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

Completed · Phase 2

Conditions studied: Respiratory Syncytial Virus Infections

In brief

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

Key facts

Study ID

NCT00496821

Run by

Alnylam Pharmaceuticals

People needed

88

Starts

2007-07-01

Expected to finish

2007-11-01

Last updated by the study team

2007-11-30

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alnylam Pharmaceuticals — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.