Poly Nasal Mist Study
Study name
A Phase I Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Tolerability of Topical Nasal Poly-ICLC
Study number
08-I-0093
Goal of Study
Doctors at the National Institutes of Health are conducting a new research study (08-I-0093) to test the safety of Poly-ICLC, a medication that is being studied for its ability to prevent infections from influenza and other viruses. This medication is squirted into the nose. Volunteers 18-70 years old who do not have any chronic medical problems, prior nasal surgery, allergies that require daily medication or lung conditions like asthma may be eligible. The NIH is recruiting patients residing in the Washington DC, Maryland, and Virginia metropolitan area.
Study Regimen
The study will recruit 50 participants. The study lasts 28 days, and consists of 3-5 visits and one telephone call. All participants will receive either one or two doses of the study medication Poly-ICLC, which is squirted into the nose. Cohorts 1-3 will receive either 0.25, 0.5 or 1 mg; cohorts 4-5 will receive either 1 mg or 2 mg of the study medication. Participants will have blood work done, as well as a nasal wash, which is a procedure where salt water is placed in the nose and removed by suction. Volunteers will be compensated.
Eligibility Criteria
- You are age 18-70 years old
- You have adequate veins for blood draws
- You are willing to receive the study medication
- You have normal blood counts and no chronic medical conditions
- You do not have any problems that require daily nasal medications
- You have not had previous nasal or sinus surgery
- You do not have allergies that require daily medication
- You do not have any chronic lung conditions like asthma
For questions about participating in any of these clinical studies, contact:
Patient Recruitment and Public Liaison Office
Toll Free: 1-800-411-1222
TTY: 1-866-411-1010
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Office hours: 8 am to 8 pm, Eastern Time |
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