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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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

Key facts

Study ID

NCT02237729

Run by

Pfizer

People needed

362

Starts

2014-09-01

Expected to finish

2015-03-01

Last updated by the study team

2015-04-13

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• SeaView Research, Inc. (Screening Office) — Miami, Florida, United States
• Vince & Associates Clinical Research, Inc. — Overland Park, Kansas, United States
• Vince & Associates Clinical Research, Inc. — Overland Park, Kansas, United States
• Prism Research, LLC — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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