Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory Syncytial Virus
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
Interventions
DRUGALN-RSV01
Sponsors
Alnylam Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed