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Monoclonal Antibodies

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

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1,15,29(pre-dose,2,6,12,24,48,72,96 hours post-dose) day 15,29(168hours post-dose) day 29(336,672,1008,1344,1680hours post-dose) (for all cohorts); day 1(168hours post-dose for all except 15mg and 50 mg post-dose)

Summary

This trial is testing a new drug called PF-07242813 for the first time in humans. It aims to check if the drug is safe and how it behaves in the body. The study includes both healthy people and those with moderate to severe atopic dermatitis to see if it can help reduce their symptoms.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1,15,29(pre-dose,2,6,12,24,48,72,96 hours post-dose) day 15,29(168hours post-dose) day 29(336,672,1008,1344,1680hours post-dose) (for all cohorts); day 1(168hours post-dose for all except 15mg and 50 mg post-dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1,15,29(pre-dose,2,6,12,24,48,72,96 hours post-dose) day 15,29(168hours post-dose) day 29(336,672,1008,1344,1680hours post-dose) (for all cohorts); day 1(168hours post-dose for all except 15mg and 50 mg post-dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: MAD Cohorts: Number of Participants With Clinically Significant Findings in ECG
Part 1: MAD Cohorts: Number of Participants With Clinically Significant Findings in Vital Signs
Part 1: MAD Cohorts: Number of Participants With Laboratory Test Abnormalities
+10 more
Secondary study objectives
Part 1: MAD Cohorts: Area Under the Serum Concentration Time Profile Over the Dosing Interval (AUCtau) for PF-07242813
Part 1: MAD Cohorts: Terminal Elimination Half Life (t1/2) for PF-07242813
Part 1: SAD Cohorts: Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for PF-07242813
+3 more

Side effects data

From 2022 Phase 1 trial • 121 Patients • NCT04668066
25%
Rash papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2: Placebo IV AD
Part 1: 1000 mg IV SAD (Japanese Cohort)
Part 1: 3 mg IV SAD
Part 1: 1000 mg IV SAD
Part 1: 1mg IV SAD
Part 1: 0.3 mg IV SAD
Part 1: Placebo IV MAD
Part 1: 10 mg IV SAD
Part 1: 50 mg SC Q2W MAD
Part 1: 150 mg SC Q2W MAD
Part 1: 300 mg SC Q2W MAD
Part 1: Placebo SC MAD
Part 1: 30 mg IV SAD
Part 1: 100 mg IV SAD
Part 1: 300 mg IV SAD
Part 2: 1000 mg IV AD
Part 1: 15 mg SC Q2W MAD
Part 1: 500 mg IV Q2W MAD
Part 1: Placebo SAD

Trial Design

3Treatment groups
Experimental Treatment
Group I: Single dose of PF-07242813 or placebo in participants with moderate to severe atopic dermatitisExperimental Treatment2 Interventions
Participants will receive a single intravenous dose of either PF-07242813 or placebo
Group II: Single ascending doses of PF-07242813 or placebo in healthy participantsExperimental Treatment2 Interventions
Participants will receive a single intravenous dose of either PF-07242813 or placebo
Group III: Multiple ascending doses of PF-07242813 or placebo in healthy participantsExperimental Treatment2 Interventions
Participants will receive multiple subcutaneous doses PF-07242813 or placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07242813
2020
Completed Phase 1
~130
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,669 Previous Clinical Trials
17,861,803 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,805 Total Patients Enrolled
~24 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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