Intranasal ALN-RSV01 Administered to Adult Volunteers Exp... | NCT00496821

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

NCT00496821

Sponsor

Alnylam Pharmaceuticals

Status

Completed

Last Update Posted

Nov 30, 2007Estimated

Enrollment

88Estimated

Phase

Phase 2

Conditions

Respiratory Syncytial Virus Infections

Interventions

ALN-RSV01

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Not provided

Completion Date

Nov 2007Actual

First Submitted Date

Jul 3, 2007

First Submission Date that Met QC Criteria

Jul 3, 2007

First Posted Date

Jul 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2007

Last Update Posted Date

Nov 30, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Name	Type	Description	Arm Group Labels	Other Names
ALN-RSV01	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections