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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PF-06410293 PFS (Prefilled Syringe)

PF-06410293 40 mg administered by Prefilled Syringe (PFS)

Group Type ACTIVE_COMPARATOR

PF-06410293 PFS

Intervention Type DEVICE

PF-06410293 40 mg administered subcutaneously by Prefilled syringe

PF-06410293 PFP (Prefilled Pen)

PF-06410293 40 mg administered by Prefilled pen

Group Type ACTIVE_COMPARATOR

PF-06410293 PFP

Intervention Type DEVICE

PF-06410293 40 mg administered subcutaneously by prefilled pen

Interventions

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PF-06410293 PFS

PF-06410293 40 mg administered subcutaneously by Prefilled syringe

Intervention Type DEVICE

PF-06410293 PFP

PF-06410293 40 mg administered subcutaneously by prefilled pen

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 pounds).
3. 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.
4. 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

1. 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).
2. Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
3. History of relevant orthostatic hypotension, fainting spells or blackouts.
4. Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes