Status:
COMPLETED
A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 cur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT05981976
Start Date
August 18 2023
End Date
December 14 2023
Last Update
July 29 2024
Active Locations (3)
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1
Local Institution
Cypress, California, United States, 90630
2
Local Institution
Miami, Florida, United States, 33147
3
Local Institution
Las Vegas, Nevada, United States, 89113