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NCT04236778 · ClinicalTrials.gov registry record · Phase 1
First-in-human Study of VE303 in Healthy Adult Volunteers
A Phase 1 study, sponsored by Vedanta Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT04236778: Completed Phase 1 study, sponsored by Vedanta Biosciences.
NCT04236778 is a Phase 1 study that has completed, run by Vedanta Biosciences. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04236778, a Phase 1 study, has completed, sponsored by Vedanta Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administration of antibiotics followed by a course of VE303.
Primary Outcome
Measured in terms of incidence of AEs according to CTCAE V4.0
Interventions
- DRUG Oral Vancomycin
- DRUG VE303
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2019-03-11 |
| Phase | Phase 1 |
What the finished NCT04236778 record still lists
NCT04236778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Oral Vancomycin is the first listed.
NCT04236778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04236778 about?
NCT04236778 is a clinical study titled "First-in-human Study of VE303 in Healthy Adult Volunteers". This study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administration of antibiotics f...
What is the current status of trial NCT04236778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2017-11-28. Estimated completion is 2019-03-11.
What interventions are being tested in trial NCT04236778?
The interventions under investigation include: Oral Vancomycin (DRUG), VE303 (DRUG).
Who is sponsoring clinical trial NCT04236778?
This trial is sponsored by Vedanta Biosciences, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04236778's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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