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
Pfizer
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. 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
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…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion 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: 1. Have a clinical diagnos…
Interventions
- DrugPF-07832837
escalated doses of PF-07832837
- OtherPlacebo
placebo
Locations (3)
- Anaheim Clinical Trials, LLCAnaheim, California
- Miami Dermatology and Laser ResearchMiami, Florida
- Paddington Testing CompanyPhiladelphia, Pennsylvania