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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 is a Phase 1 study that has completed, run by Vedanta Biosciences. The registered enrollment target is 39 participants.

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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.

Interventions

  • DRUG Oral Vancomycin
  • DRUG VE303

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2017-11-28
Est. Completion 2019-03-11
Phase Phase 1

Sponsor

Vedanta Biosciences

5 total trials

What the Registry Record Tells You About NCT04236778

The ClinicalTrials.gov registry entry for NCT04236778 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vedanta Biosciences, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Oral Vancomycin is the first listed.

NCT04236778 reports 0 study locations.

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.

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.