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OpenTrials
Completed

NCT Number: NCT05981976

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

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 information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Cypress, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 and study plan

Abatacept

Biological

Specified dose on specified days

Other names: Orencia®, BMS-188667

Primary outcomes

  1. Maximum observed serum concentration (Cmax)

    Time frame: 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))

    Time frame: Up to Day 71

  3. Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))

    Time frame: Up to Day 71

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to Month 12

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Month 12

  3. Number of participants with vital sign abnormalities

    Time frame: Up to Month 12

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 71

  5. 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

  6. Serum concentration at 168 hours after dosing (C168)

    Time frame: Up to Day 71

  7. Time of maximum observed serum concentration (Tmax)

    Time frame: Up to Day 71

  8. Number of laboratory-reported positive responses of anti-abatacept antibodies

    Time frame: Up to Month 12

  9. Number of laboratory-reported positive responses of anti-CTLA4-T antibodies

    Time frame: Up to Day 71

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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