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Completed

NCT Number: NCT02572245

A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects

This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy female subjects and/or male subjects, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG), and clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 pounds).
  • Chest X ray with no evidence of current, active TB or previous (inactive) TB, fungal or 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.
  • Female subjects of non childbearing potential must meet at least one of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post menopausal state; b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed ovarian failure.

All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.

Exclusion criteria

  • Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
  • History of relevant orthostatic hypotension, fainting spells or blackouts.
  • Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin

Treatment and study plan

PF-06410293 PFS

Device

PF-06410293 40 mg administered subcutaneously by Prefilled syringe

PF-06410293 PFP

Device

PF-06410293 40 mg administered subcutaneously by prefilled pen

Primary outcomes

  1. Maximum serum concentration (Cmax)

    Time frame: Day 1 - Day 15

  2. Area under the concentration curve (AUC 0-2wk)

    Time frame: Day 1-Day 15

Secondary outcomes

  1. Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose

    Time frame: Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection

    Mean injection site pain over a 24 hour period post dose rated by subject on a visual analog scale (VAS), compared for injection by PFS or PFP, and for the 2 injection locations using each device

  2. Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose

    Time frame: 1, 3, 8, 12 and 24 hours post injection

    Mean injection site tolerability using the Modified Draize Scale Numerical Grade over 24 hours post dose rated by the blinded Safety Assessor, compared for injection by PFS or PFP, and for the 2 injection locations using each device

  3. Time to reach the maximum serum concentration (Tmax)

    Time frame: Day 1 - Day 43

  4. AUC from time 0 to the last time point with quantifiable concentration (AUCT)

    Time frame: Day 1 - Day 43

  5. AUC extrapolated to infinity (AUC0 inf)

    Time frame: Day 1 - Day 43

  6. Volume of distribution (Vz/F),

    Time frame: Day 1 - Day 43

  7. Apparent clearance (CL/F)

    Time frame: Day 1 - Day 43

  8. Terminal half life (t1/2)

    Time frame: Day 1 - Day 43

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Comparability Study To Assess The Pharmacokinetics Of Pf-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects

Acronym: B538-05

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2015
Registry last updated
Jun 6, 2016

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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