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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: Adalimumab-EU; Biological: Adalimumab-US; Biological: PF-06410293

Study type: Interventional

Funder types: Industry

Identifiers

NCT02237729

B5381007

REFLECTIONS B538-07

Details and patient eligibility

About

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

Enrollment: 362 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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362 participants in 3 patient groups

PF-06410293

Experimental group

Treatment:

Biological: PF-06410293

Adalimumab-US

Active Comparator group

Treatment:

Biological: Adalimumab-US

Adalimumab-EU

Active Comparator group

Description:

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

Treatment:

Biological: Adalimumab-EU