Healthy ParticipantsPhase 1NCT06564389
FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
A Phase 1 study testing PF-07832837 in people with Healthy Participants and Atopic Dermatitis, run by Pfizer at 8 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Atopic Dermatitis
- What is being tested?
- PF-07832837
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 5 Nov 2024to 2 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1 only: Adult participants between 18 to 55 years of age, inclusive, at the time of signing the ICD
- Part 2 only: Adult participants, who at the time of screening, are between the ages of 18 and 70 years, inclusive.
- Part 1 only: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital sign assessments, temperature, 12-lead ECGs, laboratory tests
- BMI of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lbs)
- Part 2 only: Must meet the following AD criteria:
- Have a clinical diagnosis of chronic AD (also known as atopic eczema) for at least 1 year prior to Day 1 and have the diagnosis of AD confirmed by photographs (at screening) and diagnostic criteria for AD.
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- Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) consistent with AD treatment guidelines (for at least 4 consecutive weeks within 6 to 12 months (depending on time since initial diagnosis) of the first dose of the study intervention. OR Have a documented reason why topical treatments are considered medically inappropriate 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).
- Have an otherwise healthy medical evaluation (other than signs and symptoms of AD) including medical history, physical examination, vital sign assessments, temperature, 12-lead ECGs, laboratory tests.
- Controlled comorbid diseases are acceptable so long as they do not require administration of prohibited medications. This includes participants with mild or moderate asthma that is well-controlled (not requiring high dose inhaled corticosteroids, systemic [oral or parenteral] corticosteroids, or biologic asthma treatments).
Who cannot join
- Have a history of systemic infection requiring hospitalization and parenteral antimicrobial therapy, any lymphoproliferative disorder, malignancies.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, immunological/rheumatological disorder.
- Have undergone significant trauma or major surgery within 1 month of the first dose of study intervention.
- Evidence of active, 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.
- History of either untreated or inadequately treated latent or active TB infection, or current treatment for the same.
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- Part 2 Only
- Currently have active forms of other inflammatory skin diseases
- Have history of or current evidence of skin conditions 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 following exceptions: participants with sensitivity and/or anaphylaxis only to a single, avoidable allergen (eg, aspirin, penicillin, sulfa drugs, nonsteroidal anti-inflammatory drugs [NSAIDs], peanuts) may be enrolled, if in the opinion of the investigator, the participant is aware of the hypersensitivity and avoids the problematic allergen. Participants must carry appropriate treatment for anaphylaxis and must know how to manage anaphylactic reactions.
- Any investigational or experimental therapy taken or procedure performed for AD, psoriasis, psoriatic arthritis, rheumatoid arthritis or other inflammatory diseases in the previous 1 year should be discussed with the Pfizer Medical Monitor (or designee).
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
- Recruiting
Miami Dermatology and Laser Research
Miami, Florida, 33133
- Recruiting
Paddington Testing Company
Philadelphia, Pennsylvania, 19103
- Recruiting
TCR Medical Corporation
San Diego, California, 92123
- Recruiting
Revival Research Institute, LLC
Troy, Michigan, 48084
Poland3 sites, 3 recruiting
- Not yet recruiting
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611
- Not yet recruiting
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, 90-436
- Not yet recruiting
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki
Szczecin, West Pomeranian Voivodeship, 70-332
About this study
Official title: A PHASE 1, FIRST IN HUMAN, RANDOMIZED, DOUBLE-BLIND, SPONSOROPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE DOSE ESCALATION, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07832837 IN HEALTHY PARTICIPANTS AND PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis. An additional goal is to assess the pharmacodynamics of PF-07832837 in participants with moderate to severe AD, including potential effects on clinical signs and symptoms
Read the detailed description
This is a first-in-human (FIH) study of PF-07832837 that will be conducted in 2 parts: Part 1 will be conducted in healthy adult participants and Part 2 will be conducted in adult participants with moderate to severe AD.
Part 1 is within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled investigation of the safety, tolerability, PK, and immunogenicity following single and multiple ascending doses of PF-07832837 in healthy participants. Part 1 may also include a cohort of Japanese healthy adult participants to provide safety, tolerability, and PK data in Japanese population to enable the inclusion of Japanese participants in future clinical trials.
