A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Biological: Abatacept
- Registration Number
- NCT05981976
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abatacept Treatment A Abatacept - Abatacept Treatment B Abatacept -
- Primary Outcome Measures
Name Time Method Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T)) Up to Day 71 Maximum observed serum concentration (Cmax) Up to Day 71 Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF)) Up to Day 71
- Secondary Outcome Measures
Name Time Method Time of maximum observed serum concentration (Tmax) Up to Day 71 Number of laboratory-reported positive responses of anti-abatacept antibodies Up to Month 12 Serum concentration at 168 hours after dosing (C168) Up to Day 71 Number of participants with adverse events (AEs) Up to Month 12 Number of participants with clinical laboratory abnormalities Up to Month 12 Number of participants with vital sign abnormalities Up to Month 12 Number of participants with electrocardiogram (ECG) abnormalities Up to Day 71 Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours)) Up to Day 71 Number of laboratory-reported positive responses of anti-CTLA4-T antibodies Up to Day 71
Trial Locations
- Locations (1)
Local Institution
🇺🇸Las Vegas, Nevada, United States