fa
Apparent clearance
Dose/AUCinf
Vz/Fa
Apparent volume of distribution
Dose/(AUCinf x kel)
a. If data permit.
9.3.2.2. Statistical Methods for Pharmacokinetic Data
The plasma concentration of zavegepant will be listed and descriptively summarized by
nominal sampling time. Individual participant and summary profiles (mean and median plots) 
of the plasma concentration-time data will be plotted using actual and nominal sampling 
times respectively.
The plasma PK parameters of zavegepant will be listed and summarized descriptively, as 
data permit. For AUClast, AUCinf, and Cmax, box and whisker plots for individual participant 
parameters overlaid with geometric means will be plotted. The PK parameter analysis set will 
be used.
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Additional specifications about the tables, listings and figures will be outlined in the SAP.
9.3.3. Safety Analyses
All safety analyses will be performed on the safety population.
AEs, ECGs, BP, pulse rate, and safety laboratory data will be reviewed and summarized on 
an ongoing basis during the study to evaluate the safety of participants. Any clinical 
laboratory, ECG, BP, and pulse rate abnormalities of potential clinical concern will be 
described. Safety data will be presented in tabular and/or graphical format and summarized 
descriptively, where appropriate.
Medical history and physical examination 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 physical examinations conducted during the 
active collection period will be captured as AEs, if those findings meet the definition of an 
AE. Data collected at screening that are used for inclusion/exclusion criteria, such as 
laboratory data, ECGs, and vital signs, will be considered source data, and will not be 
required to be reported, unless otherwise noted. Demographic data collected at screening will 
be reported.
9.3.3.1. Electrocardiogram Analyses
Changes from baseline for the ECG parameters HR, QTcF , PR interval, and QRS complex
will be summarized by time. The frequency of uncorrected QT values above 500 ms will be 
tabulated.
The number (%) of participants with maximum postdose QTcF values and maximum 
increases from baseline in the following categories will be tabulated: 
Safety QTcF Assessment
Degree of Prolongation
Mild (ms)
Moderate (ms)
Severe (ms)
Absolute value
>450-480
>480-500
>500
Increase from baseline
30-60
>60
9.4. Interim Analyses
No interim analysis will be conducted for this study. As this is an open-label study, the 
sponsor may conduct unblinded reviews of the data during the course of the study for the 
purpose of safety assessment, and/or supporting clinical development. 
9.5. Sample Size Determination
There is no statistical hypothesis for this study, therefore, the study sample size is not based 
on statistical decision rule. The sample size has been chosen based on the need to minimize 
exposure to humans of a new chemical entity and to fulfill the NMPA requirement of 
adequate PK data to support zavegepant China registration. A sufficient number of 
participants will be screened to achieve 12 participants enrolled to study intervention.
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:

Consensus ethical principles derived from international guidelines, including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines;

Applicable ICH GCP guidelines;

Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents 
(eg, advertisements) must be reviewed and approved by the sponsor, submitted to an IRB/EC 
by the investigator, and reviewed and approved by the IRB/EC before the study is initiated.
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate hazard to 
study participants.
The investigator will be responsible for the following:

Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC;

Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures;

Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH GCP guidelines, the IRB/EC, European regulation 
536/2014 for clinical studies, European Medical Device Regulation 2017/745 for 
clinical device research, and all other applicable local regulations.
10.1.1.1. 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 
regulatory 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 study 
intervention, Pfizer should be informed immediately.  
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In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of the ICH GCP guidelines that the investigator 
becomes aware of.
10.1.2. Financial Disclosure
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study.
10.1.3. Informed Consent Process
The investigator or the investigator’s representative will explain the nature of the study, 
including the risks and benefits, to the participant and answer all questions regarding the 
study. The participant should be given sufficient time and opportunity to ask questions and to 
decide whether or not to participate in the trial.
Participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, 
local regulations, ICH guidelines, privacy and data protection requirements, where 
applicable, and the IRB/EC or study center.
The investigator must ensure that each participant is fully informed about the nature and 
objectives of the study, the sharing of data related to the study, and possible risks associated 
with participation, including the risks associated with the processing of the participant’s 
personal data. 
The participant must be informed that their personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.
The participant must be informed that their medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/EC members, and by inspectors from regulatory authorities.
The investigator further must ensure that each study participant is fully informed about 
theirright to access and correct their personal data and to withdraw consent for the processing 
of their personal data.
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date on which the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICD.
Participants must be reconsented to the most current version of the IRB/EC-approved ICD(s) 
during their participation in the study as required per local regulations.
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A copy of the ICD(s) must be provided to the participant.
10.1.4. Data Protection
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data.
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password protected or secured in a locked room to ensure that only 
authorized study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site will be responsible for 
determining whether a personal data breach has in fact occurred and, if so, providing breach 
notifications as required by law.
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant-specific numerical code. Any 
participant records or data sets that are transferred to the sponsor will contain the numerical 
code; participant names will not be transferred. All other identifiable data transferred to the 
sponsor will be identified by this single, participant-specific code. The study site will 
maintain a confidential list of participants who participated in the study, linking each 
participant’s numerical code to their actual identity and medical record ID. In case of data 
transfer, the sponsor will protect the confidentiality of participants’ personal data consistent 
with the clinical study agreement and applicable privacy laws.
Information technology systems used to collect, process, and store study-related data are 
secured by technical and organizational security measures designed to protect such data 
against accidental or unlawful loss, alteration, or unauthorized disclosure or access.
The sponsor maintains standard operating procedures on how to respond in the event of 
unauthorized access, use, or disclosure of sponsor information or systems.
10.1.5. Committees Structure
10.1.5.1. Data Monitoring Committee 
This study will not use an E-DMC.
10.1.6. Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT/CTIS, and/or 
www.pfizer.com, and other public registries and websites in accordance with applicable local 
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs.
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 
which the study was conducted.
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www.clinicaltrials.gov
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in patients) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted. These results are 
submitted for posting in accordance with the format and timelines set forth by US law.
EudraCT/CTIS
Pfizer posts clinical trial results on EudraCT/CTIS for Pfizer-sponsored interventional studies 
in accordance with the format and timelines set forth by EU requirements.
www.pfizer.com
Pfizer posts CSR synopses and plain-language study results summaries on www.pfizer.com 
for Pfizer-sponsored interventional studies at the same time the corresponding study results 
are posted to www.clinicaltrials.gov. CSR synopses will have personally identifiable 
information anonymized.
Documents within marketing applications
Pfizer complies with applicable local laws/regulations to publish clinical documents included 
in marketing applications. Clinical documents include summary documents and CSRs 
including the protocol and protocol amendments, sample CRFs, and SAPs. Clinical 
documents will have personally identifiable information anonymized.
Data sharing
Pfizer provides researchers secure access to participant-level data or full CSRs for the 
purposes of “bona-fide scientific research” that contributes to the scientific understanding of 
the disease, target, or compound class. Pfizer will make data from these trials available 
24 months after study completion. Participant-level data will be anonymized in accordance 
with applicable privacy laws and regulations. CSRs will have personally identifiable 
information anonymized.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.7. Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
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Guidance on completion of CRFs will be provided in the CRF Completion Requirements 
document.
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password-protected or secured in a locked room to 
prevent access by unauthorized third parties.
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents. This 
verification may also occur after study completion. 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.
Monitoring details describing strategy, including definition of study-critical data items and 
processes (eg, risk-based initiatives in operations and quality, such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques 
(central, virtual, or on-site monitoring), are provided in the data management plan and/or the 
site monitoring plan maintained and utilized by the sponsor or designee.
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data.
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. The 
investigator must ensure that the records continue to be stored securely for as long as they are 
maintained.
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems.
The investigator(s) will notify the sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study. Furthermore, the investigator will cooperate
with the sponsor or its agents to prepare the investigator site for the inspection and will allow 
the sponsor or its agent, whenever feasible, to be present during the inspection. The 
investigator site and investigator will promptly resolve any discrepancies that are identified 
between the study data and the participant’s medical records. The investigator will promptly 
provide copies of the inspection findings to the sponsor or its agent. Before response 
submission to the regulatory authorities, the investigator will provide the sponsor or its 
agents with an opportunity to review and comment on responses to any such findings.
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10.1.8. Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator site.
Data reported on the CRF or entered in the eCRF that are from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on 
the study. Also, current medical records must be available.
Definition of what constitutes source data and its origin can be found in the Source 
Document Locator, which is maintained by the sponsor.
Description of the use of the computerized system is documented in the Data Management 
Plan which is maintained by the sponsor.
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
The sponsor or designee will perform monitoring to confirm that data entered into the CRF 
by authorized site personnel are accurate, complete, and verifiable from source documents; 
that the safety and rights of participants are being protected; and that the study is being 
conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP guidelines, and all applicable regulatory requirements.
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10.1.9. Study and Site Start and Closure
The study start date is the date on which the clinical study will be open for recruitment of 
participants.
The first act of recruitment is the date of the first participant’s first visit and will be the study 
start date.
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor, including (but not limited to) 
regulatory authority decision, change in opinion of the IRB/EC, or change in benefit-risk 
assessment. Study sites will be closed upon study completion. A study site is considered 
closed when all required documents and study supplies have been collected and a study-site 
closure visit has been performed.
The investigator may initiate study-site closure at any time upon notification to the sponsor if 
requested to do so by the responsible IRB/EC or if such termination is required to protect the 
health of study participants.
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:

Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor’s procedures, or the ICH GCP 
guidelines;

Inadequate recruitment of participants by the investigator;

Discontinuation of further study intervention development.
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 
requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.
Study termination is also provided for in the clinical study agreement. If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights.
10.1.10. Publication Policy
For multicenter trials, the primary publication will be a joint publication developed by the 
investigator and Pfizer reporting the primary endpoint(s) of the study covering all study sites. 
The investigator agrees to refer to the primary publication in any subsequent publications. 
Pfizer will not provide any financial compensation for the investigator’s participation in the 
preparation of the primary congress abstract, poster, presentation, or primary manuscript for 
the study.
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Investigators are free to publish individual center results that they deem to be clinically 
meaningful after publication of the overall results of the study or 12 months after primary 
completion date or study completion at all sites, whichever occurs first, subject to the other 
requirements described in this section.
The investigator will provide Pfizer an opportunity to review any proposed publication or 
any other type of disclosure of the study results (collectively, “publication”) before it is 
submitted or otherwise disclosed and will submit all publications to Pfizer 30 days before 
submission. 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 
upon request from Pfizer. This allows Pfizer to protect proprietary information and to provide 
comments, and the investigator will, on request, remove any previously undisclosed
confidential information before disclosure, except for any study-intervention or Pfizer-related 
information necessary for the appropriate scientific presentation or understanding of the 
study results.  For joint publications, should there be disagreement regarding interpretation 
and/or presentation of specific analysis results, resolution of, and responsibility for, such 
disagreements will be the collective responsibility of all authors of the publication.
For all publications relating to the study, the investigator and Pfizer will comply with 
recognized ethical standards concerning publications and authorship, including those 
established by the International Committee of Medical Journal Editors. The investigator will 
disclose any relationship with Pfizer and any relevant potential conflicts of interest, including 
any financial or personal relationship with Pfizer, in any publications. All authors will have 
access to the relevant statistical tables, figures, and reports (in their original format) required 
to develop the publication.
10.1.11. Sponsor’s Medically Qualified Individual
The contact information for the sponsor’s MQI for the study is documented in the study 
contact list located in the StoD System.
To facilitate access to their investigator and the sponsor’s MQI for study-related medical 
questions or problems from nonstudy healthcare professionals, participants are provided with 
an ECC at the time of informed consent. The ECC contains, at a minimum, (a) protocol and 
study intervention identifiers, (b) participant’s study identification number, (c) site 
emergency phone number active 24 hours/day, 7 days per week, and (d) Pfizer Call Center 
number.
The ECC is intended to augment, not replace, the established communication pathways 
between the participant and their investigator and site staff, and between the investigator and 
sponsor study team. The ECC is only to be used by healthcare professionals not involved in 
the research study, as a means of reaching the investigator or site staff related to the care of a 
participant. The Pfizer Call Center number is to be used when the investigator and site staff 
are unavailable. The Pfizer Call Center number is not for use by the participant directly; if a 
participant calls that number directly, they will be directed back to the investigator site.
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10.2. Appendix 2: Clinical Laboratory Tests
The following safety laboratory tests will be performed at times defined in the SoA 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 laboratory measurements may be obtained at any time during the 
study to assess any perceived safety issues.
Table 4.
Protocol-Required Safety Laboratory Assessments
Hematology
Chemistry
Urinalysis
Other
Hemoglobin
Hematocrit
RBC count
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
Microscopya
COVID-19 teste
At screening and/or Day-1:

FSHb

Alcohol test

Urine cotinine

Urine drug screeningc

Pregnancy test (β-hCG)d

HBsAg

HCVAb

HIV

Syphilis test (TPPA)
a.
Only if UTI is suspected or urine blood, protein, nitrites or leukocyte esterase is positive.
b.
For confirmation of postmenopausal status only.
c.
The minimum requirement for drug screening includes cocaine, THC, opiates/opioids, benzodiazepines, 
and amphetamines (others are site and study specific).
d.
Local urine testing will be standard for the protocol unless serum testing is required by local regulation 
or IRB/EC. Serum or urine -hCG for female participants of childbearing potential.
e.
The timing and methods of COVID-19 test(s) should follow the requirements from local regulations or
investigator (CRU).
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF.
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10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting
10.3.1. Definition of AE
AE Definition

An AE is any untoward medical occurrence in a patient or clinical study 
participant, temporally associated with the use of study intervention, whether 
or not considered related to the study intervention.

