Single Dose Study of PF-05230907 in Healthy Japanese Subjects
NCT ID: NCT02537002
Last Updated: 2016-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2015-09-30
2016-03-31
Brief Summary
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* To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
* To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
* To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
* To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Cohort 1- PF-05230907 or Placebo
PF-05230907
A single intravenous dose of 3 μg/kg
Placebo
A single intravenous dose of matched placebo
Cohort 2- PF-05230907 or Placebo
PF-05230907
A single intravenous dose of 5 μg/kg
Placebo
A single intravenous dose of matched placebo
Interventions
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PF-05230907
A single intravenous dose of 3 μg/kg
PF-05230907
A single intravenous dose of 5 μg/kg
Placebo
A single intravenous dose of matched placebo
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs) and \<120 kg (265 lbs).
* Japanese subjects who have four biologic Japanese grandparents born in Japan.
Exclusion Criteria
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
18 Years
45 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
Countries
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Related Links
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Other Identifiers
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B2341003
Identifier Type: -
Identifier Source: org_study_id