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Singe Dose Study of PF- 06946860 in Healthy Adult Japanese Participants

Last updated on June 7, 2019

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Study Location
Anaheim Clinical Trials
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy female subjects of nonchildbearing potential and/or male subjects who, at the
time of screening, are between the ages of 18 and 55 years, inclusive

- Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
lb)

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

- Subjects enrolling as Japanese must have four biologically Japanese grandparents born
in Japan.

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, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing.

- History of allergic reactions to diagnostic or therapeutic protein or human albumin.

- History of recurrent infections or active infection within 28 days of screening.

- Exposure to live vaccines within 28 days of screening.

- History of regular alcohol consumption or positive drug test

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half lives preceding the first dose of IP (whichever is longer).

- Fertile male subjects who are unwilling or unable to use a highly effective method of
contraception for the duration of the study and for at least 28 days after the last
dose.

- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose

NCT03974776
Pfizer
Not yet recruiting
Singe Dose Study of PF- 06946860 in Healthy Adult Japanese Participants

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Pfizer Clinical Trials Contact Center

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[email protected]

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Pfizer Clinical Trials Contact Center

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