A Study of ALS-008176 in Infants Hospitalized With RSV
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
2 other identifiers
interventional
183
14 countries
77
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2014
Typical duration for phase_1
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2014
CompletedStudy Start
First participant enrolled
July 23, 2014
CompletedFirst Posted
Study publicly available on registry
July 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2018
CompletedFebruary 3, 2025
January 1, 2025
3.6 years
July 23, 2014
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (6)
RSV viral RNA concentrations in nasal aspirates
Baseline through 6 days post-dose
Emergence of resistance
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
- +1 more secondary outcomes
Study Arms (4)
ALS-008176 Single Dose
EXPERIMENTALSingle dose of ALS-008176 administered orally as a suspension
Placebo Single Dose
PLACEBO COMPARATORSingle dose of placebo administered orally as a suspension
ALS-008176 Multiple Doses
EXPERIMENTALMultiple doses of ALS-008176 administered orally as a suspension
Placebo Multiple Doses
PLACEBO COMPARATORMultiple doses of placebo administered orally as a suspension
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
Children's of Alabama
Birmingham, Alabama, 35233, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202, United States
Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach
Long Beach, California, 90806, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
The University of California at San Diego
San Diego, California, 92093, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
The Children's Mercy
Kansas City, Missouri, 64108, United States
University of Rochester
Rochester, New York, 14611, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27708, United States
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital/University of Tennessee
Memphis, Tennessee, 38103, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030, United States
The University of Utah
Salt Lake City, Utah, 84112, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
The Canberra Hospital
Canberra, Australia
Monash Medical Center
Melbourne, Australia
Women's and Children's Hospital
North Adelaide, Australia
The Royal Children's Hospital Melbourne
Parkville, Australia
Princess Margaret Hospital
Perth, Australia
The Children's Hospital Research Institute of Manitoba
Winnipeg, Manitoba, Canada
Canadian Centre for Vaccinology IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hospital Dr. Exequiel Gonzalez Cortes
San Miguel, Santiago Metropolitan, Chile
Complejo Asistencial Dr Sotero del Rio
Santiago, Chile
Hospital Padre Hurtado
Santiago, Chile
Fundacion Cardio Infantil Instituto de Cardiologia
Bogotá, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
CHU Pellegrin / Pneumologie pediatrique
Bordeaux, France
Hopital Necker
Paris, France
Hirosaki National Hospital
Hirosaki-shi, Aomori, Japan
Chiba Children's Hospital
Chiba, Chiba, Japan
Ota Memorial Hospital
Ōta, Gunma, 373-8585, Japan
Gunma Children's Medical Center
Shibukawa-shi, Gunma, Japan
NHO Fukuyama Medical Center
Fukuyama, Hiroshima, Japan
Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital
Asahikawa-shi, Hokkaido, Japan
NHO Kanazawa Medical Center
Kanazawa, Ishikawa-ken, Japan
NHO Shikoku Medical Center for Children and Adults
Takamatsu, Kagawa-ken, Japan
Okinawa Chubu Hospital
Urumi, Okinawa, Japan
Nakano Children's Hospital
Osaka, Osaka, Japan
National Hospital Organization Saitama National Hospital
Wako, Saitama, 351-0102, Japan
Tokyo Metropolitan Children's Medical Center
Fuchu-shi, Tokyo, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan
Fukuoka Children's Hospital
Fukuoka, Japan
NHO Fukuoka Hospital
Fukuoka, Japan
Kochi Health Sciences Center
Kochi, 781-8555, Japan
Saitama Children's Medical Center
Saitama, Japan
Christchurch Clinical Study Trust
Christchurch, New Zealand
Hawke's Bay Hospital
Hastings, New Zealand
Wellington Hospital
Wellington, New Zealand
Hospital Materno Infantil Jose Dominog de Obaldila
David, Chiriquí Province, Panama
Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"
Panama City, Panama
Hospital del Nino
Panama City, Panama
Institute for Mother and Child Care "Alfred Rusescu"
Bucharest, Romania
2 Military Hospital
Cape Town, South Africa
Kingsbury Hospital
Cape Town, South Africa
Tygerberg Academic Hospital
Cape Town, South Africa
Linkou Chang Gung Medical Hospital
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
Chulalongkorn University Department of Pediatrics
Bangkok, Thailand
Phramongkutklao Hospital Department of Pediatrics
Bangkok, Thailand
Siriraj Hospital, Mahidol University Department of Pediatrics
Bangkok, Thailand
Khon Kaen University Department of Pediatrics
Khon Kaen, Thailand
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Alder Hey Children's Hospital
Liverpool, England, United Kingdom
St. George's University of London
London, England, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, England, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Children's Hospital of Wales
Cardiff, Wales, United Kingdom
Birmingham Children's Hospital
Birmingham, United Kingdom
Royal Alexandra Children's Hospital
Brighton, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
Queens Medical Center
Nottingham, United Kingdom
University of Oxford
Oxford, United Kingdom
Related Publications (1)
Oey A, McClure M, Symons JA, Chanda S, Fry J, Smith PF, Luciani K, Fayon M, Chokephaibulkit K, Uppala R, Bernatoniene J, Furuno K, Stanley T, Huntjens D, Witek J; 503 and RSV2004 Study Groups. Lumicitabine, an orally administered nucleoside analog, in infants hospitalized with respiratory syncytial virus (RSV) infection: Safety, efficacy, and pharmacokinetic results. PLoS One. 2023 Jul 19;18(7):e0288271. doi: 10.1371/journal.pone.0288271. eCollection 2023.
PMID: 37467213DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Matthew McClure, M.D.
Alios BioPharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2014
First Posted
July 29, 2014
Study Start
July 23, 2014
Primary Completion
February 15, 2018
Study Completion
February 15, 2018
Last Updated
February 3, 2025
Record last verified: 2025-01