deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT03375138

A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes

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

Sponsor: Bristol-Myers Squibb

Interventions belatacept
Updated 8 times since 2017 Last updated: Jul 23, 2019 Started: Dec 4, 2017 Primary completion: May 8, 2018 Completion: Apr 2, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Healthy Volunteers and is currently completed. Bristol-Myers Squibb leads this study, which shows 8 recorded versions since 2017 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotRecruiting~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshotActive Not Recruiting~Jan 2019 – ~May 2019 · 4 months · monthly snapshotActive Not Recruiting~May 2019 – ~Aug 2019 · 3 months · monthly snapshotCompleted~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Aug 2019 — Jan 2021 [monthly]

    Completed PHASE1

  5. May 2019 — Aug 2019 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

Show 3 earlier versions
  1. Jan 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE1

  2. Jun 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  3. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bristol-Myers Squibb
Data source: Bristol-Myers Squibb

For direct contact, visit the study record on ClinicalTrials.gov .