A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: PF-06826647 tablet; PF-06826647 oral suspension; Placebo oral solution/suspension; Placebo tablet
Intervention description: PF-06826647 tablet for oral administration; PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only); placebo oral solution for the single ascending dose, first cohort only; Matching placebo tablet
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Combination single and multiple ascending dose design. Cohorts of participants are assigned to receive interventions based on acceptable safety, tolerability, and pharmacokinetics of previous dose cohort
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind treatment
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.
    

Eligibility criteria:

        Healthy Participants:

        Inclusion Criteria:

          -  Healthy male subjects between ages of 18-55 years

          -  Healthy female subjects of non-childbearing potential between the ages of 18-55 years

          -  Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs).

          -  No evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis (TB)

          -  (Optional) Japanese subjects who have four Japanese biologic grandparents born in
             Japan

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing)

          -  Pregnant female subjects; breastfeeding female subjects; female subjects of
             childbearing potential

          -  Fertile male subjects who are unwilling or unable to use a highly effective method of
             contraception as outlined in this protocol for the duration of the study and for at
             least 28 days after the last dose of investigational product

          -  Have a clinically significant infection currently or within 6 months of first dose of
             study drug

        Psoriasis Participants:

        Inclusion Criteria:

          -  Healthy male subjects between ages of 18-65 years

          -  Healthy female subjects of non-childbearing potential between the ages of 18-65 years

          -  Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose

          -  Have plaque-type psoriasis covering at least 15% of total body surface area (BSA) at
             Day-1(prior to randomization in the study

          -  No evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis (TB)

        Exclusion Criteria:

          -  Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular
             psoriasis

          -  Have a clinically significant infection currently or within 6 months of first dose of
             study drug, or a history of chronic or recurrent infectious disease

          -  Pregnant female subjects; breastfeeding female subjects; female subjects of
             childbearing potential

          -  Fertile male subjects who are unwilling or unable to use a highly effective method of
             contraception as outlined in this protocol for the duration of the study and for at
             least 28 days after the last dose of investigational product