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Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)

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NCT01870986

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- Healthy male and female (non-childbearing potential). Healthy is defined as no
clinically relevant abnormalities identified by a detailed medical history, full
physical examination including blood pressure, pulse, ECG, and laboratory testing.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant infectious, hematological, renal,
endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric,
neurologic, autoimmune, or allergic disease.

NCT01870986
Pfizer
Completed
Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)

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Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects
This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy
  • Biological: PF-06410293
    40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
    Other Name: adalimumab-Pfizer
  • Biological: Humira (adalimumab-EU)
    40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
    Other Name: adalimumab (European Union)
  • Biological: Humira (adalimumab-US)
    40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
    Other Name: adalimumab (United States)
  • Experimental: A
    PF-06410293
    Intervention: Biological: PF-06410293
  • Active Comparator: B
    Adalimumab-EU
    Intervention: Biological: Humira (adalimumab-EU)
  • Active Comparator: C
    Adalimumab-US
    Intervention: Biological: Humira (adalimumab-US)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
February 2014
February 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female (non-childbearing potential). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.

Exclusion Criteria:

  • Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   United States
 
 
NCT01870986
B5381001
REFLECTIONS B538-01
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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