Title
Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
A Study to Investigate the Safety and Efficacy of Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
Phase
Phase 2Lead Sponsor
Alnylam PharmaceuticalsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Respiratory Syncytial Virus InfectionsIntervention/Treatment
aln-rsv01 ...Study Participants
88The 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
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.
