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NCT01173224 · ClinicalTrials.gov registry record · Phase 1
Influenza Antiviral DAS181-F03
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01173224 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 18 participants.
The verdict
NCT01173224, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Influenza (flu) is a common respiratory infection and often causes severe illness. Few drugs are currently approved to treat influenza. This research will test the safety of an experimental anti-influenza drug called DAS181 that is given through an inhaler. The purpose of this study is to evaluate the safety of this new medication and how the body reacts to it. Any side effects will be measured by symptoms, physical examination or laboratory studies. About 27 healthy men and women age 18-45, who meet screening requirements, will participate. Three separate groups will be enrolled, with approximately 9 subjects in each group. Cohort 1:20 mg DAS181 or placebo for 1 day (total dose of 20 mg). Cohort 2: 20 mg DAS181 or placebo for 10 consecutive days (total dose of 200 mg). Cohort 3: 30 mg DAS 181 or placebo for 1 day (total dose of 30 mg.) Procedures include blood samples, electrocardiograms (measures heart activity) and breathing tests.
Interventions
- DRUG Placebo
- DRUG DAS181
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01173224
The ClinicalTrials.gov registry entry for NCT01173224 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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.
NCT01173224 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01173224 about?
NCT01173224 is a clinical study titled "Influenza Antiviral DAS181-F03". Influenza (flu) is a common respiratory infection and often causes severe illness. Few drugs are currently approved to treat influenza. This research will test the safety of an experimental anti-influenza drug called DAS181 that is given through an inhaler. The purpose of this study is to evaluate t...
What is the current status of trial NCT01173224?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-11. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01173224?
The interventions under investigation include: Placebo (DRUG), DAS181 (DRUG).
Who is sponsoring clinical trial NCT01173224?
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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