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A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347

Last updated on March 25, 2019

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Idiopathic Thrombocytopenic Purpura
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy male participants who, at the time of screening, are between the ages of 18
and 40 years, inclusive. Healthy is defined as no clinically relevant abnormalities
identified by a detailed medical history, full physical examination, including oral
temperature, blood pressure (BP) and pulse rate measurement, pulse oximetry, 12 lead
ECG or clinical laboratory tests.

- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.

- Chest X ray with no evidence of current, active tuberculosis (TB) or previous inactive
TB, general infections, heart failure, malignancy, or other clinically significant
abnormalities taken at Screening or within 3 months prior to Screening and read by a
qualified radiologist.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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 the time of dosing).

- Participants with a history of autoimmune disorders and other conditions that
compromise or impair the immune system (including but not limited to: Crohns Disease,
rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Graves disease, and
asthma) or have a current positive result for the following; rheumatoid factor,
anti-nuclear antibody, or abnormal free triiodothyronine (T3), free thyroxine (T4),
thyroid stimulating hormone (TSH), or thyroid stimulating antibody (TSAb) suggestive
of thyroid disease.

Subjects with a history of allergic or anaphylactic reaction to any drug including
immunoglobulin

- History of active infections within 28 days prior to the screening visit

- Subjects with a history of or current positive results for any of the following
serological tests: Hepatitis B surface antigen (HepBsAg), Hepatitis B core antibody
(HepBcAb), Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).

- Subjects with a history of thromboembolic events or current positive result for
anti-cardiolipin antibody

- History of TB or active, latent or inadequately treated TB infection. All positive TB
test result(s) are exclusionary

- Male subjects with partners currently pregnant; male subjects able to father children
who are unwilling or unable to use a highly effective method of contraception as
outlined in this protocol for the duration of the study.

NCT03275740
Pfizer
Recruiting
A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Idiopathic Thrombocytopenic Purpura
NCT03275740
Males
18+
Years
Brussels,

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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