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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: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT03375138 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measured by plasma concentration.
Interventions
- DRUG belatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2019-04-02 |
| Phase | Phase 1 |
What the finished NCT03375138 record still lists
NCT03375138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 1 intervention - of which belatacept is the first listed.
NCT03375138 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03375138's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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