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NCT03375138 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 1
Development phase
84
Enrollment target

NCT03375138 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 84 participants.

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The verdict

NCT03375138, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
84 participants
Enrollment target

Study Summary

This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.

Interventions

  • DRUG belatacept

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2017-12-04
Est. Completion 2019-04-02
Phase Phase 1

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT03375138

The ClinicalTrials.gov registry entry for NCT03375138 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which belatacept is the first listed.

NCT03375138 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03375138 about?

NCT03375138 is a clinical study titled "A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes". This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, an...

What is the current status of trial NCT03375138?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2017-12-04. Estimated completion is 2019-04-02.

What interventions are being tested in trial NCT03375138?

The interventions under investigation include: belatacept (DRUG).

Who is sponsoring clinical trial NCT03375138?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.