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NCT02371668 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Volunteer Human Challenge Model
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT02371668 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 104 participants.
The verdict
NCT02371668, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
Background: \- Researchers want to see if a new drug reduces flu disease in people treated with this drug versus a placebo. The drug has an antibody that may help the immune system fight the flu. Placebo is only sugar and water. All participants will get the flu virus. They may or may not develop flu symptoms. Objective: \- To see if the drug CR6261 reduces flu disease in people treated with this drug versus a placebo. Eligibility: \- Healthy nonsmokers ages 18 45. Design: * Participants will be screened under a separate protocol. * Participants must use contraception or abstinence for several weeks before and after the study. They must have no alcohol for 1 day before each visit. Any medicine must be approved by the study doctor until after follow-up. * Participants will stay in a hospital isolation unit for at least 10 days. * They will have: * Medical history * Physical exam * Blood and urine tests * Heart and lung test * Tests for drugs and alcohol * Throughout their stay, participants will: * Be closely watched by a medical team * Have nasal washes and swabs several times a day * Participants will have the flu virus sprayed in each nostril. * The next day, participants will get either study drug or placebo through a soft plastic tube placed in a vein by needle. It will take 2 hours. They will not know which they get. * Participants can go home after 10 days if they test negative for the flu 2 days in a row. * Participants will have daily questionnaires at home and 2 follow-up visits over 2 months.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL CR6261
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2015-02-25 |
| Est. Completion | 2018-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02371668
The ClinicalTrials.gov registry entry for NCT02371668 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 104 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.
NCT02371668 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02371668 about?
NCT02371668 is a clinical study titled "Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Volunteer Human Challenge Model". Background: \- Researchers want to see if a new drug reduces flu disease in people treated with this drug versus a placebo. The drug has an antibody that may help the immune system fight the flu. Placebo is only sugar and water. All participants will get the flu virus. They may or may not develop f...
What is the current status of trial NCT02371668?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2015-02-25. Estimated completion is 2018-11-30.
What interventions are being tested in trial NCT02371668?
The interventions under investigation include: Placebo (BIOLOGICAL), CR6261 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02371668?
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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