Healthy Participants Clinical Trial
Official title:
A Randomized, Open-Label, Parallel-Group, Single-dose, Relative Bioavailability Study of the Pharmacokinetics of Subcutaneous Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process J Relative to the Current Abatacept Drug Process F in Healthy Participants
The purpose of this study is to compare the relative absorption of abatacept in healthy participants following subcutaneous (SC) administration in which the drug substance is manufactured with the current or new process.
| Status | Not yet recruiting |
| Enrollment | 174 |
| Est. completion date | December 25, 2023 |
| Est. primary completion date | December 25, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Healthy participants, defined as having no clinically significant deviation from normal in medical history; physical examinations that would compromise the ability to participate, complete, and/or interpret the results of the study; 12-lead ECG; vital signs; and clinical laboratory results - Body weight between 60 and 100 kilograms (kg) inclusive, based on weight at screening - Participant must have a suitable injection site without tattoos, scarring, or other conditions in the upper, outer arm that could interfere with SC administration Exclusion Criteria: - Present malignancy or previous malignancy within the last 5 years prior to screening - At risk for tuberculosis - Any chronic bacterial infection within the previous 12 weeks of dosing Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution | Cypress | California |
| United States | Local Institution | Las Vegas | Nevada |
| United States | Local Institution | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed serum concentration (Cmax) | Up to Day 71 | ||
| Primary | Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T)) | Up to Day 71 | ||
| Primary | Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF)) | Up to Day 71 | ||
| Secondary | Number of participants with adverse events (AEs) | Up to Month 12 | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to Month 12 | ||
| Secondary | Number of participants with vital sign abnormalities | Up to Month 12 | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 71 | ||
| Secondary | Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours)) | Up to Day 71 | ||
| Secondary | Serum concentration at 168 hours after dosing (C168) | Up to Day 71 | ||
| Secondary | Time of maximum observed serum concentration (Tmax) | Up to Day 71 | ||
| Secondary | Number of laboratory-reported positive responses of anti-abatacept antibodies | Up to Month 12 | ||
| Secondary | Number of laboratory-reported positive responses of anti-CTLA4-T antibodies | Up to Day 71 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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