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

NCT01466738 | Completed Phase 1

• 2 other identifiers: CR018733NOCOMPOUNDASH1001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy volunteer; Rhinovirus; Cold virus; HRV-16

Outcome Measures

Primary Outcomes (2)

• Clinical symptoms to HRV-16

  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.

  6 days

• Serological Response

  Blood samples will be evaluated for serum-neutralizing antibody titer levels to HRV-16.

  Approximately 4 weeks

Secondary Outcomes (1)

• The number of adverse events

  Approximately 4 weeks

Study Arms (2)

HRV-16 (100 TCID50)

EXPERIMENTAL

Biological: HRV-16 (100 TCID50)

HRV-16 (1000 TCID50)

EXPERIMENTAL

Biological: HRV-16 (1000 TCID50)

Interventions

HRV-16 (100 TCID50) BIOLOGICAL

Each volunteer will receive a single administration of 100 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.

HRV-16 (100 TCID50)

HRV-16 (1000 TCID50) BIOLOGICAL

Each volunteer will receive a single administration of 1000 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.

HRV-16 (1000 TCID50)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Centocor Ortho Biotech Services, L.L.C.: lead

Study Sites (1)

Unknown Facility

Charlottesville, Virginia, United States

Location

Study Officials

• Centocor Ortho Biotech Services, L.L.C. Clinical Trial

  Centocor Ortho Biotech Services, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 8, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (1)