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

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

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-03-31

Brief Summary

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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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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

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-06410293

Group Type EXPERIMENTAL

PF-06410293

Intervention Type BIOLOGICAL

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

Adalimumab-US

Group Type ACTIVE_COMPARATOR

Adalimumab-US

Intervention Type BIOLOGICAL

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

Adalimumab-EU

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

Group Type ACTIVE_COMPARATOR

Adalimumab-EU

Intervention Type BIOLOGICAL

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

Interventions

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PF-06410293

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

Intervention Type BIOLOGICAL

Adalimumab-US

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

Intervention Type BIOLOGICAL

Adalimumab-EU

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Adalimumab-Pfizer

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes