A Study of ALS-008176 in Infants Hospitalized With RSV

Study Overview
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Brief Summary
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This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)

Official Title
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A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Drug: ALS-008176
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female infant who is ≥1.0 to ≤12.0 months of age (inclusive), defined at the time of hospital admission, or <28 days of age (neonate cohort only). Note: all subjects, including neonates, must have been discharged from the hospital after birth and are now being admitted due to an RSV related illness Exclusion Criteria: Prematurity Receiving invasive endotracheal mechanical ventilation Poorly functioning gastrointestinal tract Anticipated to be discharged from the hospital in <24 hours from the time of randomization Prior exposure to palivizumab

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALS-008176 Single Dose<br>Single dose of ALS-008176 administered orally as a suspension | Drug: ALS-008176<br> <br> |
| Placebo Comparator: Placebo Single Dose<br>Single dose of placebo administered orally as a suspension | Drug: Placebo<br> <br> |
| Experimental: ALS-008176 Multiple Doses<br>Multiple doses of ALS-008176 administered orally as a suspension | Drug: ALS-008176<br> <br> |
| Placebo Comparator: Placebo Multiple Doses<br>Multiple doses of placebo administered orally as a suspension | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Baseline through 6 days post-dose | 
| Physical Examinations |  | Baseline through 6 days post-dose | 
| Vital Signs |  | Baseline through 6 days post-dose | 
| 12-Lead ECGs |  | Baseline through 6 days post-dose | 
| Clinical Laboratory Results |  | Baseline through 6 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RSV viral RNA concentrations in nasal aspirates |  | Baseline through 6 days post-dose | 
| Emergence of resistance | Changes in RSV polymerase that result in reduced sensitivity to study drug | Baseline through 6 days post-dose | 
| Pharmacokinetic parameters, including maximum and minimum drug concentrations |  | Baseline through 6 days post-dose | 
| Pharmacokinetic parameters, including time to maximum concentration and half-life |  | Baseline through 6 days post-dose | 
| Pharmacokinetic parameters, including area under concentration-time curves (AUCs) |  | Baseline through 6 days post-dose | 
| Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F) |  | Baseline through 6 days post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Syncytial Virus, RSV