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Completed

NCT Number: NCT02237729

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

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

De La Pedraja Radiology Associates, Coral Gables, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06410293

Biological

PF-06410293 will be administered as a single 40 mg, subcutaneous dose

Other names: Adalimumab-Pfizer

Adalimumab-US

Biological

Adalimumab-US will be administered as a single 40 mg, subcutaneous dose

Adalimumab-EU

Biological

Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose

Primary outcomes

  1. maximal serum concentration (Cmax)

    Time frame: Day 1 - Day 50

    maximal serum concentration (Cmax)

  2. area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk)

    Time frame: 0-336 hours

    area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)]

    Time frame: Day 1 - Day 50

    AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T)

  4. AUC extrapolated to infinity (AUC0inf)

    Time frame: Day 1 - Day 50

    AUC extrapolated to infinity (AUC0inf)

Secondary outcomes

  1. Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters

    Time frame: Day 1- Day 71

    Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters

  2. Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)

    Time frame: Day 1- Day 71

    Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)

  3. maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US

    Time frame: Day 1 - Day 50

    maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US

  4. area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US

    Time frame: 0-336 hours

    area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) for adalimumab EU as compared to adalimumab US

  5. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US

    Time frame: Day 1 - Day 50

    AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) for adalimumab EU as compared to adalimumab US

  6. AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US

    Time frame: Day 1 - Day 50

    AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US

  7. time to reach the maximum concentration (Tmax)

    Time frame: Day 1 - Day 50

    time to reach the maximum concentration (Tmax)

  8. Apparent clearance (CL/F)

    Time frame: Day 1 - Day 50

    Apparent clearance (CL/F)

  9. Apparent volume of distribution (Vz/F)

    Time frame: Day 1 - Day 50

    Apparent volume of distribution (Vz/F)

  10. Terminal half-life (T1/2)

    Time frame: Day 1 - Day 50

    Terminal half-life (T1/2)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: B538-07

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 11, 2014
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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