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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Biological: Abatacept

Study type

Interventional

Funder types

Industry

Identifiers

NCT05981976

IM101-920

Details and patient eligibility

About

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.

Enrollment

174 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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