Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by:
Alnylam Pharmaceuticals Identifier:
First received: July 3, 2007
Last updated: November 29, 2007
Last verified: November 2007

July 3, 2007
November 29, 2007
July 2007
Not Provided
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 [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT00496821 on Archive Site
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 [ Time Frame: 28 days ]
Same as current
Not Provided
Not Provided
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
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
Not Provided
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Respiratory Syncytial Virus Infections
Drug: ALN-RSV01
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2007
Not Provided

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.

18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Alnylam Pharmaceuticals
Not Provided
Study Director: Akshay Vaishnaw, MD PhD Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP