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

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ClinicalTrials.gov Identifier: NCT04668066
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 8, 2020
First Posted Date  ICMJE December 16, 2020
Last Update Posted Date December 19, 2020
Actual Study Start Date  ICMJE December 9, 2020
Estimated Primary Completion Date November 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • Incidence of treatment-emergent adverse events (AEs and SAEs). [ Time Frame: Baseline up to Week 16 ]
  • Number of Participants With Clinically Significant Change From Baseline in Safety Laboratory Tests [ Time Frame: Baseline up to Week 16 ]
  • Number of Participants With Clinically Significant Change From Baseline in ECG [ Time Frame: Baseline up to Week 16 ]
  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to Week 16 ]
  • Number of Participants With Clinically Significant Change From Baseline in Cardiac telemetry (SAD only) [ Time Frame: Baseline up to Day 71 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2020)
  • Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: Baseline up to Week 16 ]
  • Number of Participants With Clinically Significant Change From Baseline in Safety Laboratory Tests [ Time Frame: Baseline up to Week 16 ]
  • Number of Participants With Clinically Significant Change From Baseline in ECG [ Time Frame: Baseline up to Week 16 ]
  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to Week 16 ]
  • Number of Participants With Clinically Significant Change From Baseline in Cardiac telemetry (SAD only) [ Time Frame: Baseline up to Day 71 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • Single Dose: AUC from time zero to time of last measurable concentration (AUClast) in the Dose Escalation and Dose Finding Arms [ Time Frame: 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose and Days 15, 29, 43, 57, and 71 ]
    Pharmacokinetic (PK) assessments for PF-07242813
  • Single Dose: AUC from time zero to time to infinity (AUCinf) in the Dose Escalation and Dose Finding Arms [ Time Frame: 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose and Days 15, 29, 43, 57, and 71 ]
    PK assessments for PF-07242813
  • Single Dose: Maximum Observed Concentration (Cmax) in the Dose Escalation and Dose Finding Arms [ Time Frame: 0, 2, 6, 12, 24, 48, 72, 96, hours post-dose and Days 8, 15, 29, 43, 57, and 71 ]
    PK assessments for PF-07242813
  • Single Dose: Tmax time to reach maximum concentration (Tmax) in the Dose Escalation and Dose Finding Arms [ Time Frame: 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose and Days 15, 29, 43, 57, and 71 ]
    PK assessments for PF-07242813
  • Single Dose: Terminal Elimination half-life (t1/2) in the Dose Escalation and Dose Finding Arms [ Time Frame: 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose and Days 15, 29, 43, 57, and 71 ]
    PK assessments for PF-07242813
  • Repeat Dose: AUC from time zero to time curve within dosing interval (AUCtau) in the Dose Esclation and Dose Finding Arms [ Time Frame: Day 1 - 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose; Days 15 and 29 - 0, 2, 6, 8, 12, 24, 48 and 96 hours post-dose; and Days 43, 57, 71, 85 and 99 ]
    PK assessments for PF-07242813
  • Repeat Dose: Cmax in the Dose Esclation and Dose Finding Arms [ Time Frame: Day 1 - 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose; Days 15 and 29 - 0, 2, 6, 8, 12, 24, 48 and 96 hours post-dose; and Days 43, 57, 71, 85 and 99 ]
    PK assessments for PF-07242813
  • Repeat Dose: Tmax in the Dose Escalation and Dose Finding Arms [ Time Frame: Day 1 - 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose; Days 15 and 29 - 0, 2, 6, 8, 12, 24, 48 and 96 hours post-dose; and Days 43, 57, 71, 85 and 99 ]
    PK assessments for PF-07248144
  • Repeat dose: t1/2 in the Dose Escalation and Dose Finding Arms [ Time Frame: Day 1 - 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose; Days 15 and 29 - 0, 2, 6, 8, 12, 24, 48 and 96 hours post-dose; and Days 43, 57, 71, 85 and 99 ]
    PK assessments for PF-07242813
  • Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 6 [ Time Frame: Baseline to Week 6 ]
    Efficacy evaluation for atopic dermatitis cohort.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2020)
  • Single Dose: AUC from time zero to time of last measurable concentration (AUClast) in the Dose Escalation and Dose Finding Arms [ Time Frame: 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose and Days 15, 29, 43, 57, and 71 ]
    Pharmacokinetic (PK) assessments for PF-07242813
  • Single Dose: AUC from time zero to time to infinity (AUCinf) in the Dose Escalation and Dose Finding Arms [ Time Frame: 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose and Days 15, 29, 43, 57, and 71 ]
    PK assessments for PF-07242813
  • Single Dose: Maximum Observed Concentration (Cmax) in the Dose Escalation and Dose Finding Arms [ Time Frame: 0, 2, 6, 12, 24, 48, 72, 96, hours post-dose and Days 8, 15, 29, 43, 57, and 71 ]
    PK assessments for PF-07242813
  • Single Dose: Tmax time to reach maximum concentration (Tmax) in the Dose Escalation and Dose Finding Arms [ Time Frame: 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose and Days 15, 29, 43, 57, and 71 ]
    PK assessments for PF-07242813
  • Single Dose: Terminal Elimination half-life (t1/2) in the Dose Escalation and Dose Finding Arms [ Time Frame: 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose and Days 15, 29, 43, 57, and 71 ]
    PK assessments for PF-07242813
  • Repeat Dose: AUC from time zero to time curve within dosing interval (AUCtau) in the Dose Escalation and Dose Finding Arms [ Time Frame: Day 1 - 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose; Days 15 and 29 - 0, 2, 6, 8, 12, 24, 48 and 96 hours post-dose; and Days 43, 57, 71, 85 and 99 ]
    PK assessments for PF-07242813
  • Repeat Dose: Cmax in the Dose Escalation and Dose Finding Arms [ Time Frame: Day 1 - 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose; Days 15 and 29 - 0, 2, 6, 8, 12, 24, 48 and 96 hours post-dose; and Days 43, 57, 71, 85 and 99 ]
    PK assessments for PF-07242813
  • Repeat Dose: Tmax in the Dose Escalation and Dose Finding Arms [ Time Frame: Day 1 - 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose; Days 15 and 29 - 0, 2, 6, 8, 12, 24, 48 and 96 hours post-dose; and Days 43, 57, 71, 85 and 99 ]
    PK assessments for PF-07248144
  • Repeat dose: t1/2 in the Dose Escalation and Dose Finding Arms [ Time Frame: Day 1 - 0, 2, 6, 12, 24, 48, 72, 96 hours post-dose; Days 15 and 29 - 0, 2, 6, 8, 12, 24, 48 and 96 hours post-dose; and Days 43, 57, 71, 85 and 99 ]
    PK assessments for PF-07242813
  • Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 6 [ Time Frame: Baseline to Week 6 ]
    Efficacy evaluation for atopic dermatitis cohort.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Drug: PF-07242813
    PF-07242813 given intravenously or subcutaneous
  • Drug: Placebo
    Placebo given intravenously or subcutaneous
Study Arms  ICMJE
  • Experimental: Single ascending doses of PF-07242813 or placebo in healthy participants
    Participants will receive a single intravenous dose of either PF-07242813 or placebo
    Interventions:
    • Drug: PF-07242813
    • Drug: Placebo
  • Experimental: Multiple ascending doses of PF-07242813 or placebo in healthy participants
    Participants will receive multiple subcutaneous doses PF-07242813 or placebo
    Interventions:
    • Drug: PF-07242813
    • Drug: Placebo
  • Experimental: 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
    Interventions:
    • Drug: PF-07242813
    • Drug: Placebo
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
 (submitted: December 16, 2020)
146
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2020)
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):

  • 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

Inclusion Criteria Part 2 (Atopic Dermatitis Cohort):

  • 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 Part 1 (Healthy Volunteer Cohorts):

  • 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).

Exclusion Criteria 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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