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

Tracking Information

First Received Date ^ICMJE

July 3, 2007

Last Updated Date

November 29, 2007

Start Date ^ICMJE

July 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00496821 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Study to Investigate the Safety and Efficacy of Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Respiratory Syncytial Virus Infections

Intervention ^ICMJE

Drug: ALN-RSV01

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00496821

Responsible Party

Study ID Numbers ^ICMJE

ALN-RSV01-105

Study Sponsor ^ICMJE

Alnylam Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Akshay Vaishnaw, MD PhD

Alnylam Pharmaceuticals

Information Provided By

Alnylam Pharmaceuticals

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP