A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
Completed · Phase 1 · Has a placebo group
Conditions studied: Plaque Psoriasis
In brief
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.
Key facts
- Study ID
- NCT03210961
- Run by
- Pfizer
- People needed
- 109
- Starts
- 2017-07-14
- Expected to finish
- 2019-01-25
- Last updated by the study team
- 2020-03-31
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Anaheim Clinical Trials, LLC — Anaheim, California, United States
Full record on ClinicalTrials.gov
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