A Study of ALS-008176 in Infants Hospitalized With RSV
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: Placebo
- Registration Number
- NCT02202356
- Lead Sponsor
- Alios Biopharma Inc.
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Multiple Doses Placebo Multiple doses of placebo administered orally as a suspension Placebo Single Dose Placebo Single dose of placebo administered orally as a suspension ALS-008176 Single Dose ALS-008176 Single dose of ALS-008176 administered orally as a suspension ALS-008176 Multiple Doses ALS-008176 Multiple doses of ALS-008176 administered orally as a suspension
- Primary Outcome Measures
Name Time Method Physical Examinations Baseline through 6 days post-dose Clinical Laboratory Results Baseline through 6 days post-dose Adverse Events Baseline through 6 days post-dose 12-Lead ECGs Baseline through 6 days post-dose Vital Signs Baseline through 6 days post-dose
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (77)
Children's of Alabama
🇺🇸Birmingham, Alabama, United States
Arkansas Children's Hospital Research Institute
🇺🇸Little Rock, Arkansas, United States
Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach
🇺🇸Long Beach, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
The University of California at San Diego
🇺🇸San Diego, California, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
The Children's Mercy
🇺🇸Kansas City, Missouri, United States
University of Rochester
🇺🇸Rochester, New York, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Scroll for more (67 remaining)Children's of Alabama🇺🇸Birmingham, Alabama, United States