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NCT00646152 · ClinicalTrials.gov registry record · Phase 1
Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT00646152 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 57 participants.
The verdict
NCT00646152, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
This study will examine the safety of an experimental medication called Poly-ICLC, developed for preventing or reducing the severity of infections from influenza and other viruses acquired through the nose, mouth and lungs. The study is divided into two parts, in which Poly-ICLC is tested at different dose levels. Healthy people between 18 and 70 years of age who have no chronic medical problems may be eligible for this study. Participants undergo the following procedures: Part I * Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests. * Day 1: Nasal wash and Poly-ICLC administration. A small amount of salt water is placed into the front of the nose and then suctioned out. Poly-ICLC is then squirted into each nostril, one after the other, at a dose of 0.25, 0.5 or 1 mg. A small number of subjects are given a placebo (a solution with no active ingredient.) Subjects are observed in the clinic for 30 minutes after treatment. * Day 2: Subjects receive a second nasal wash and repeat blood tests. They keep a diary card for 1 week, recording any drug side effects. * Day 5: Subjects have repeat blood tests and a review of their diary card. The keep a diary card for another 3 weeks. * Day 12: Subjects are contacted by phone to review their diary card. * Day 28: Subjects are contacted by phone to review their diary card. Part II * Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests. * Day 1: Nasal wash and Poly-ICLC administration. Same as above for Part I participants. * Day 3: Subjects receive a second dose of medication and are observed again for 30 minutes. * Day 4: Subjects receive a second nasal wash and repeat blood tests. They keep a diary card for 1 week, recording any drug side effects. * Day 7: Subjects have repeat blood tests and a review of their diary card. The keep a diary card for another 3 weeks. * Day 14: Subjects are contacted by phone to review their diary ca
Interventions
- DRUG Poly-ICLC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2008-03-24 |
| Est. Completion | 2009-12-16 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00646152
The ClinicalTrials.gov registry entry for NCT00646152 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 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 Poly-ICLC is the first listed.
NCT00646152 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00646152 about?
NCT00646152 is a clinical study titled "Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study". This study will examine the safety of an experimental medication called Poly-ICLC, developed for preventing or reducing the severity of infections from influenza and other viruses acquired through the nose, mouth and lungs. The study is divided into two parts, in which Poly-ICLC is tested at differe...
What is the current status of trial NCT00646152?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2008-03-24. Estimated completion is 2009-12-16.
What interventions are being tested in trial NCT00646152?
The interventions under investigation include: Poly-ICLC (DRUG).
Who is sponsoring clinical trial NCT00646152?
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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