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Trial ID IM101-920  |   NCT05981976

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

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-55
    Age Range
  • 3
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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.

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Key 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Abatacept Treatment A

ASSIGNED INTERVENTION
  • Biological: Abatacept

Study Arms

Experimental: Abatacept Treatment B

ASSIGNED INTERVENTION
  • Biological: Abatacept
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