Respiratory Syncytial Virus Infections
Conditions
Keywords
RSV, Respiratory Syncytial Virus
Brief summary
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)
Interventions
DRUGALS-008176
DRUGPlacebo
Sponsors
Alios Biopharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| RSV viral RNA concentrations in nasal aspirates | 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 | — |
| Emergence of resistance | Baseline through 6 days post-dose | Changes in RSV polymerase that result in reduced sensitivity to study drug |
| 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 | — |
Countries
Australia, Canada, Chile, Colombia, France, Japan, New Zealand, Panama, Romania, South Africa, Taiwan, Thailand, United Kingdom, United States
Outcome results
None listed