A Study of Human Rhinovirus Type 16 (HRV-16) Following Administration in the Nose of Healthy Adult Volunteers
Completed · Phase 1
Conditions studied: Healthy
In brief
The purpose of this study is to evaluate the safety and clinical characteristics of a quantity of human rhinovirus Type 16 (HRV-16) in healthy volunteers. This source of HRV-16 will be subsequently used in viral challenge studies with new compounds that are intended to treat respiratory diseases.
Key facts
- Study ID
- NCT01466738
- Run by
- Centocor Ortho Biotech Services, L.L.C.
- People needed
- 52
- Starts
- 2011-09-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2012-02-22
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Demonstrate an understanding of the study and sign an informed consent form prior to any study-related procedures
- Healthy with no clinically significant abnormalities as determined by medical history
- Women must be neither pregnant nor lactating (producing breast milk) and have a negative urine pregnancy test at Screening Visit 1
- Women of child-bearing potential and all men must agree to use adequate birth control measures (as determined by the investigator) and must agree to continue to use such measures and not plan a pregnancy until after the Day 6 visit
- Men must agree not to donate sperm during the study through the Day 6 visit
You may not qualify if…
- Have a documented serum-neutralizing antibody titer of > 2-fold dilution to HRV-16 in the blood sample within approximately 40 days of Screening Visit 2
- Live with a family member who cares for the elderly, infants, or small children (eg, nursing home or day care provider), or live with someone who has a chronic lung disease, premature infant, or immunocompromised individual
- Require a prescription or over-the-counter medication on a regular basis (3 or more times per week), except contraceptive preparations, hormone replacement therapy, or topical acne medication
- Have a history of chronic disease that the Investigator believes are clinically significant
- Have a history of chronic headaches (eg frequent migraines, cluster headaches) with 3 or more headaches per week
Where it is running
- Study site — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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