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

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALN-RSV01
Sponsored by
Alnylam Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory Syncytial Virus

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Alnylam Pharmaceuticals

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 3, 2007
Last Updated
November 29, 2007
Sponsor
Alnylam Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00496821
Brief Title
Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
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 Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alnylam Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Respiratory Syncytial Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ALN-RSV01
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akshay Vaishnaw, MD PhD
Organizational Affiliation
Alnylam Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Alnylam Pharmaceuticals
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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