| Eligibility |
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria
apply:
Age and Sex:
1. Healthy (except obese) female participants of non-childbearing potential and/or male
participants, at the time of screening, must be 18 to 60 years of age, inclusive, at
the time of signing the informed consent document (ICD).
2. Male and female of non-child bearing potential participants, who are healthy as
determined by medical evaluation including medical history, physical examination,
vital assessments, 12 lead ECGs, and laboratory tests.
3. Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.
Weight:
4. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
5. Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the ICD and the protocol.
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,
immunological/rheumatological, or allergic disease (including drug allergies, but
excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
2. Participants who have any visible skin damage or skin condition (eg sunburn,
excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous
freckles, or other disfigurations) in or around the application site which, in the
opinion of the investigative personnel, will interfere with the evaluation of the test
site reaction.
3. Participants who have a history of or have active AD/eczema/urticaria.
4. Evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB) as defined by both of the following:
- A positive QuantiFERON TB Gold In-tube or equivalent test (QFT).
- History of either untreated or inadequately treated latent or active TB
infection, or current treatment for the same.
5. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV,
hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C
antibody (HCVAb). Hepatitis B vaccination is allowed. As an exception a positive HBsAb
test due to hepatitis B vaccination is permissible.
6. Have a history of systemic infection requiring hospitalization, parenteral
antimicrobial therapy, or as otherwise judged clinically significant by the
investigator within 6 months prior to Day 1.
7. A history (single episode) of disseminated herpes zoster or disseminated herpes
simplex, or a recurrent (more than one episode of) localized, dermatomal herpes
zoster.
8. Acute disease state (unstable medical condition such as nausea, vomiting, fever or
diarrhea, etc) within 7 days of Day 1.
9. Have any malignancies or have a history of malignancies with the exception of
adequately treated or excised non-metastatic basal cell or squamous cell cancer of the
skin.
10. Have a first-degree relative with hereditary immunodeficiency.
11. A history of any lymphoproliferative disorder (such as Epstein Barr Virus [EBV]
-related lymphoproliferative disorder), history of lymphoma, leukemia, malignancies or
signs and symptoms suggestive of current lymphatic disease.
12. Have undergone significant trauma or major surgery within 4 weeks of screening.
13. 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 (eg. Contact with positive case, residence, or
travel to an area with high incidence) that may increase the risk of study
participation or, in the investigator's judgment, make the participant inappropriate
for the study.
Prior/Concomitant Therapy:
14. Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half lives (whichever is longer) prior to the first dose of study
intervention. (Refer to Section 6.8 Concomitant Therapy for additional details).
15. Participants who are vaccinated with vaccines that have live components (or live
attenuated vaccines) within the 6 weeks prior to the first dose of PF-07295324/vehicle
or PF-07259955/vehicle or who are expected to be vaccinated during treatment or during
follow-up period.
NOTE regarding COVID vaccines with authorization or approval for emergency use:
There is no requirement for washout of COVID vaccines prior to the first dose of
PF-07295324/vehicle or PF-07259955/vehicle if the vaccine is not live attenuated (eg,
mRNA, utilizing a viral vector,inactivated virus).There is no protocol-specified
requirement for the interruption of IP dosing prior to or after vaccination if the
COVID vaccine is not live attenuated.
16. Participants in any cohort of this study can only be randomized and receive the IP in
only 1 cohort of this study.
Prior/Concurrent Clinical Study Experience:
17. Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half lives preceding the first dose of study
intervention used in this study (whichever is longer).
Diagnostic Assessments:
18. A positive urine drug test.
19. 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.
20. Baseline 12 lead electrocardiogram (ECG) that demonstrates clinically relevant
abnormalities that may affect participant safety or interpretation of study results
(eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block
[LBBB], signs of an acute or indeterminate age myocardial infarction, ST T interval
changes suggestive of myocardial ischemia, second or third degree atrioventricular
[AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline
uncorrected QT interval is >450 msec, this interval should be rate corrected using the
Fridericia method and the resulting QTcF should be used for decision making and
reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be
repeated 2 more times and the average of the 3 QTc or QRS values should be used to
determine the participant's eligibility. Computer interpreted ECGs should be overread
by a physician experienced in reading ECGs before excluding participants.
21. 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:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level =1.5 ×
upper limit of normal (ULN);
- Total bilirubin level =1.5 × 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.
Other Exclusions:
22. History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5
(male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,
alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1
ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
23. Use of tobacco/nicotine containing products more than 5 cigarettes/day.
24. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.
25. History of serious adverse reactions or hypersensitivity to any topical drug; or known
allergy to any of the test product(s) or any components in the test product(s) or
history of hypersensitivity; or allergic reactions to any of the study preparations as
described in the PF-07295324 IB and PF-07259955 IB.
26. Not willing to refrain from shaving, the use of depilatories or other hair-removal
activities, antiperspirants, lotions, skin creams, fragrances or perfumes, or body
oils (eg, baby oil; coconut oil), use of hair products, hair gels, and hair oil in the
treatment areas for 48 hours prior to admission to the CRU and for the duration of the
stay in the CRU.
27. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.
28. Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members.
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