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Completed

NCT Number: NCT00496821

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

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

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Alnylam Pharmaceuticals

Cambridge, Massachusetts, 02142, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALN-RSV01

Drug

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

    Time frame: 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

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2007
First posted
Jul 4, 2007
Registry last updated
Nov 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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