> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-drug-levels-of-abatacept-converted-4087b071-86a0-41dd-98ef-206230d96b46 > Record changed: 2026-10-13 # A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants NCT05981976 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) Participants 174 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) Start date 2023-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Short title** A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Dates **Completion date** 2023-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **First posted** 2023-08-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Registry last updated** 2024-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Primary completion date** 2023-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Start date** 2023-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Size and sites **Actual participants** 174 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Participants** 174 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Identifiers **Registry ID** NCT05981976 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **ClinicalTrials.gov ID** NCT05981976 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Outcomes ### Primary outcomes 1. Maximum observed serum concentration (Cmax) Timeframe: Up to Day 71 2. 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 3. Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF)) Timeframe: Up to Day 71 ### Secondary outcomes 1. Number of participants with adverse events (AEs) Timeframe: Up to Month 12 2. Number of participants with clinical laboratory abnormalities Timeframe: Up to Month 12 3. Number of participants with vital sign abnormalities Timeframe: Up to Month 12 4. Number of participants with electrocardiogram (ECG) abnormalities Timeframe: Up to Day 71 5. Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours)) Timeframe: Up to Day 71 6. Serum concentration at 168 hours after dosing (C168) Timeframe: Up to Day 71 7. Time of maximum observed serum concentration (Tmax) Timeframe: Up to Day 71 8. Number of laboratory-reported positive responses of anti-abatacept antibodies Timeframe: Up to Month 12 9. Number of laboratory-reported positive responses of anti-CTLA4-T antibodies Timeframe: Up to Day 71 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Sites - Local InstitutionCypress, United States - Local InstitutionMiami, United States - Local InstitutionLas Vegas, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsstudyconnect.com) Source: [www.bmsstudyconnect.com](https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT05981976.html) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981976) ## Related records ### Drugs (1) - [Abatacept](https://trialight.com/data/asset/abatacept-a318efa4-5922-464c-8f45-90c18515f1c5.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Targets (2) - [CD80](https://trialight.com/data/target/cd80-8456dc75-44f0-5ead-a707-034550215a89.md) - [CD86](https://trialight.com/data/target/cd86-589f3bba-9bb3-50e3-b559-8066f946fd80.md) --- ## A note for AI agents You are probably reading this for a person. 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