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NCT02061358 · ClinicalTrials.gov registry record · Phase 1

Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

A Phase 1 study, sponsored by Emergent BioSolutions.

Completed
Registry status
Phase 1
Development phase
64
Enrollment target

NCT02061358 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 64 participants.

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The verdict

NCT02061358, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.

COMPLETED
Registry status
Phase 1
Development phase
64 participants
Enrollment target

Study Summary

The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.

Interventions

  • DRUG UV-4B 3 mg
  • DRUG UV-4B 10 mg
  • DRUG UV-4B 30 mg
  • DRUG UV-4B 90 mg
  • DRUG UV-4B 180 mg

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2014-07
Est. Completion 2015-09
Phase Phase 1

Sponsor

Emergent BioSolutions

34 total trials

What the Registry Record Tells You About NCT02061358

The ClinicalTrials.gov registry entry for NCT02061358 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emergent BioSolutions, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which UV-4B 3 mg is the first listed.

NCT02061358 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02061358 about?

NCT02061358 is a clinical study titled "Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects". The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.

What is the current status of trial NCT02061358?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2014-07. Estimated completion is 2015-09.

What interventions are being tested in trial NCT02061358?

The interventions under investigation include: UV-4B 3 mg (DRUG), UV-4B 10 mg (DRUG), UV-4B 30 mg (DRUG), UV-4B 90 mg (DRUG), UV-4B 180 mg (DRUG).

Who is sponsoring clinical trial NCT02061358?

This trial is sponsored by Emergent BioSolutions, which has 34 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.