Pharmacokinetic Study to Compare the Blood Levels of Low vs High Metal Manufacture of Abatacept

• Status: Withdrawn
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept

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