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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00496821
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : November 30, 2007
Sponsor:
Information provided by:
Alnylam Pharmaceuticals

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: ALN-RSV01 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study to Investigate the Safety and Efficacy of Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
Study Start Date : July 2007
Actual Study Completion Date : November 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496821


Locations
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United States, Massachusetts
Alnylam Pharmaceuticals
Cambridge, Massachusetts, United States, 02142
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
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Study Director: Akshay Vaishnaw, MD PhD Alnylam Pharmaceuticals
More Information
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ClinicalTrials.gov Identifier: NCT00496821    
Other Study ID Numbers: ALN-RSV01-105
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: November 2007
Keywords provided by Alnylam Pharmaceuticals:
Respiratory Syncytial Virus
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Infections
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections