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New treatment option for Healthy Participants
Official title FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
ClinicalTrials.gov ID: NCT06564389
What this study is testing
What is PF-07832837?
PF-07832837 is an investigational medicine, being studied as a potential treatment for healthy participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join 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.
- Part 1 only: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital sign...
- 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:
You likely can't join 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...
- 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
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Anaheim, California, United States
- Miami, Florida, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anaheim, California, United States; Miami, Florida, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.