- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05206604
A First-in-human Study of Multiple Doses of Topically Administered PF-07295324 and PF-07259955
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, VEHICLE-CONTROLLED, FIRST-IN-HUMAN, MULTIPLE-DOSE STUDY, TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS, OF TOPICALLY ADMINISTERED PF-07295324 AND PF-07259955, IN HEALTHY ADULT PARTICIPANTS
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- New Haven Clinical Research Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
- 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).
- 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.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Weight:
- Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
- 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:
- 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).
- 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.
- Participants who have a history of or have active AD/eczema/urticaria.
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.
- 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.
- 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.
- A history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
- Acute disease state (unstable medical condition such as nausea, vomiting, fever or diarrhea, etc) within 7 days of Day 1.
- 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.
- Have a first-degree relative with hereditary immunodeficiency.
- 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.
- Have undergone significant trauma or major surgery within 4 weeks of screening.
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:
- 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).
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.
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:
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:
- A positive urine drug test.
- 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.
- 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.
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:
- 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).
- Use of tobacco/nicotine containing products more than 5 cigarettes/day.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- 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.
- 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.
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PF-07295324
Ointment
|
Ointment
|
Experimental: PF-07259955
Cream
|
Cream
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AEs following multiple ascending dose (MAD)
Time Frame: Day 1 up to Day 10
|
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
|
Day 1 up to Day 10
|
Incidence and severity of application site Adverse Events (AEs) as assessed by Draize score.
Time Frame: Day 1 up to Day 10
|
Frequency and severity of skin irritation potential based on Draize scoring
|
Day 1 up to Day 10
|
Incidence of laboratory abnormalities
Time Frame: Day 1 up to Day 10
|
Number of subjects with laboratory abnormalities
|
Day 1 up to Day 10
|
Number of subjects with change from baseline in vital signs
Time Frame: day 1 and day 10
|
Number of subjects with change from baseline of blood pressure and pulse rate
|
day 1 and day 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to reach maximum plasma concentration (Cmax)
Time Frame: Day 1 and Day 10
|
Maximum observed plasma concentration (Cmax)
|
Day 1 and Day 10
|
Time to reach plasma Cmax (Tmax)
Time Frame: Day 1 and Day 10
|
Time to reach maximum observed plasma concentration (Tmax)
|
Day 1 and Day 10
|
Average Plasma Concentration (Cave)
Time Frame: Day 1 and Day 10
|
Average Plasma Concentration over the duration of dosing interval, where dosing interval is 12 hours.
|
Day 1 and Day 10
|
Minimum Observed Plasma Trough Concentration (Ctrough)
Time Frame: Day 1 and Day 10
|
Minimum plasma concentration over the dosing interval τau (12 hour) from first dose to last dose
|
Day 1 and Day 10
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCτau)
Time Frame: Day 1 and Day 10
|
Area under the concentration curve from time 0 to end of dosing interval (AUCτau), where dosing interval is 12 hours.
|
Day 1 and Day 10
|
Observed Accumulation Ratio for Cmax (Rac,Cmax)
Time Frame: Day 10
|
Accumulation ratio based on maximum plasma concentration (Cmax) calculated as: Rac,Cmax = Cmax at steady state (ss) divided by Cmax at first dose.
|
Day 10
|
Observed Accumulation Ratio for AUCτau (Rac, AUCτau)
Time Frame: Day 10
|
Accumulation ratio calculated as, Rac obtained from Area Under the Concentration Time Curve (AUCτau) from time 0-τau (Day 10) divided by AUC from time 0-τau (Day 1).
|
Day 10
|
Multiple Dose PK half-life (t½)
Time Frame: Day 10
|
Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.
|
Day 10
|
Apparent Volume of Distribution (Vz/F)
Time Frame: Day 10
|
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
|
Day 10
|
Apparent Oral Clearance (CL/F)
Time Frame: Day 10
|
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed and a quantitative measure of the rate at which the drug is removed from the blood.
|
Day 10
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C4711001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on PF-07295324
-
PfizerCompleted
-
University of FloridaCompletedGastrointestinal Symptoms | Stool Frequency | Gastrointestinal Transit TimeUnited States
-
PfizerCompleted
-
PfizerCompletedSchizophreniaUnited States
-
PfizerCompleted
-
PfizerCompleted
-
PfizerActive, not recruitingNonalcoholic Fatty Liver Disease | Nonalcoholic Steatohepatitis With Liver FibrosisHong Kong, United States, Taiwan, Puerto Rico, China, Canada, Korea, Republic of, Bulgaria, Japan, India, Poland, Slovakia
-
PfizerCompletedHealthy ParticipantsUnited States
-
PfizerCompletedDiabetes Mellitus, Type 1United States