Expired Study
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Austin, Texas 78744


Purpose:

The purpose of this study is to determine whether the blood levels of abatacept drug product manufactured using High Metals and using Low Metals are comparable in healthy subjects.


Study summary:

Compare the pharmacokinetic (PK) of High Metals abatacept relative to Low Metals abatacept following a single intravenous infusion of 750 mg in healthy subjects.


Criteria:

Inclusion Criteria: - Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations - Body weight will be between 60 and 100 kg, inclusive Exclusion Criteria: - 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 HIV-1, -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


NCT ID:

NCT01221636


Primary Contact:

Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb


Backup Contact:

N/A


Location Contact:

Austin, Texas 78744
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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