Clinical trial NCT05981976: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Abatacept
Orencia
Pharmacokinetics
Bioavailability
BMS-188667
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to Day 71
measure: 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
measure: Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))
timeFrame: Up to Day 71
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to Month 12
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Month 12
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Month 12
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 71
measure: Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))
timeFrame: Up to Day 71
measure: Serum concentration at 168 hours after dosing (C168)
timeFrame: Up to Day 71
measure: Time of maximum observed serum concentration (Tmax)
timeFrame: Up to Day 71
measure: Number of laboratory-reported positive responses of anti-abatacept antibodies
timeFrame: Up to Month 12
measure: Number of laboratory-reported positive responses of anti-CTLA4-T antibodies
timeFrame: Up to Day 71
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Local Institution
state: California
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: