Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
Phase 2
Completed
- Conditions
- Respiratory Syncytial Virus Infections
- Registration Number
- NCT00496821
- Lead Sponsor
- Alnylam Pharmaceuticals
- Brief Summary
The purpose of this study is to determine the safety, tolerability and efficacy of intranasal ALN-RSV01 versus placebo, administered once daily for 5 days to a healthy male volunteers experimentally inoculated with RSV
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 88
Inclusion Criteria
- Availability for the required study period (including the inpatient phase, ability to comply with study requirements and attend follow-up study visits
- Able to provide written consent for participation after reading the Consent Form and after having adequate opportunity to discuss the study with an investigator or qualified deputy.
- Good general health status as determined by a screening evaluation no greater than 120 days but not less than 14 days prior to enrollment and admission to the research unit
- Low titers of RSV neutralizing antibody measured during screening.
Exclusion Criteria
-
Significant acute or chronic, uncontrolled medical illness
-
Presence of household member or close contact to someone who:
- Is less than three(3) years of age
- Has a known immunodeficiency
- Is receiving immunosuppressant drugs
- Is undergoing or soon to undergo cancer chemotherapy within 28 days of enrollment
- Has diagnosed emphysema, chronic obstructive pulmonary disease(COPD), or severe lung disease
- Is elderly and residing in a nursing home, or
- Has received an organ transplant
-
Females are not eligible for this study
-
Evidence of or history of drug or alcohol abuse (within the past 6 months) or positive urine drug or alcohol screen
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety and tolerability of intranasal ALN-RSV01 versus placebo, administered in a multiple-dose schedule (once daily for 5 days) to healthy adult volunteers experimentally inoculated with respiratory syncytial virus 28 days
- Secondary Outcome Measures
Name Time Method Determining the impact of ALN-RSV01 on symptoms of RSV infection, RSV infection rate based upon measures of viral load, and understanding the potential antiviral activity of ALN-RSV01 28 days
Trial Locations
- Locations (1)
Alnylam Pharmaceuticals
🇺🇸Cambridge, Massachusetts, United States