A Study of Human Rhinovirus Type 16 (HRV-16) Following Administration in the Nose of Healthy Adult Volunteers

Centocor Ortho Biotech

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: HRV-16 (1000 TCID50)

Biological: HRV-16 (100 TCID50)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01466738

CR018733

NOCOMPOUNDASH1001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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