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

NCT ID: NCT00496821

Last Updated: 2007-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2007-11-30

Brief Summary

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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

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Conditions

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Respiratory Syncytial Virus Infections

Keywords

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Respiratory Syncytial Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ALN-RSV01

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Akshay Vaishnaw, MD PhD

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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Alnylam Pharmaceuticals

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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ALN-RSV01-105

Identifier Type: -

Identifier Source: org_study_id