A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
NCT ID: NCT01844804
Last Updated: 2014-01-07
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
146 participants
INTERVENTIONAL
2013-05-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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A = PF-06438179
PF-06438179
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
B = Infliximab-EU
Remicade
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
C = Infliximab-US
Remicade
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Interventions
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PF-06438179
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Remicade
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Remicade
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight \>50kg (110 lbs).
Exclusion Criteria
* Previous exposure to a monoclonal antibody, or current use of other biologics.
* History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs.
* History of tuberculosis (TB) or a positive latent TB test at Screening.
18 Years
55 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 Investigational Site
Overland Park, Kansas, United States
Countries
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References
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Palaparthy R, Udata C, Hua SY, Yin D, Cai CH, Salts S, Rehman MI, McClellan J, Meng X. A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade(R) (infliximab) in healthy subjects (REFLECTIONS B537-01). Expert Rev Clin Immunol. 2018 Apr;14(4):329-336. doi: 10.1080/1744666X.2018.1446829. Epub 2018 Mar 12.
Related Links
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Other Identifiers
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REFLECTIONS B537-01
Identifier Type: -
Identifier Source: secondary_id
B5371001
Identifier Type: -
Identifier Source: org_study_id
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