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

November 29, 2007 updated by: Alnylam Pharmaceuticals

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Cambridge, Massachusetts, United States, 02142
        • Alnylam Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

July 3, 2007

First Submitted That Met QC Criteria

July 3, 2007

First Posted (ESTIMATE)

July 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2007

Last Update Submitted That Met QC Criteria

November 29, 2007

Last Verified

November 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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