Influenza Clinical Trial
Official title:
A Phase I Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Tolerability of Topical Nasal Poly-ICLC
Verified date | July 1, 2014 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 card.
- Day 28: Subjects are contacted by phone to review their diary card.
Status | Completed |
Enrollment | 57 |
Est. completion date | December 16, 2009 |
Est. primary completion date | December 16, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
- INCLUSION CRITERIA: Healthy volunteers age greater than or equal to 18 years and less than or equal to 70 years. For 2 months prior to study drug administration, and through the last day of follow-up (Day 28), subjects must agree to: - Not take any topical nasal medications (prescription or over the counter). - Not receive live attenuated influenza vaccine (Flumist) or any other live attenuated intranasal vaccine (licensed or research). - Not receive any other investigational medications or vaccines. Females of child-bearing potential must agree to use one of the following methods of contraception for 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration: - Be surgically sterile. - Use oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches. - Use an intra-uterine device (IUD). - Use (by ensuring her male partner(s) uses) barrier contraception (condom) with a spermicide. - Any other equivalent (as judged by the investigative team) methods of contraception. EXCLUSION CRITERIA: A medical history that includes any of the following: Any chronic medical problem that requires daily topical nasal medications. Prior nasal or sinus surgery (including trans-nasal approaches of other organs such as pituitary). Allergic rhinitis, chronic sinusitis, or any other nasal inflammatory disease that requires daily intranasal or oral medication. Any chronic pulmonary conditions including (but not limited to) asthma, chronic obstructive pulmonary disease, and chronic bronchitis. Subjects with known hypersensitivity to interferons. Any other medical history that in the opinion of the investigator significantly increases the risk associated with a Phase I drug (e.g. Patients with coronary heart disease, congestive heart failure, HIV, neuropsychiatric disorders, seizure disorder, autoimmune disease, hepatic decompensation, poorly controlled endocrine disorders (including poorly controlled diabetes, and actively hyper- or hypo-thyroid), hematological disorders (e.g. leukopenia, thrombocytopenia), ophthalmologic disorders (excluding errors or refractiveness) or other disorders for which symptoms of the condition could be similar to interferon-related toxicity or that might be exacerbated by interferon would be excluded. Patients with mild stable conditions, such as controlled hypertension, controlled diabetes, and osteoarthritis would be permitted to enroll.) Any history of habitual intranasal cocaine or other intranasal recreational drug use at any time, or experimental intranasal concaine or other intranasal recreational drug use within the last 10 years. (e.g. a 50 year old who tried cocaine once at age 20 is acceptable for enrollment). Women who are breast-feeding. Positive urine or serum pregnancy test. Participation in any research protocol that requires more than 100cc of blood to be given in any 6-week period of time. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Dushoff J, Plotkin JB, Viboud C, Earn DJ, Simonsen L. Mortality due to influenza in the United States--an annualized regression approach using multiple-cause mortality data. Am J Epidemiol. 2006 Jan 15;163(2):181-7. Epub 2005 Nov 30. — View Citation
Hui DS, Sung JJ. Severe acute respiratory syndrome. Chest. 2003 Jul;124(1):12-5. Review. — View Citation
Shortridge KF. Severe acute respiratory syndrome and influenza: virus incursions from southern China. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1416-20. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of AE greater than or equal to grade 2 by subjects who receive drug | |||
Secondary | Intranasal cytokines, nasal NO production, inflammatory cells in nasal wash |
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