CompletedNCT05981976Updated Jul 29, 2024

A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants

A Phase 1 interventional study of Abatacept in Healthy Participants, sponsored by Bristol-Myers Squibb. Completed at 3 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Dec 2023, 2 years 9 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 174
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Healthy Participants

Keywords

Abatacept
Orencia
Pharmacokinetics
Bioavailability
BMS-188667

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts 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

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 174 participants (actual)

Study arms

Experimental
Abatacept Treatment A
Biological: Abatacept
Experimental
Abatacept Treatment B
Biological: Abatacept

Interventions

BiologicalAbatacept
Specified dose on specified days
Also known as: Orencia®, BMS-188667

What researchers measure

Primary outcomes

Maximum observed serum concentration (Cmax)
Time frame: Up to Day 71
Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))
Time frame: Up to Day 71
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))
Time frame: Up to Day 71

Secondary outcomes

Number of participants with adverse events (AEs)
Time frame: Up to Month 12
Number of participants with clinical laboratory abnormalities
Time frame: Up to Month 12
Number of participants with vital sign abnormalities
Time frame: Up to Month 12
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 71
Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))
Time frame: Up to Day 71
Serum concentration at 168 hours after dosing (C168)
Time frame: Up to Day 71
Time of maximum observed serum concentration (Tmax)
Time frame: Up to Day 71
Number of laboratory-reported positive responses of anti-abatacept antibodies
Time frame: Up to Month 12
Number of laboratory-reported positive responses of anti-CTLA4-T antibodies
Time frame: Up to Day 71

Study locations

3 sites

Local Institution
Cypress, California 90630, United States
Local Institution
Miami, Florida 33147, United States
Local Institution
Las Vegas, Nevada 89113, United States

References and documents

Individual participant data

Plan to share: No — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05981976
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Aug 8, 2023
Start date: Aug 18, 2023
Primary completion: Dec 14, 2023
Completion: Dec 14, 2023
Last update: Jul 29, 2024

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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