Trials Sponsors Conditions Drugs Pricing

Conditions

Atopic Dermatitis Healthy Participants

Keywords

healthyatopic dermatitisfirst in humanmonoclonal antibodyanti-inflammatorypharmacokineticspharmacodynamics

Outcome Measures

Primary Outcomes (11)

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.
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.
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.

Secondary Outcomes (9)

Area Under the Curve From Time Zero to Last (AUClast) of PF-07832837 following SAD
Day 1 to Day 35
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07832837 following SAD
Day 1 to Day 35
Maximum Observed Serum Concentration (Cmax) of PF-07832837 following SAD
Day 1 to Day 35
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07832837 following SAD
Day 1 to Day 35
Terminal serum elimination half life (t1/2) of PF-07832837 following SAD
Day 1 to Day 35
+4 more secondary outcomes

Study Arms (2)

PF-07832837

EXPERIMENTAL

single or multiple doses of PF-07832837 at ascending dose levels

Drug: PF-07832837

placebo

PLACEBO COMPARATOR

single or multiple doses of placebo

Other: Placebo

Interventions

PF-07832837Drug

escalated doses of PF-07832837

PF-07832837

PlaceboOther

placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Pfizer Inc.
Industrylead
Pfizer
Industrylead

Study Sites (5)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

RECRUITING

TCR Medical Corporation

San Diego, California, 92123, United States

RECRUITING

Miami Dermatology and Laser Research

Miami, Florida, 33133, United States

RECRUITING

Revival Research Institute, LLC

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

November 5, 2024

Actual (reported)

Primary Completion

June 2, 2027

Estimated

You may not qualify if:

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.
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).

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (11)

Secondary Outcomes (9)

Study Arms (2)

PF-07832837

placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (11)

Secondary Outcomes (9)

Study Arms (2)

PF-07832837

placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations