A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants
- 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.
- Short title
- A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-12-14
- First posted
- 2023-08-08
- Registry last updated
- 2024-07-29
- Primary completion date
- 2023-12-14
- Start date
- 2023-08-18
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Bristol-Myers Squibb
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05981976
- ClinicalTrials.gov ID
- NCT05981976
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Maximum observed serum concentration (Cmax)
Timeframe: Up to Day 71
Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))
Timeframe: Up to Day 71
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))
Timeframe: Up to Day 71
Number of participants with adverse events (AEs)
Timeframe: Up to Month 12
Number of participants with clinical laboratory abnormalities
Timeframe: Up to Month 12
Number of participants with vital sign abnormalities
Timeframe: Up to Month 12
Number of participants with electrocardiogram (ECG) abnormalities
Timeframe: Up to Day 71
Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))
Timeframe: Up to Day 71
Serum concentration at 168 hours after dosing (C168)
Timeframe: Up to Day 71
Time of maximum observed serum concentration (Tmax)
Timeframe: Up to Day 71
Number of laboratory-reported positive responses of anti-abatacept antibodies
Timeframe: Up to Month 12
Number of laboratory-reported positive responses of anti-CTLA4-T antibodies
Timeframe: Up to Day 71
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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
- 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
- Local InstitutionCypress, United States
- Local InstitutionMiami, United States
- Local InstitutionLas Vegas, United States
- Related resource (www.bms.com)
- Related resource (www.bmsstudyconnect.com)