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NCT01651494 · ClinicalTrials.gov registry record · Phase 1
Influenza Antiviral DAS-181-F04 in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01651494 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 9 participants.
The verdict
NCT01651494, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study will be a double-blind, randomized, placebo-controlled study of a single dose (20mg) of Influenza Antiviral DAS181-F04 for 3 days. The group of nine subjects will be randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the inpatient clinic at a minimum of the night prior to first dose. The subjects will stay in the inpatient clinic for the duration of dosing and one day after dosing, they will be required to come back for follow-up visits on study days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days), and 90 (+/-10 days). The safety parameters will include abnormal laboratory values, adverse events and clinical observations.
Interventions
- OTHER Placebo
- DRUG DAS181
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-08-12 |
| Est. Completion | 2012-09-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01651494
The ClinicalTrials.gov registry entry for NCT01651494 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 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 2 interventions - of which Placebo is the first listed.
NCT01651494 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01651494 about?
NCT01651494 is a clinical study titled "Influenza Antiviral DAS-181-F04 in Healthy Adults". This study will be a double-blind, randomized, placebo-controlled study of a single dose (20mg) of Influenza Antiviral DAS181-F04 for 3 days. The group of nine subjects will be randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the inpatient clinic at a minimum of the...
What is the current status of trial NCT01651494?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-08-12. Estimated completion is 2012-09-18.
What interventions are being tested in trial NCT01651494?
The interventions under investigation include: Placebo (OTHER), DAS181 (DRUG).
Who is sponsoring clinical trial NCT01651494?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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