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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

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.