Protocol Number: 08-I-0093
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 card. -Day 28: Subjects are contacted by phone to review their diary card.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
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