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

Phase 1

Not yet recruiting

• Conditions: Healthy Participants; Atopic Dermatitis

• Registration Number: NCT06564389
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

Inclusion Criteria:<br><br> - Part 1 only: Adult participants between 18 to 55 years of age, inclusive, at the<br> time of signing the Informed Consent Document (ICD)<br><br> - Part 2 only: Adult participants, who at the time of screening, are between the ages<br> of 18 and 70 years, inclusive. Participants above 65 years need to be discussed with<br> the sponsor.<br><br> - Part 1 only: Participants who are overtly healthy as determined by medical<br> evaluation including medical history, physical examination, vital sign assessments,<br> temperature, 12-lead ECGs, laboratory tests<br><br> - BMI of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lbs)<br><br> - Part 2 only: Must meet the following AD criteria:<br><br> 1. Have a clinical diagnosis of chronic AD (also known as atopic eczema) for<br> approximately 1 year prior to Day 1 and have the diagnosis of AD confirmed<br> (Section 10.9 Appendix 9: Diagnostic Criteria for Atopic Dermatitis).<br><br> 2. Either have had an inadequate response to treatment with topical medications<br> (for at least 4 consecutive weeks within 1 year of the first dose of the study<br> intervention). OR Have a documented reason why topical treatments are<br> considered medically inappropriate (eg, because of important side effects or<br> safety risks) within the last year.<br><br> 3. Have moderate to severe AD (defined as having an affected BSA (captured as part<br> of EASI) =10%, Investigator's Global Assessment (IGA) =3, and EASI =12 at both<br> the screening and baseline visits).<br><br> 4. Have an otherwise healthy medical evaluation (other than signs and symptoms of<br> AD) including medical history, physical examination, vital sign assessments,<br> temperature, 12-lead ECGs, laboratory tests. Note: Controlled comorbid diseases<br> (ie, controlled diabetes not requiring insulin, controlled hypertension), are<br> acceptable, so long as they do not require administration of prohibited<br> medications.<br><br>Mild or moderate asthma that is well-controlled (not requiring high dose inhaled<br>corticosteroids, systemic [oral or parenteral] corticosteroids, or biologic asthma<br>treatments).<br><br>Exclusion Criteria:<br><br> - Have a history of systemic infection requiring hospitalization and parenteral<br> antimicrobial therapy, any lymphoproliferative disorder, malignancies.<br><br> - Evidence or history of clinically significant hematological, renal, endocrine,<br> pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,<br> immunological/rheumatological disorder.<br><br> - Have undergone significant trauma or major surgery within 1 month of the first dose<br> of study intervention.<br><br> - Evidence of active, latent, or inadequately treated infection with Mycobacterium<br> tuberculosis (TB) as defined by both of the following:<br><br> 1. A positive QuantiFERON-TB Gold In-tube or equivalent test.<br><br> 2. History of either untreated or inadequately treated latent or active TB<br> infection, or current treatment for the same.<br><br>part 2 Only<br><br> - Currently have active forms of other inflammatory skin diseases<br><br> - Have history of or current evidence of skin conditions (eg, psoriasis, seborrheic<br> dermatitis, lupus) at the time of Day 1 that would interfere with evaluation of<br> atopic dermatitis or response to treatment. Have active chronic or acute skin<br> infection requiring treatment with systemic antibiotics, antivirals, antiparasitics,<br> antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin<br> infections within 1 week prior to Day 1. NOTE: potential participants may be<br> rescreened after infection resolves.<br><br> - Score of >5 on the Fitzpatrick Skin Type Assessment.<br><br> - History of anaphylaxis with the following exceptions: participants with sensitivity<br> and/or anaphylaxis only to a single, avoidable allergen (eg, aspirin, penicillin,<br> sulfa drugs, nonsteroidal anti-inflammatory drugs [NSAIDs], peanuts) may be<br> enrolled, if in the opinion of the investigator, the participant is aware of the<br> hypersensitivity and avoids the problematic allergen. Participants must carry<br> appropriate treatment for anaphylaxis and must know how to manage anaphylactic<br> reactions.<br><br> - Any investigational or experimental therapy taken or procedure performed for AD,<br> psoriasis, psoriatic arthritis, rheumatoid arthritis or other inflammatory diseases<br> in the previous 1 year should be discussed with the Pfizer Medical Monitor (or<br> designee).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified