Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Process E PPQ belatacept | Experimental | 10 mg/kg, single dose by intravenous (IV) infusion. |
|
| Process C belatacept | Experimental | 10 mg/kg, single dose by intravenous (IV) infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| belatacept | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)). | Measured by plasma concentration. | Up to day 57 |
| Maximum observed serum concentration (Cmax). | Measured by plasma concentration. | Up to day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of non-serious Adverse Events (AEs). | Safety and tolerability as measured by incidence of non-serious AEs. | Up to 71 days. |
| Incidence of Serious Adverse Events (SAEs). | Safety and tolerability as measured by incidence of SAEs. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Austin Clinic | Austin | Texas | 78744 | United States | ||
| Covance, Inc. |
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Information | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 71 days. |
| Incidence of Adverse Events (AEs) leading to discontinuation. | Safety and tolerability as measured by incidence of AEs leading to discontinuation. | Up to 71 days. |
| Number of participants with vital sign abnormalities. | Up to 71 days. |
| Number of participants with physical examination abnormalities. | Up to 71 days. |
| Number of participants with clinical laboratory abnormalities. | Up to 71 days. |
| Number of participants with electrocardiogram (ECG) abnormalities. | Up to 71 days. |
| Dallas |
| Texas |
| 75247 |
| United States |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |