Status:
COMPLETED
A Study of Human Rhinovirus Type 16 (HRV-16) Following Administration in the Nose of Healthy Adult Volunteers
Lead Sponsor:
Centocor Ortho Biotech Services, L.L.C.
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 us...
Detailed Description
This is an open-label study in which all participants know the investigational substance being tested. Participants will be inoculated in the nose with HRV-16 and evaluated for the occurrence of cold ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01466738
Start Date
September 1 2011
End Date
November 1 2011
Last Update
February 22 2012
Active Locations (1)
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1
Charlottesville, Virginia, United States