Rheumatoid Arthritis
Conditions
Brief 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.
Detailed description
Compare the pharmacokinetic (PK) of High Metals abatacept relative to Low Metals abatacept following a single intravenous infusion of 750 mg in healthy subjects.
Interventions
DRUGAbatacept
Solution for injection, Intravenous, 750 mg, 1 day
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Single-dose pharmacokinetic parameters: Cmax (Maximum observed serum concentration) | Over 71 days after single dose administered |
| Single-dose pharmacokinetic parameters: AUC 0-71 days (Area under the serum concentration-time curve from time zero to 71 days) | Over 71 days after single dose administered |
| Single-dose pharmacokinetic parameters: AUC (INF) (Area under the serum concentration-time curve from time zero extrapolated to infinity) | Over 71 days after single dose administered |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity determination will be based on titers of anti abatacept and anti-CTLA-4-T antibodies in serum over time | Days 29, 57, and 71 after single dose administered |
| Safety assessments: adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests. The incidence of observed adverse events will be tabulated and reviewed for potential significance and clinical importance | Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71 after single dose administration |
Countries
United States
Outcome results
None listed