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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03210961
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Peter Winkle, MDPfizer CT.gov Call Center
Principal Investigator Affiliation Anaheim Clinical TrialsPfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Plaque Psoriasis
Study Website: View Trial Website

Contact a Trial Team

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Anaheim Clinical Trials, LLC, Anaheim, California

Status

Recruiting

Address

Anaheim Clinical Trials, LLC

Anaheim, California, 92801

Site Contact

1-800-718-1021

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