Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects

Key facts

Study ID

NCT01439204

Run by

Bristol-Myers Squibb

People needed

223

Starts

2011-10-01

Expected to finish

2012-02-01

Last updated by the study team

2014-03-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
• Body weight will be between 60 and 100 kg, inclusive

You may not qualify if…

• Any significant acute or chronic medical illness
• Any major surgery within 4 weeks of study drug administration
• Smoking more than 10 cigarettes per day
• Recent (within 6 months of study drug administration) drug or alcohol abuse.
• Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1, Human Immunodeficiency Virus-2 antibody
• History of any significant drug allergy or asthma
• Women who are pregnant or breastfeeding and/or unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period

Where it is running

• Icon Clinical Pharmacology Unit, Llc — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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