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

Status:	Completed
Conditions:	Healthy Studies
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - 45
Updated:	3/16/2015
Start Date:	September 2014
End Date:	March 2015
Contact:	Pfizer CT.gov Call Center
Phone:	1-800-718-1021

Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects

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

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.

We found this trial at

sites

SeaView Research Inc.

Miami, Florida 33126

from

Miami, FL