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NCT01747148 · ClinicalTrials.gov registry record · Phase 1

Testing the AVI-7100 Flu Drug in Healthy Volunteers

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT01747148 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 66 participants.

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The verdict

NCT01747148, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target

Study Summary

Background: \- Influenza (flu) is a virus that causes people to get sick. Most of the time, the flu causes only a mild illness, but some people can become seriously ill or even die from it. Currently, some pills and inhaled powders can be used to treat the flu, but they only make flu symptoms end about a day sooner. More treatment choices for the flu are needed, especially for those who become seriously ill. Researchers want to test a new drug, AVI-7100, that might keep a person who takes it from having a more serious case of the flu. Objectives: \- To see how healthy adult volunteers tolerate the AVI-7100 anti-influenza drug. Eligibility: \- Healthy volunteers of normal weight between 18 and 60 years of age. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. A heart function test will also be performed. * Participants will have either AVI-7100 or a placebo infusion. They will not know which infusion they have. . Participants will stay at the clinical center for a total of 8 hours after the infusion. Blood samples will be collected 1, 2, 4, and 8 hours after the end of the infusion * Participants will return on Days 1, 2, 4, 10, and 28 after receiving the drug. Blood and urine samples will be collected. A heart function test will also be performed. * There will be a second part of the study that is separate from the first one. Additional people will receive either AVI-7100 or placebo to test their reactions to a specific dose.

Interventions

  • DRUG AVI-7100 versus placebo

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2012-12-08
Est. Completion 2016-06-29
Phase Phase 1

What the Registry Record Tells You About NCT01747148

The ClinicalTrials.gov registry entry for NCT01747148 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which AVI-7100 versus placebo is the first listed.

NCT01747148 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01747148 about?

NCT01747148 is a clinical study titled "Testing the AVI-7100 Flu Drug in Healthy Volunteers". Background: \- Influenza (flu) is a virus that causes people to get sick. Most of the time, the flu causes only a mild illness, but some people can become seriously ill or even die from it. Currently, some pills and inhaled powders can be used to treat the flu, but they only make flu symptoms end a...

What is the current status of trial NCT01747148?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2012-12-08. Estimated completion is 2016-06-29.

What interventions are being tested in trial NCT01747148?

The interventions under investigation include: AVI-7100 versus placebo (DRUG).

Who is sponsoring clinical trial NCT01747148?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.