Note: An AE can therefore be any unfavorable and unintended sign (including 
an abnormal laboratory finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention.
Events Meeting the AE Definition

Any abnormal laboratory test results (hematology, clinical chemistry, or 
urinalysis) or other safety assessments (eg, ECG, radiological scans, vital sign 
measurements), including those that worsen from baseline, considered clinically 
significant in the medical and scientific judgment of the investigator. Any 
abnormal laboratory test results that meet any of the conditions below must be 
recorded as an AE:

Is associated with accompanying symptoms;

Requires additional diagnostic testing or medical/surgical intervention;

Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional 
concomitant drug treatment, or other therapy.

Exacerbation of a chronic or intermittent preexisting condition, including an 
increase in either frequency and/or intensity of the condition.

New condition detected or diagnosed after study intervention administration,
even though it may have been present before the start of the study.

Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.

Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as 
an AE or SAE unless it is an intentional overdose taken with possible 
suicidal/self-harming intent. Such overdoses should be reported regardless of 
sequelae.
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Events NOT Meeting the AE Definition

Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.

The disease/disorder being studied or expected progression, signs, or symptoms 
of the disease/disorder being studied, unless more severe than expected for the 
participant’s condition.

Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE.

Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).

Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) 
present or detected at the start of the study that do not worsen.
10.3.2. Definition of an SAE
An SAE is defined as any untoward medical occurrence that, at any dose, meets one 
or more of the criteria listed below:
a. Results in death
b. Is life-threatening
The term “life-threatening” in the definition of “serious” refers to an event in which 
the participant was at risk of death at the time of the event. It does not refer to an 
event that hypothetically might have caused death if it were more severe.
c.
Requires inpatient hospitalization or prolongation of existing hospitalization
In general, hospitalization signifies that the participant has been admitted (usually 
involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the physician’s 
office or outpatient setting. Complications that occur during hospitalization are AEs. 
If a complication prolongs hospitalization or fulfills any other serious criteria, the 
event is serious. When in doubt as to whether “hospitalization” occurred or was 
necessary, the AE should be considered serious.
Hospitalization for elective treatment of a preexisting condition that did not worsen 
from baseline is not considered an AE.
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d. Results in persistent or significant disability/incapacity

The term disability means a substantial disruption of a person’s ability to 
conduct normal life functions.

This definition is not intended to include experiences of relatively minor 
medical significance, such as uncomplicated headache, nausea, vomiting, 
diarrhea, influenza, and accidental trauma (eg, sprained ankle), that may 
interfere with or prevent everyday life functions but do not constitute a 
substantial disruption.
e.
Is a congenital anomaly/birth defect
f.
Is a suspected transmission via a Pfizer product of an infectious agent, 
pathogenic or non-pathogenic 
The event may be suspected from clinical symptoms or laboratory findings 
indicating an infection in a participant exposed to a Pfizer product. The terms 
“suspected transmission” and “transmission” are considered synonymous. These 
cases are considered unexpected and handled as serious expedited cases by 
pharmacovigilance personnel. Such cases are also considered for reporting as 
product defects, if appropriate.
g. Other situations:

Medical or scientific judgment should be exercised by the investigator in 
deciding whether SAE reporting is appropriate in other situations, such as 
significant medical events that may jeopardize the participant or may 
require medical or surgical intervention to prevent one of the other 
outcomes listed in the above definition. These events should usually be 
considered serious.