Part 2 is a randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study to investigate the safety, tolerability, PK, and pharmacodynamics (including clinical effects) of PF-07832837 in participants with moderate to severe AD. Part 2 will consist of cohorts of participants with moderate to severe AD. A total of approximately 28 participants will receive either active PF-07832837 or placebo.
- Conditions
- Healthy Participants, Atopic Dermatitis
- Being tested
- PF-07832837, Placebo
- Keywords
- healthy, atopic dermatitis, first in human, monoclonal antibody, anti-inflammatory, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07832837Drug
escalated doses of PF-07832837
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| PF-07832837 | Experimental | single or multiple doses of PF-07832837 at ascending dose levels Receives: Drug: PF-07832837 |
| placebo | Placebo comparator | single or multiple doses of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and serious adverse events (SAEs) Following single ascending doses (SAD)
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.
Measured: Baseline up to Day 35
Number of Participants with Clinically significant Laboratory Abnormalities Following SAD
Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.
Measured: Baseline up to Day 35
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following SAD
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. Clinically significant findings were determined by the investigator.
Measured: Baseline up to Day 35
Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following SAD
Vital signs included blood pressure, pulse rate, respiratory rate, oxygen saturation and oral temperature. Clinically significant findings were determined by the investigator.
Measured: Baseline up to Day 35
Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings Following SAD
Cardiac telemetry was collected in Part 1 SAD cohorts only. Number of participants with any cardiac telemetry abnormalities were reported in this outcome measure.
Measured: Day 1
Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs Following multiple ascending doses (MAD)
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.
Measured: Baseline up to Day 50
Number of Participants with Clinically significant Laboratory Abnormalities Following MAD
Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.
Measured: Baseline up to Day 50
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following MAD
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. Clinically significant findings were determined by the investigator.
Measured: Baseline up to Day 50
Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs in participants with atopic dermatitis (AD)
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.
Measured: Baseline up to Day 80
Number of Participants with Clinically significant Laboratory Abnormalities in participants with AD
Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.
Measured: Baseline up to Day 80
Number of Participants with Clinically Significant Change from Baseline in Vital Signs in participants with AD
Vital signs included blood pressure, pulse rate, respiratory rate, oxygen saturation and oral temperature. Clinically significant findings were determined by the investigator.
Measured: Baseline up to Day 78
Secondary outcomes (9)
Area Under the Curve From Time Zero to Last (AUClast) of PF-07832837 following SAD
estimated by Linear/Log trapezoidal method
Measured: Day 1 to Day 35
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07832837 following SAD
AUClast + (Clast*/kel), where Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis
Measured: Day 1 to Day 35
Maximum Observed Serum Concentration (Cmax) of PF-07832837 following SAD
Observed directly from data
Measured: Day 1 to Day 35
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07832837 following SAD
Observed directly from data as time of first occurrence
Measured: Day 1 to Day 35
Terminal serum elimination half life (t1/2) of PF-07832837 following SAD
Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration time curve. Only those data points judged to describe the terminal log-linear decline will be used in the regression
Measured: Day 1 to Day 35
Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of PF-07832837 following MAD
Linear/log trapezoidal method
Measured: Day 1 to Day 22
Maximum Observed Serum Concentration (Cmax) of PF-07832837 following MAD
Observed directly from data
Measured: Day 1 to Day 22
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07832837 following MAD
Observed directly from data as the time of first occurrence
Measured: Day 1 to Day 22
Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 8
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start5 Nov 2024
- Primary completion2 Jun 2027 (estimated)
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564389
- Sponsor's protocol ID
- C4991001
- Other IDs
- NCT06564389
- Status last verified
- Nov 2026
- First submitted
- 19 Aug 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, FIRST IN HUMAN, RANDOMIZED, DOUBLE-BLIND, SPONSOROPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE DOSE ESCALATION, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07832837 IN HEALTHY PARTICIPANTS AND PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
- ClinicalTrials.gov ID
- NCT06564389
- Acronym / sponsor ID
- C4991001
- Conditions
- Healthy Participants, Atopic Dermatitis
- Keywords
- healthy, atopic dermatitis, first in human, monoclonal antibody, anti-inflammatory, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 2 Jun 2027 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis. An additional goal is to assess the pharmacodynamics of PF-07832837 in participants with moderate to severe AD, including potential effects on clinical signs and symptoms
Detailed description
This is a first-in-human (FIH) study of PF-07832837 that will be conducted in 2 parts: Part 1 will be conducted in healthy adult participants and Part 2 will be conducted in adult participants with moderate to severe AD.
Part 1 is within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled investigation of the safety, tolerability, PK, and immunogenicity following single and multiple ascending doses of PF-07832837 in healthy participants. Part 1 may also include a cohort of Japanese healthy adult participants to provide safety, tolerability, and PK data in Japanese population to enable the inclusion of Japanese participants in future clinical trials.
Part 2 is a randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study to investigate the safety, tolerability, PK, and pharmacodynamics (including clinical effects) of PF-07832837 in participants with moderate to severe AD. Part 2 will consist of cohorts of participants with moderate to severe AD. A total of approximately 28 participants will receive either active PF-07832837 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-07832837 | Experimental | Drug: PF-07832837single or multiple doses of PF-07832837 at ascending dose levels |
| placebo | Placebo comparator | Other: Placebosingle or multiple doses of placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Part 1 only: Adult participants between 18 to 55 years of age, inclusive, at the time of signing the ICD
- Part 2 only: Adult participants, who at the time of screening, are between the ages of 18 and 70 years, inclusive.
- Part 1 only: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital sign assessments, temperature, 12-lead ECGs, laboratory tests
- BMI of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lbs)
- Part 2 only: Must meet the following AD criteria:
Key exclusion criteria (12 listed)
- Have a history of systemic infection requiring hospitalization and parenteral antimicrobial therapy, any lymphoproliferative disorder, malignancies.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, immunological/rheumatological disorder.
- Have undergone significant trauma or major surgery within 1 month of the first dose of study intervention.
- Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following:
- Part 2 Only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07832837escalated doses of PF-07832837 | Drug | PF-07832837 |
| Placeboplacebo | Other | placebo |
Primary outcome
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and serious adverse events (SAEs) Following single ascending doses (SAD)
Time frame: Baseline up to Day 35
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.
Number of Participants with Clinically significant Laboratory Abnormalities Following SAD
Time frame: Baseline up to Day 35
Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following SAD
Time frame: Baseline up to Day 35
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. Clinically significant findings were determined by the investigator.
Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following SAD
Time frame: Baseline up to Day 35
Vital signs included blood pressure, pulse rate, respiratory rate, oxygen saturation and oral temperature. Clinically significant findings were determined by the investigator.
Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings Following SAD
Time frame: Day 1
Cardiac telemetry was collected in Part 1 SAD cohorts only. Number of participants with any cardiac telemetry abnormalities were reported in this outcome measure.
Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs Following multiple ascending doses (MAD)
Time frame: Baseline up to Day 50
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.
Number of Participants with Clinically significant Laboratory Abnormalities Following MAD
Time frame: Baseline up to Day 50
Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following MAD
Time frame: Baseline up to Day 50
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. Clinically significant findings were determined by the investigator.
Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs in participants with atopic dermatitis (AD)
Time frame: Baseline up to Day 80
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.
Number of Participants with Clinically significant Laboratory Abnormalities in participants with AD
Time frame: Baseline up to Day 80
Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.
Number of Participants with Clinically Significant Change from Baseline in Vital Signs in participants with AD
Time frame: Baseline up to Day 78
Vital signs included blood pressure, pulse rate, respiratory rate, oxygen saturation and oral temperature. Clinically significant findings were determined by the investigator.
9 secondary outcomes
Area Under the Curve From Time Zero to Last (AUClast) of PF-07832837 following SAD
Time frame: Day 1 to Day 35
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07832837 following SAD
Time frame: Day 1 to Day 35
Maximum Observed Serum Concentration (Cmax) of PF-07832837 following SAD
Time frame: Day 1 to Day 35
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07832837 following SAD
Time frame: Day 1 to Day 35
Terminal serum elimination half life (t1/2) of PF-07832837 following SAD
Time frame: Day 1 to Day 35
Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of PF-07832837 following MAD
Time frame: Day 1 to Day 22
Maximum Observed Serum Concentration (Cmax) of PF-07832837 following MAD
Time frame: Day 1 to Day 22
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07832837 following MAD
Time frame: Day 1 to Day 22
Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 8
Time frame: Baseline, Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07832837 in people with Healthy Participants and Atopic Dermatitis, run by Pfizer at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and serious adverse events (SAEs) Following single ascending doses (SAD) (time frame: Baseline up to Day 35). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.