Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus

Study Overview
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Brief Summary
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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

Official Title
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A Study to Investigate the Safety and Efficacy of Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Drug: ALN-RSV01


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALN-RSV01|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Syncytial Virus