Examples of such events include invasive or malignant cancers, 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.
10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During the Active 
Collection Period
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording AEs on the CRF and for 
reporting SAEs on the CT SAE Report Form to Pfizer Safety throughout the active 
collection period. These requirements are delineated for 3 types of events: (1) SAEs; (2) 
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nonserious AEs; and (3) exposure to the study intervention under study during 
pregnancy or breastfeeding, and occupational exposure. 
It should be noted that the CT SAE Report Form for reporting of SAE information is not 
the same as the AE page of the CRF. When the same data are collected, the forms must 
be completed in a consistent manner. AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE 
Report Form for reporting of SAE information.
Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours 
of Awareness
SAE
All
All
Nonserious AE
All
None
Exposure to the study 
intervention under study 
during pregnancy or 
breastfeeding
All AEs/SAEs associated 
with EDP or EDB
Note: Instances of EDP or 
EDB not associated with an 
AE or SAE are not captured 
in the CRF
All instances of EDP are 
reported (whether or not 
there is an associated 
SAE)*
All instances of EDB are 
reported (whether or not 
there is an associated 
SAE)**
Environmental or 
occupational exposure 
to the product under 
study to a 
nonparticipant (not 
involving EDP or EDB)
None. Exposure to a study 
non-participant is not 
collected on the CRF
The exposure (whether or 
not there is an associated 
AE or SAE) must be 
reported***
*
EDP (with or without an associated AE or SAE): any pregnancy information is reported to 
Pfizer Safety using the CT SAE Report Form and EDP Supplemental Form; if the EDP is 
associated with an SAE, then the SAE is reported to Pfizer Safety using the CT SAE Report 
Form. 
** EDB is reported to Pfizer Safety using the CT SAE Report Form, which would also include 
details of any SAE that might be associated with the EDB. 
*** Environmental or occupational exposure: AEs or SAEs associated with occupational exposure 
are reported to Pfizer Safety using the CT SAE Report Form. 

When an AE or SAE occurs, it is the responsibility of the investigator to 
review all documentation (eg, hospital progress notes, laboratory reports, and 
diagnostic reports) related to the event.
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
The investigator will then record all relevant AE or SAE information in the 
CRF.

It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of completion of the CT SAE Report 
Form/AE or SAE CRF page.

There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the 
exception of the participant number, will be redacted on the copies of the 
medical records before submission to Pfizer Safety.

The investigator will attempt to establish a diagnosis of the event based on 
signs, symptoms, and/or other clinical information. Whenever possible, the 
diagnosis (not the individual signs/symptoms) will be documented as the AE
or SAE.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the following categories: 

Mild: A type of AE that is usually transient and may require only minimal 
treatment or therapeutic intervention.  The event does not generally interfere 
with usual ADL.

Moderate: A type of AE that is usually alleviated with additional specific 
therapeutic intervention. The event interferes with usual ADL, causing 
discomfort, but poses no significant or permanent risk of harm to the research 
participant.

Severe: A type of AE that interrupts usual ADL, or significantly affects 
clinical status, or may require intensive therapeutic intervention.
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe.
Assessment of Causality

The investigator is obligated to assess the relationship between study 
intervention and each occurrence of each AE or SAE. The investigator will use 
clinical judgment to determine the relationship.
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
A “reasonable possibility” of a relationship conveys that there are facts, 
evidence, and/or arguments to suggest a causal relationship, rather than a 
relationship cannot be ruled out.

Alternative causes, such as underlying disease(s), concomitant therapy, and 
other risk factors, as well as the temporal relationship of the event to study 
intervention administration, will be considered and investigated.

The investigator will also consult the IB and/or product information, for 
marketed products, in their assessment.

For each AE or SAE, the investigator must document in the medical notes that 
they have reviewed the AE or SAE and have provided an assessment of 
causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it 
is very important that the investigator always make an assessment of 
causality for every event before the initial transmission of the SAE data to 
the sponsor.

The investigator may change their opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality 
assessment.

The causality assessment is one of the criteria used when determining 
regulatory reporting requirements.

If the investigator does not know whether or not the study intervention caused 
the event, then the event will be handled as “related to study intervention” for 
reporting purposes, as defined by the sponsor. 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, and 
report such an assessment in the dedicated section of the CT SAE Report Form 
and in accordance with the SAE reporting requirements.
Follow-Up of AEs and SAEs

The investigator is obligated to perform or arrange for the conduct of 
supplemental measurements and/or evaluations, as medically indicated or as 
requested by the sponsor, to elucidate the nature and/or causality of the AE or 
SAE as fully as possible. This may include additional laboratory tests or 
investigations, histopathological examinations, or consultation with other 
healthcare providers.
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
New or updated information will be recorded in the originally submitted 
documents.

The investigator will submit any updated SAE data to the sponsor within 24 
hours of receipt of the information.
10.3.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic DCT

The primary mechanism for reporting an SAE to Pfizer Safety will be the 
electronic DCT.

If the electronic system is unavailable, then the site will use the paper SAE 
DCT (see next section) to report the event within 24 hours.

The site will enter the SAE data into the electronic DCT (eg, eSAE or PSSA) 
or paper form (as applicable) as soon as the data become available.

After the study is completed at a given site, the electronic DCT will be taken 
off-line to prevent the entry of new data or changes to existing data.

If a site receives a report of a new SAE from a study participant or receives 
updated data on a previously reported SAE after the electronic DCT has been 
taken off-line, then the site can report this information on a paper SAE form 
(see next section) or to Pfizer Safety by telephone.
SAE Reporting to Pfizer Safety via the CT SAE Report Form

Facsimile transmission of the CT SAE Report Form is the preferred method to 
transmit this information to Pfizer Safety.

In circumstances when the facsimile is not working, an alternative method 
should be used, eg, secured (Transport Layer Security) or password-protected 
email. If none of these methods can be used, notification by telephone is 
acceptable with a copy of the CT SAE Report Form sent by overnight mail or 
courier service.

Initial notification via telephone does not replace the need for the investigator 
to complete and sign the CT SAE Report Form pages within the designated 
reporting time frames.
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10.4. Appendix 4: Contraceptive and Barrier Guidance
10.4.1. Male Participant Reproductive Inclusion Criteria
No contraception methods are required for male participants in this study, as the calculated 
safety margin is ≥100-fold between the estimated maternal exposure due to seminal transfer 
and the NOAEL for serious manifestations of developmental toxicity in nonclinical studies.
10.4.2. Female Participant Reproductive Inclusion Criteria
The criteria below are part of Inclusion Criterion 1 (Age and Sex; Section 5.1) and specify 
the reproductive requirements for including female participants. Refer to Section 10.4.4 for a 
complete list of contraceptive methods permitted in the study. 
A female participant is eligible to participate if she is not pregnant or breastfeeding and at 
least 1 of the following conditions applies:

Is not a WOCBP (see definitions below in Section 10.4.3).
OR

Is a WOCBP and agrees to use an acceptable contraceptive method during the 
intervention period (for a minimum of 28 days after the last dose of study 
intervention).  The investigator should evaluate the effectiveness of the 
contraceptive method in relationship to the first dose of study intervention.
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy.
10.4.3. Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below).
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before the first dose of study intervention, additional evaluation should be 
considered.
Women in the following categories are not considered WOCBP:
1.
Premenarchal.
2.
Premenopausal female with 1 of the following:

Documented hysterectomy;

Documented bilateral salpingectomy;
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
Documented bilateral oophorectomy.
For individuals with permanent infertility due to a medical cause other than the above
(eg, mullerian agenesis, androgen insensitivity), investigator discretion should be applied 
to determining study entry.
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview. The method of documentation should be recorded in the participant’s medical 
record for the study.
3.
Postmenopausal female.

A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause. In addition:

A high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years old and not using hormonal 
contraception or HRT. 

A female on HRT and whose menopausal status is in doubt will be required to 
use one of the highly effective nonestrogen hormonal contraception methods 
if she wishes to continue her HRT during the study. Otherwise, she must 
discontinue HRT to allow confirmation of postmenopausal status before study 
enrollment.
10.4.4. Contraception Methods
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.
The following contraceptive methods are appropriate for this study:
Highly Effective Methods That Have Low User Dependency 
1.
Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation.
2.
Intrauterine device.
3.
Intrauterine hormone-releasing system.
4.
Bilateral tubal occlusion.
5.
Vasectomized partner:

Vasectomized partner is a highly effective contraceptive method provided that 
the partner is the sole sexual partner of the WOCBP and the absence of sperm 
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has been confirmed. If not, an additional highly effective method of 
contraception should be used. The spermatogenesis cycle is approximately 90 
days.
Highly Effective Methods That Are User Dependent 
6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:

Oral;

Intravaginal;

Transdermal.
7. Progestogen-only hormone contraception associated with inhibition of ovulation:

Oral;

Injectable.
Sexual Abstinence
8. Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention. The reliability of sexual abstinence needs to be 
evaluated in relation to the duration of the study and the preferred and usual 
lifestyle of the participant.
Other Effective Methods
9. Progestogen-only oral hormonal contraception where inhibition of ovulation is not the 
primary mode of action.
10. Male or female condom, with or without spermicide.
11. Cervical cap, diaphragm, or sponge with spermicide.
12. A combination of male condom with either cervical cap, diaphragm, or sponge 
with spermicide (double-barrier methods).
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10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-Up Assessments
Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome. These participants fail to adapt and therefore are 
“susceptible” to progressive and serious liver injury, commonly referred to as DILI. 
Participants who experience a transaminase elevation above 3 × ULN should be monitored 
more frequently to determine if they are “adaptors” or are “susceptible.”
In the majority of DILI cases, elevations in AST and/or ALT precede T bili elevations 
(>2 × ULN) by several days or weeks. The increase in T bili typically occurs while 
AST/ALT is/are still elevated above 3 × ULN (ie, AST/ALT and T bili values will be 
elevated within the same laboratory sample). In rare instances, by the time T bili elevations 
are detected, AST/ALT values might have decreased. This occurrence is still regarded as a 
potential DILI. Therefore, abnormal elevations in either AST OR ALT in addition to T bili 
that meet the criteria outlined below are considered potential DILI (assessed per Hy’s law 
criteria) cases and should always be considered important medical events, even before all 
other possible causes of liver injury have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions. Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values:

Participants with AST/ALT and T bili baseline values within the normal range who 
subsequently present with AST OR ALT values ≥3 × ULN AND a T bili value 
≥2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available.

For participants with baseline AST OR ALT OR T bili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline:

Preexisting AST or ALT baseline values above the normal range: AST or ALT 
values ≥2 times the baseline values AND ≥3 × ULN; or ≥8 × ULN (whichever is 
smaller).

Preexisting values of T bili above the normal range: T bili level increased from 
baseline value by an amount of  ≥1 × ULN or if the value reaches ≥3 × ULN 
(whichever is smaller).
Rises in AST/ALT and T bili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor. 
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The participant should return to the investigator 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 and T bili for suspected Hy’s law 
cases, additional laboratory tests should include albumin, CK, direct and indirect bilirubin, 
GGT, PT/INR, total bile acids, and alkaline phosphatase. Consideration should also be given 
to drawing a separate tube of clotted blood and an anticoagulated tube of blood for further 
testing, as needed, for further contemporaneous analyses at the time of the recognized initial 
abnormalities to determine etiology. A detailed history, including relevant information, such 
as review of ethanol, acetaminophen/paracetamol (either by itself or as a coformulated 
product in prescription or over-the-counter medications), recreational drug, or supplement 
(herbal) use and consumption, family history, sexual history, travel history, history of contact 
with a jaundiced person, surgery, blood transfusion, history of liver or allergic disease, and 
potential occupational exposure to chemicals, should be collected. Further testing for acute 
hepatitis A, B, C, D, and E infection, liver imaging (eg, biliary tract), and collection of blood
samples for acetaminophen/paracetamol drug and/or protein adduct levels may be warranted. 
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
T bili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found. Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.
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10.6. Appendix 6: ECG Findings of Potential Clinical Concern
ECG Findings That May Qualify as AEs

Marked sinus bradycardia (rate <40 bpm) lasting minutes.

New PR interval prolongation >280 ms.

New prolongation of QTcF to >480 ms (absolute) or by ≥60 ms from baseline.

New-onset atrial flutter or fibrillation, with controlled ventricular response rate: 
ie, rate <120 bpm.

New-onset type I second-degree (Wenckebach) AV block of >30 seconds’
duration.

Frequent PVCs, triplets, or short intervals (<30 seconds) of consecutive 
ventricular complexes.
ECG Findings That May Qualify as SAEs

QTcF prolongation >500 ms.

New ST-T changes suggestive of myocardial ischemia.

New-onset LBBB (QRS complex>120 ms).

New-onset right bundle branch block (QRS complex>120 ms).

Symptomatic bradycardia.

Asystole:

In awake, symptom-free participants in sinus rhythm, with documented 
periods of asystole ≥3.0 seconds or any escape rate <40 bpm, or with an 
escape rhythm that is below the AV node. 

In awake, symptom-free participants with atrial fibrillation and bradycardia 
with 1 or more pauses of at least 5 seconds or longer. 

Atrial flutter or fibrillation, with rapid ventricular response rate: rapid = rate 
>120 bpm.

Sustained supraventricular tachycardia (rate >120 bpm) (“sustained” = short 
duration with relevant symptoms or lasting >1 minute).

Ventricular rhythms >30 seconds’ duration, including idioventricular rhythm 
(HR <40 bpm), accelerated idioventricular rhythm (HR >40 bpm to <100 bpm),
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and monomorphic/polymorphic ventricular tachycardia (HR >100 bpm [such as
torsades de pointes]).

Type II second-degree (Mobitz II) AV block.

Complete (third-degree) heart block.
ECG Findings That Qualify as SAEs

Change in pattern suggestive of new myocardial infarction.

Sustained ventricular tachyarrhythmias (>30 seconds’ duration).

