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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496821
• Other study ID #: ALN-RSV01-105
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2007
• Last updated: November 29, 2007
• Start date: July 2007
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: Alnylam Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• ALN-RSV01

Locations

Country	Name	City	State
United States	Alnylam Pharmaceuticals	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Alnylam Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		28 days
Secondary	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		28 days