A Study of ALS-008176 in Infants Hospitalized With RSV
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: PlaceboDrug: ALS-008176
- 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)
The Research Institute at Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
The Canberra Hospital
🇦🇺Canberra, Australia
Princess Margaret Hospital
🇦🇺Perth, Australia
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Texas Children's Hospital/Baylor College of Medicine
🇺🇸Houston, Texas, United States
Monash Medical Center
🇦🇺Melbourne, Australia
Women's and Children's Hospital
🇦🇺North Adelaide, Australia
The Royal Children's Hospital Melbourne
🇦🇺Parkville, Australia
Hawke's Bay Hospital
🇳🇿Hastings, New Zealand
Queens Medical Center
🇬🇧Nottingham, United Kingdom
Kingsbury Hospital
🇿🇦Cape Town, South Africa
Royal Alexandra Children's Hospital
🇬🇧Brighton, United Kingdom
Christchurch Clinical Study Trust
🇳🇿Christchurch, New Zealand
Wellington Hospital
🇳🇿Wellington, New Zealand
Birmingham Children's Hospital
🇬🇧Birmingham, United Kingdom
Saitama Children's Medical Center
🇯🇵Saitama, Japan
University of Oxford
🇬🇧Oxford, United Kingdom
The University of California at San Diego
🇺🇸San Diego, California, United States
Duke University
🇺🇸Durham, North Carolina, United States
The Children's Hospital Research Institute of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Children's of Alabama
🇺🇸Birmingham, Alabama, United States
Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach
🇺🇸Long Beach, California, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
University of Rochester
🇺🇸Rochester, New York, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
CHU Pellegrin / Pneumologie pediatrique
🇫🇷Bordeaux, France
Hopital Necker
🇫🇷Paris, France
Royal Manchester Children's Hospital
🇬🇧Manchester, United Kingdom
Hospital Dr. Exequiel Gonzalez Cortes
🇨🇱San Miguel, Santiago, Chile
Gunma Children's Medical Center
🇯🇵Shibukawa-shi, Gunma, Japan
NHO Fukuyama Medical Center
🇯🇵Fukuyama, Hiroshima, Japan
Kochi Health Sciences Center
🇯🇵Kochi, Japan
Institute for Mother and Child Care "Alfred Rusescu"
🇷🇴Bucharest, Romania
Royal Hospital for Sick Children
🇬🇧Edinburgh, Scotland, United Kingdom
Children's Hospital/University of Tennessee
🇺🇸Memphis, Tennessee, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Complejo Asistencial Dr Sotero del Rio
🇨🇱Santiago, Chile
Fundacion Cardio Infantil Instituto de Cardiologia
🇨🇴Bogota, Colombia
Hospital Pablo Tobon Uribe
🇨🇴Medellin, Colombia
The University of Utah
🇺🇸Salt Lake City, Utah, United States
St. George's University of London
🇬🇧London, England, United Kingdom
Hirosaki National Hospital
🇯🇵Hirosaki-shi, Aomori, Japan
NHO Shikoku Medical Center for Children and Adults
🇯🇵Takamatsu, Kagawa, Japan
Fukuoka Children's Hospital
🇯🇵Fukuoka, Japan
Hospital Materno Infantil Jose Dominog de Obaldila
🇵🇦David, Chiriqui, Panama
Chulalongkorn University Department of Pediatrics
🇹🇭Bangkok, Thailand
Canadian Centre for Vaccinology IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
National Center for Child Health and Development
🇯🇵Setagaya-ku, Tokyo, Japan
MacKay Memorial Hospital
🇨🇳Taipei, Taiwan
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, England, United Kingdom
Children's Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Hospital Padre Hurtado
🇨🇱Santiago, Chile
Chiba Children's Hospital
🇯🇵Chiba-shi, Chiba, Japan
Ota Memorial Hospital
🇯🇵Ota, Gunma, Japan
Okinawa Chubu Hospital
🇯🇵Urumi, Okinawa, Japan
Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"
🇵🇦Panama City, Panama
Phramongkutklao Hospital Department of Pediatrics
🇹🇭Bangkok, Thailand
Khon Kaen University Department of Pediatrics
🇹🇭Khon Kaen, Thailand
Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital
🇯🇵Asahikawa-shi, Hokkaido, Japan
NHO Kanazawa Medical Center
🇯🇵Kanazawa, Ishikawa, Japan
Tokyo Metropolitan Children's Medical Center
🇯🇵Fuchu-shi, Tokyo, Japan
Nakano Children's Hospital
🇯🇵Osaka-city, Osaka, Japan
National Hospital Organization Saitama National Hospital
🇯🇵Wako, Saitama, Japan
Hospital del Nino
🇵🇦Panama City, Panama
Linkou Chang Gung Medical Hospital
🇨🇳Taipei, Taiwan
Alder Hey Children's Hospital
🇬🇧Liverpool, England, United Kingdom
NHO Fukuoka Hospital
🇯🇵Fukuoka, Japan
Siriraj Hospital, Mahidol University Department of Pediatrics
🇹🇭Bangkok, Thailand
The Children's Mercy
🇺🇸Kansas City, Missouri, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
2 Military Hospital
🇿🇦Cape Town, South Africa
Tygerberg Academic Hospital
🇿🇦Cape Town, South Africa
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Arkansas Children's Hospital Research Institute
🇺🇸Little Rock, Arkansas, United States
Bristol Royal Hospital for Children
🇬🇧Bristol, England, United Kingdom