Second- or third-degree AV block requiring pacemaker placement.

Asystolic pauses requiring pacemaker placement.

Atrial flutter or fibrillation with rapid ventricular response requiring 
cardioversion.

Ventricular fibrillation/flutter.

At the discretion of the investigator, any arrhythmia classified as an adverse 
experience.
The enumerated list of major events of potential clinical concern are recommended as “alerts” or 
notifications from the core ECG laboratory to the investigator and Pfizer study team, and not to be 
considered as all-inclusive of what to be reported as AEs/SAEs.
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10.7. Appendix 7: Abbreviations
The following is a list of abbreviations that may be used in the protocol. 
Abbreviation
Term
Abs
absolute
ADL
activity/activities of daily living
ADME
Absorption Distribution Metabolism Excretion
AE
adverse event
ALC
absolute lymphocyte count
ALT
alanine aminotransferase
ANC
absolute neutrophil count
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
AUCinf
area under the plasma concentration-time profile from time 0 
extrapolated to infinite time
AUClast
area under the plasma concentration-time profile from time 0 to the 
time of the last quantifiable concentration (Clast)
AV
atrioventricular
AxMP
auxiliary medicinal product
-hCG
-human chorionic gonadotropin
BMI
body mass index
BP
blood pressure
bpm
beats per minute
BUN
blood urea nitrogen
CFR
Code of Federal Regulations
CGRP
calcitonin gene-related peptide
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CL/F 
apparent clearance
Clast
the last quantifiable concentration
Cmax
maximum observed concentration
CO2
carbon dioxide (bicarbonate)
COVID-19
coronavirus disease 2019
CrCl
creatinine clearance
CRF
case report form
CRO
contract research organization
CRU
clinical research unit
CSR
Clinical Study Report
CT
calcitonin
CTIS
Clinical Trial Information System
CV
cardiovascular
CYP
cytochrome P450
DCT
data collection tool
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Abbreviation
Term
DILI
drug-induced liver injury
EC
ethics committee
ECC
emergency contact card
ECG
electrocardiogram or electrocardiography
eCRF
electronic case report form
EDB
exposure during breastfeeding
E-DMC
External Data Monitoring Committee
EDP
exposure during pregnancy
eSAE
electronic serious adverse event
EU
European Union
EudraCT
European Union Drug Regulating Authorities Clinical Trials 
(European Clinical Trials Database)
FSH
follicle-stimulating hormone
F/U
follow-up
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
HBsAg 
hepatitis B surface antigen
HCVAb
hepatitis C antibody
HIV
human immunodeficiency virus
HR
heart rate
HRT
hormone replacement therapy
IB
Investigator’s Brochure
ICD
Informed Consent Document
ICH
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use
ID
identification
IMP
investigational medicinal product
IN
intranasal
IND
Investigational New Drug 
INR
international normalized ratio
IP
investigational product
IPAL
Investigational Product Accountability Log
IPM
investigational product manual
IRB
Institutional Review Board
IV
intravenous
LBBB
left bundle branch block
LFT
liver function test
MOH
medication-overuse headache
MQI
medically qualified individual
NIMP
non-investigational medicinal product
NMPA
National Medical Products Administration
NOAEL
no observed adverse effect level
OTC
over-the-counter
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Abbreviation
Term
PCP
phencyclidine
PE
physical examination
PI
Primary Investigator
PK
pharmacokinetic(s)
PPK
Population Pharmacokinetic
PSSA
Pfizer's Serious Adverse Event Submission Assistant
PVC
premature ventricular contraction/complex
QD
once daily
QTc
corrected QT interval
QTcF
QTc corrected using Fridericia’s formula
RBC
red blood cell
SAE
serious adverse event
SAP
Statistical Analysis Plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SoA
schedule of activities
SOP
standard operating procedure
SRSD
Single Reference Safety Document
SUSAR
Suspected Unexpected Serious Adverse Reaction
t½
terminal half-life
T bili
total bilirubin
THC
tetrahydrocannabinol
ULN
upper limit of normal
Tmax
time for Cmax
TPPA
Treponema pallidum particle agglutination
US
United States
UTI
urinary tract infection
Vz/F 
apparent volume of distribution
WBC
white blood cell
WOCBP
woman/women of childbearing potential
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11. REFERENCES
1.
Banholzer ML, Wandel C, Barrow P, et al. Clinical trial considerations on male 
contraception and collection of pregnancy information from female partner: update. Clin 
Transl Med 2016;5(1):23-37.
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