Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
183 participants
INTERVENTIONAL
2014-07-23
2018-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
NCT00496821
A Study to Investigate the Safety and Tolerability of Single and Repeat Doses of PC786
NCT03236233
A Study of AK0529 in Chinese Infants Hospitalized With RSV
NCT04231968
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
NCT04583280
Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017)
NCT05559905
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ALS-008176 Single Dose
Single dose of ALS-008176 administered orally as a suspension
ALS-008176
Placebo Single Dose
Single dose of placebo administered orally as a suspension
Placebo
ALS-008176 Multiple Doses
Multiple doses of ALS-008176 administered orally as a suspension
ALS-008176
Placebo Multiple Doses
Multiple doses of placebo administered orally as a suspension
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ALS-008176
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
12 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alios Biopharma Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthew McClure, M.D.
Role: STUDY_DIRECTOR
Alios BioPharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Duke University
Durham, North Carolina, United States
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital/University of Tennessee
Memphis, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, United States
The University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, 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, 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, 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, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-005104-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALS-8176-503
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.