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A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants

Trial Profile

A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 04 Jan 2019

At a glance

  • Drugs Belatacept (Primary)
  • Indications Renal transplant rejection
  • Focus Pharmacokinetics
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 26 Dec 2018 Planned End Date changed from 15 Sep 2018 to 15 Jan 2019.
    • 24 May 2018 Planned End Date changed from 15 May 2018 to 15 Sep 2018.
    • 24 May 2018 Planned primary completion date changed from 15 May 2018 to 15 Sep 2018.
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