Study to Evaluate Safety and Tolerability of PF-07242813 in Healthy Participants and Participants With Atopic Dermatitis
NCT04668066
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Part 1 (Healthy Volunteer Cohorts):
- BMI of 17.5 to 30.5 kg/m2; and BW>50 kg (110 lbs)
- Overtly healthy as determined by medical evaluation including medical history, physical examination, vital sign assessments, temperature, 12-lead ECGs, laboratory tests
- Japanese cohort: healthy adults of Japanese descent, where parents and grandparents are Japanese
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol
Part 2 (Atopic Dermatitis Cohort):
- Evidence of active, latent, or inadequately treated TB.
- History of or positive result for HIV or hepatitis infection. Positive Covid-19 test
(if collected).
- Significant medical or psychiatric condition, including suicidal ideation (C-SSRS
screening assessment noting suicidal ideation in prior 6 months is not eligible).
- H/o or current endocrine disease.
- History of systemic infection requiring hospitalization, parenteral antimicrobial
treatment or considered significant by Investigator.
- History of or current malignancy, with the exception of non-metastatic BCC, squamous
cell skin or cervical in situ.
- Currently have active forms of other inflammatory skin diseases.
- Have history of or current evidence of skin disease at the time of Day 1 that would
interfere with evaluation of atopic dermatitis or response to treatment.
- Have active chronic or acute skin infection requiring treatment with systemic
antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks
prior to Day 1, or superficial skin infections within 1 week prior to Day 1.
- Score of >5 on the Fitzpatrick Skin Type Assessment.
- History of anaphylaxis with the exception of participants with sensitivity and/or
anaphylaxis only to a single, avoidable allergen.
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Descriptive Information | |||||
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Brief Title ICMJE | Study to Evaluate Safety and Tolerability of PF-07242813 in Healthy Participants and Participants With Atopic Dermatitis | ||||
Official Title ICMJE | A PHASE 1 FIRST IN HUMAN, RANDOMIZED, DOUBLE BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE DOSE ESCALATION, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF 07242813 IN HEALTHY PARTICIPANTS AND PARTICIPANTS WITH ATOPIC DERMATITIS | ||||
Brief Summary | This is the first time PF-07242813 will be given to humans. The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07242813 in healthy participants and in participants with moderate to severe atopic dermatitis. An additional goal is to assess the pharmacodynamics of PF-07242813 in participants with moderate to severe AD, including potential effects on clinical signs and symptoms. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Basic Science | ||||
Condition ICMJE | Atopic Dermatitis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 146 | ||||
Original Estimated Enrollment ICMJE | 145 | ||||
Estimated Study Completion Date ICMJE | November 16, 2021 | ||||
Estimated Primary Completion Date | November 16, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria Part 1 (Healthy Volunteer Cohorts):
Inclusion Criteria Part 2 (Atopic Dermatitis Cohort):
Exclusion Criteria Part 1 (Healthy Volunteer Cohorts):
Exclusion Criteria Part 2 (Atopic Dermatitis Cohort):
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04668066 | ||||
Other Study ID Numbers ICMJE | C4461001 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |