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

Alnylam Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Respiratory Syncytial Virus Infections

Treatments

Drug: ALN-RSV01

Study type

Interventional

Funder types

Industry

Identifiers

NCT00496821

ALN-RSV01-105

Details and patient eligibility

About

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

Enrollment

88 estimated patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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