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

NCT00496821 | Completed Phase 2

• 1 other identifier: ALN-RSV01-105
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

ALN-RSV01 DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alnylam Pharmaceuticals: lead

Study Sites (1)

Alnylam Pharmaceuticals

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Akshay Vaishnaw, MD PhD

  Alnylam Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: July 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 30, 2007

Record last verified: 2007-11

Locations

US (1)