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

Sponsored by:	Alnylam Pharmaceuticals
Information provided by:	Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00496821

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 II

MedlinePlus related topics: Respiratory Syncytial Virus Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Investigate the Safety and Efficacy of Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus

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

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

Keywords provided by Alnylam Pharmaceuticals:

Respiratory Syncytial Virus

Study placed in the following topic categories:

Virus Diseases
Paramyxoviridae Infections
Respiratory Syncytial Virus Infections

Additional relevant MeSH terms:

RNA Virus Infections
Pneumovirus Infections
Infection
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 16, 2009