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

This study has been completed.
Sponsor:
Information provided by:
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00496821
First received: July 3, 2007
Last updated: November 29, 2007
Last verified: November 2007
History of Changes
  Purpose

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 Intervention Phase
Respiratory Syncytial Virus Infections
 Drug: ALN-RSV01
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alnylam Pharmaceuticals:

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 [ Time Frame: 28 days ]

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 [ Time Frame: 28 days ]

Estimated Enrollment: 88
Study Start Date: July 2007
Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496821

Locations
United States, Massachusetts
Alnylam Pharmaceuticals
Cambridge, Massachusetts, United States, 02142
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
Study Director: Akshay Vaishnaw, MD PhD Alnylam Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00496821     History of Changes
Other Study ID Numbers: ALN-RSV01-105
Study First Received: July 3, 2007
Last Updated: November 29, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Alnylam Pharmaceuticals:
Respiratory Syncytial Virus

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on May 21, 2013