Clinical trial NCT02202356: A Study of ALS-008176 in Infants Hospitalized With RSV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: RSV
Respiratory Syncytial Virus
Lead sponsor: Alios Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 183
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: Baseline through 6 days post-dose
measure: Physical Examinations
timeFrame: Baseline through 6 days post-dose
measure: Vital Signs
timeFrame: Baseline through 6 days post-dose
measure: 12-Lead ECGs
timeFrame: Baseline through 6 days post-dose
measure: Clinical Laboratory Results
timeFrame: Baseline through 6 days post-dose
Secondary outcomes:
measure: RSV viral RNA concentrations in nasal aspirates
timeFrame: Baseline through 6 days post-dose
measure: Emergence of resistance
timeFrame: Baseline through 6 days post-dose
measure: Pharmacokinetic parameters, including maximum and minimum drug concentrations
timeFrame: Baseline through 6 days post-dose
measure: Pharmacokinetic parameters, including time to maximum concentration and half-life
timeFrame: Baseline through 6 days post-dose
measure: Pharmacokinetic parameters, including area under concentration-time curves (AUCs)
timeFrame: Baseline through 6 days post-dose
measure: Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)
timeFrame: Baseline through 6 days post-dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: San Diego
country: United States
facility: The University of California at San Diego
state: California
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: The Children's Mercy
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: The Research Institute at Nationwide Children's Hospital
state: Ohio
city: Memphis
country: United States
facility: Children's Hospital/University of Tennessee
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital/Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Canberra
country: Australia
facility: The Canberra Hospital
city: Melbourne
country: Australia
facility: Monash Medical Center
city: North Adelaide
country: Australia
facility: Women's and Children's Hospital
city: Parkville
country: Australia
facility: The Royal Children's Hospital Melbourne
city: Perth
country: Australia
facility: Princess Margaret Hospital
city: Winnipeg
country: Canada
facility: The Children's Hospital Research Institute of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Canadian Centre for Vaccinology IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: San Miguel
country: Chile
facility: Hospital Dr. Exequiel Gonzalez Cortes
state: Santiago
city: Santiago
country: Chile
facility: Complejo Asistencial Dr Sotero del Rio
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
city: Bogota
country: Colombia
facility: Fundacion Cardio Infantil Instituto de Cardiologia
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Bordeaux
country: France
facility: CHU Pellegrin / Pneumologie pediatrique
city: Paris
country: France
facility: Hopital Necker
city: Hirosaki-shi
country: Japan
facility: Hirosaki National Hospital
state: Aomori
city: Chiba-shi
country: Japan
facility: Chiba Children's Hospital
state: Chiba
city: Ota
country: Japan
facility: Ota Memorial Hospital
state: Gunma
city: Shibukawa-shi
country: Japan
facility: Gunma Children's Medical Center
state: Gunma
city: Fukuyama
country: Japan
facility: NHO Fukuyama Medical Center
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: NHO Kanazawa Medical Center
state: Ishikawa
city: Takamatsu
country: Japan
facility: NHO Shikoku Medical Center for Children and Adults
state: Kagawa
city: Urumi
country: Japan
facility: Okinawa Chubu Hospital
state: Okinawa
city: Osaka-city
country: Japan
facility: Nakano Children's Hospital
state: Osaka
city: Wako
country: Japan
facility: National Hospital Organization Saitama National Hospital
state: Saitama
city: Fuchu-shi
country: Japan
facility: Tokyo Metropolitan Children's Medical Center
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka Children's Hospital
city: Fukuoka
country: Japan
facility: NHO Fukuoka Hospital
city: Kochi
country: Japan
facility: Kochi Health Sciences Center
city: Saitama
country: Japan
facility: Saitama Children's Medical Center
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Study Trust
city: Hastings
country: New Zealand
facility: Hawke's Bay Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: David
country: Panama
facility: Hospital Materno Infantil Jose Dominog de Obaldila
state: Chiriqui
city: Panama City
country: Panama
facility: Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"
city: Panama City
country: Panama
facility: Hospital del Nino
city: Bucharest
country: Romania
facility: Institute for Mother and Child Care "Alfred Rusescu"
city: Cape Town
country: South Africa
facility: 2 Military Hospital
city: Cape Town
country: South Africa
facility: Kingsbury Hospital
city: Cape Town
country: South Africa
facility: Tygerberg Academic Hospital
city: Taipei
country: Taiwan
facility: Linkou Chang Gung Medical Hospital
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn University Department of Pediatrics
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital Department of Pediatrics
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University Department of Pediatrics
city: Khon Kaen
country: Thailand
facility: Khon Kaen University Department of Pediatrics
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
state: England
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
state: England
city: London
country: United Kingdom
facility: St. George's University of London
state: England
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: England
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Cardiff
country: United Kingdom
facility: Children's Hospital of Wales
state: Wales
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Brighton
country: United Kingdom
facility: Royal Alexandra Children's Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Nottingham
country: United Kingdom
facility: Queens Medical Center
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: Alios BioPharma
name: Matthew McClure, M.D.
role: STUDY_DIRECTOR
References: