A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis

• Status: Completed
• Trial end date: 2019-01-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Pharmaceutical Solutions

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