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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2019-04-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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