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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05981976
Collaborator
(none)
174
Enrollment
3
Locations
2
Arms
4.3
Anticipated Duration (Months)
58
Patients Per Site
13.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Abatacept
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
174 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Dec 25, 2023
Anticipated Study Completion Date :
Dec 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Abatacept Treatment A

Biological: Abatacept
Specified dose on specified days
Other Names:
  • Orencia®
  • BMS-188667

    		•
    Experimental: Abatacept Treatment B

    Biological: Abatacept
    Specified dose on specified days
    Other Names:
  • Orencia®
  • BMS-188667

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed serum concentration (Cmax) [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)) [Up to Day 71]

    3. Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF)) [Up to Day 71]

    Secondary Outcome Measures

    1. Number of participants with adverse events (AEs) [Up to Month 12]

    2. Number of participants with clinical laboratory abnormalities [Up to Month 12]

    3. Number of participants with vital sign abnormalities [Up to Month 12]

    4. Number of participants with electrocardiogram (ECG) abnormalities [Up to Day 71]

    5. Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours)) [Up to Day 71]

    6. Serum concentration at 168 hours after dosing (C168) [Up to Day 71]

    7. Time of maximum observed serum concentration (Tmax) [Up to Day 71]

    8. Number of laboratory-reported positive responses of anti-abatacept antibodies [Up to Month 12]

    9. Number of laboratory-reported positive responses of anti-CTLA4-T antibodies [Up to Day 71]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Cypress California United States 90630
    2 Local Institution Miami Florida United States 33147
    3 Local Institution Las Vegas Nevada United States 89113

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05981976
    Other Study ID Numbers:
    • IM101-920
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Abatacept
    Orencia
    Pharmacokinetics
    Bioavailability
    BMS-188667
    Additional relevant MeSH terms:
    Abatacept

    Study Results

    No Results Posted as of Aug 8, 2023