Experimentally induced Respiratory Syncytial Virus infection. The experimental infectious dose has been titrated in a previous study in healthy volunteers. MedDRA version: 9.1 Level: LLT Classification code 10052200 Term: Respiratory syncytial virus infection NOS
Conditions
Interventions
Product Name: ALN-RSV01
Pharmaceutical Form: Nasal spray, solution
Pharmaceutical form of the placebo: Nasal spray, solution
Route of administration of the placebo: Intranasal use (Noncurrent)
Sponsors
Alnylam Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males 18 to 45 years of age, inclusive. 2. Availability for the required study period (including the inpatient quarantine phase), ability to comply with study requirements, and ability to attend the scheduled inpatient (quarantine) and follow-up study visits. 3. 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. 4. 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 quarantine unit. 5. Agreement to use condoms as a barrier method of birth control for any sexual contact for 30 days after the last dose of study medication. 6. Has a body mass index (BMI) greater than 18.0 and that is considered by the Investigator as clinically acceptable for the subject. 7. Low titers of RSV neutralizing antibody measured during Screen. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Females are not eligible for this study. 2. Positive serologic test for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C antibody positive. 3. Evidence of or history of drug or alcohol abuse (within the past 6 months) or a positive urine drug or alcohol screen. 4. An abnormal ECG deemed clinically relevant by the PI. 5. Subjects unable or unwilling to refrain from smoking or using tobacco products during the quarantine period 6. Has current seasonal allergic rhinitis (SAR), or recent viral rhinitis within 4 weeks prior to study drug administration. 7. Allergy to gentamycin or other aminoglycoside antibiotics. 8. Has any nasopharyngeal abnormality that may interfere with absorption, distribution, or study-related evaluations as judged by the PI 9. Presence of household member or close contact to someone who a. is less than three (3) years of age b. has a known immunodeficiency c. is receiving immunosuppressant drugs d. is undergoing or soon to undergo cancer chemotherapy within 28 days of challenge e. has diagnosed emphysema, chronic obstructive pulmonary disease (COPD), or severe lung disease f. is elderly and residing in a nursing home, or g. has received an organ transplant. 10. Any laboratory test which is abnormal and deemed by the investigator to be clinically significant. (This includes blood chemistry, hematology, or urinalysis). 11. Presence of any febrile illness or symptoms suggestive of viral respiratory infection within 4 weeks prior to challenge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the 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 (RSV). ;Secondary Objective: Determination of the the impact of ALN-RSV01 on symptoms of RSV infection, RSV infection rate based on measures of viral load, and understanding the potential antiviral activity of ALN-RSV01. ;Primary end point(s): Safety endpoints will evaluate the tolerability of ALN-RSV01 relative to placebo in RSV-exposed individuals, and will include the following: • Frequency and severity of treatment related adverse events • Treatment-related changes in vital signs • Treatment-related changes in physical examination (PE) findings • Treatment-related changes in nasal examination findings • Treatment-related changes in electrocardiogram (ECG) parameters • Treatment-related changes in clinical laboratory assessments. Efficacy endpoints are exploratory and may include • Changes in symptoms of RSV infection • Frequency of RSV infection, expressed as the percentage of subjects developing infection after inoculation. • Assessment of RSV viral load a. Peak amount of viral load b. Time to peak viral load c. Mean daily viral load d. Duration of viral shedding e. Overall viral load (based on the area under the concentration-time curve [AUC]) • Serum RSV antibody response | — |
Countries
United Kingdom
Outcome results
None listed