Study to Evaluate Safety and Tolerability of PF-07242813 in Healthy Participants and Participants With Atopic Dermatitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2022-12-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants

NCT04135560

Dermatitis Atopic

COMPLETED PHASE1

FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients

NCT06564389

Healthy Participants Atopic Dermatitis

RECRUITING PHASE1

A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema

NCT07216027

Atopic Dermatitis Eczema, Atopic

RECRUITING PHASE2

Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

NCT02780167

Atopic Dermatitis

COMPLETED PHASE2

Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis

NCT03915496

Atopic Dermatitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single ascending doses of PF-07242813 or placebo in healthy participants

Participants will receive a single intravenous dose of either PF-07242813 or placebo

Group Type EXPERIMENTAL

PF-07242813

Intervention Type DRUG

PF-07242813 given intravenously or subcutaneous

Placebo

Intervention Type DRUG

Placebo given intravenously or subcutaneous

Multiple ascending doses of PF-07242813 or placebo in healthy participants

Participants will receive multiple subcutaneous doses PF-07242813 or placebo

Group Type EXPERIMENTAL

PF-07242813

Intervention Type DRUG

PF-07242813 given intravenously or subcutaneous

Placebo

Intervention Type DRUG

Placebo given intravenously or subcutaneous

Single dose of PF-07242813 or placebo in participants with moderate to severe atopic dermatitis

Participants will receive a single intravenous dose of either PF-07242813 or placebo

Group Type EXPERIMENTAL

PF-07242813

Intervention Type DRUG

PF-07242813 given intravenously or subcutaneous

Placebo

Intervention Type DRUG

Placebo given intravenously or subcutaneous

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-07242813

PF-07242813 given intravenously or subcutaneous

Intervention Type DRUG

Placebo

Placebo given intravenously or subcutaneous

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for approximately 1 year prior to Day 1 and have the diagnosis of AD confirmed (Hanifin and Rajka criteria of AD).
* Either have had an inadequate response to treatment with topical medications (for at least 4 consecutive weeks within 1 year of the first dose of the study drug) OR Have a documented reason why topical treatments are considered medically inappropriate (eg, because of important side effects or safety risks) within the last year.
* Have moderate to severe AD (defined as having an affected BSA (captured as part of EASI) ≥10%, IGA ≥3, and EASI ≥12 at both the screening and baseline visits).
* Generally healthy adult, with no significant comorbidities.
* Mild or moderate asthma that is well-controlled (not requiring high dose inhaled corticosteroids, systemic \[oral or parenteral\] corticosteroids, or biologic asthma treatments).
* BMI of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

* Evidence of active, latent, or inadequately treated infection with TB; History of HIV, hepatitis B or C infection; positive testing for HIV, HepB, HepC except HepB vaccination
* Medical or psychiatric condition that may increase the risk of study participation, or inappropriate for the study in investigator's judgement
* History of any lymphoproliferative disorder, evidence or history of clinically significant diseases
* History of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or judged clinically significant by the investigator within 6 months
* Known history of or evidence of current endocrine disease
* Exposure to live or attenuated vaccines within 28 days of screening.
* Have any malignancies or a history of malignancies except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
* Allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Have undergone significant trauma or major surgery within 1 month of 1st dose of study drug.
* Use of prescription or nonprescription drugs, dietary or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to 1st dose of study drug.
* Females taking hormone replacement therapy may be eligible to participate in this study if they are willing to discontinue therapy at least 28 days prior to the first dose of study treatment and remain off hormonal therapy for the duration of the study.
* Positive urine drug test, alcohol intake more than 14 units per week or use of tobacco/nicotine containing products more than 5 cigarettes per day.
* Treatment with an investigational drug within 28 days or 5 half-lives preceding the first dose of study treatment (whichever is longer).
* Abnormal BP, ECG and lab tests including AST/ALT, total bilirubin and anterior pituitary hormones, at screenings and/or baseline, based on pre-specified criteria per protocol.
* Unwilling or unable to comply with the Lifestyle guidance specified in this protocol (Lifestyle Considerations section).

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes