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A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
De La Pedraja Radiology Associates
Coral Gables, Florida, 33134 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and female subjects between the ages of 18 and 45 years, inclusive.
Healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, complete physical examination including blood pressure and heart rate
measurement, 12 lead ECG and clinical laboratory tests.

- Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight >60 kg (132 lbs).

- Chest X ray with no evidence of current, active TB or previous (inactive) TB, general
infections, heart failure, malignancy, or other clinically significant abnormalities
taken at Screening or within 24 weeks prior to Day 1 and read by a qualified
radiologist.

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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
autoimmune, or allergic disease (including drug allergies, but excluding untreated,
asymptomatic, seasonal allergies at the time of dosing).

- Previous history of cancer, except for adequately treated basal cell or squamous cell
carcinoma of the skin.

NCT02237729
Pfizer
Completed
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))

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A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy Subjects
  • Biological: PF-06410293
    PF-06410293 will be administered as a single 40 mg, subcutaneous dose
    Other Name: Adalimumab-Pfizer
  • Biological: Adalimumab-US
    Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
  • Biological: Adalimumab-EU
    Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
  • Experimental: PF-06410293
    Intervention: Biological: PF-06410293
  • Active Comparator: Adalimumab-US
    Intervention: Biological: Adalimumab-US
  • Active Comparator: Adalimumab-EU
    Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
    Intervention: Biological: Adalimumab-EU
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
362
March 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight >60 kg (132 lbs).
  • Chest X ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02237729
B5381007
REFLECTIONS B538-07
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

ICMJE     Data element required by the

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

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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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