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

Pfizer362 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

362

Conditions

Healthy Subjects

Interventions

PF-06410293BIOLOGICAL

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

Adalimumab-USBIOLOGICAL

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

Adalimumab-EUBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

De La Pedraja Radiology Associates

Coral Gables, Florida, United States

SeaView Jacksonville

Jacksonville, Florida, United States

SeaView Research, Inc.

Miami, Florida, United States

SeaView Reseach Screening Office

Miami, Florida, United States

Outcomes

Primary Outcomes

maximal serum concentration (Cmax)

Time frame: Day 1 - Day 50

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

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

Time frame: 0-336 hours

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

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

Time frame: Day 1 - Day 50

AUC extrapolated to infinity (AUC0inf)

Time frame: Day 1 - Day 50

Secondary Outcomes

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

Time frame: Day 1- Day 71

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

Time frame: Day 1- Day 71

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

Time frame: Day 1 - Day 50

Data from ClinicalTrials.gov

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