Clinical Characterization of a Human Rhinovirus Type 16 Challenge Pool Following Intranasal Administration to Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Clinical symptoms to HRV-16
Study Overview
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 used in viral challenge studies with new compounds that are intended to treat respiratory diseases.
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 symptoms and other indicators. There will be 3 phases: a screening phase, an HRV-16 infection phase, and a follow-up phase. The dose of virus being tested in this study has been previously used in other challenge studies. The total length of participation in the study will be about 4 weeks. Participant safety will be monitored.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Clinical symptoms to HRV-16
Time Frame: 6 days
Clinical symptoms to HRV-16 will be assessed using the Cold Symptom Assessment form, which is a 5-point scale of the severity of cold symptoms.
Serological Response
Time Frame: Approximately 4 weeks
Blood samples will be evaluated for serum-neutralizing antibody titer levels to HRV-16.
Secondary Outcomes
- The number of adverse events(Approximately 4 weeks)