Back to resultsA Study of ALS-008176 in Infants Hospitalized With RSV
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ALS-008176
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Syncytial Virus Infections focused on measuring RSV, Respiratory Syncytial Virus
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
Sites / Locations
- Children's of Alabama
- Arkansas Children's Hospital Research Institute
- Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach
- Children's Hospital of Orange County
- The University of California at San Diego
- LSU Health Sciences Center
- Massachusetts General Hospital
- The Children's Mercy
- University of Rochester
- The University of North Carolina at Chapel Hill
- Duke University
- The Research Institute at Nationwide Children's Hospital
- Children's Hospital/University of Tennessee
- UT Southwestern Medical Center
- Texas Children's Hospital/Baylor College of Medicine
- The University of Utah
- Seattle Children's Hospital
- The Canberra Hospital
- Monash Medical Center
- Women's and Children's Hospital
- The Royal Children's Hospital Melbourne
- Princess Margaret Hospital
- The Children's Hospital Research Institute of Manitoba
- Canadian Centre for Vaccinology IWK Health Centre
- McMaster Children's Hospital
- McGill University Health Centre
- Hospital Dr. Exequiel Gonzalez Cortes
- Complejo Asistencial Dr Sotero del Rio
- Hospital Padre Hurtado
- Fundacion Cardio Infantil Instituto de Cardiologia
- Hospital Pablo Tobon Uribe
- CHU Pellegrin / Pneumologie pediatrique
- Hopital Necker
- Hirosaki National Hospital
- Chiba Children's Hospital
- Ota Memorial Hospital
- Gunma Children's Medical Center
- NHO Fukuyama Medical Center
- Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital
- NHO Kanazawa Medical Center
- NHO Shikoku Medical Center for Children and Adults
- Okinawa Chubu Hospital
- Nakano Children's Hospital
- National Hospital Organization Saitama National Hospital
- Tokyo Metropolitan Children's Medical Center
- National Center for Child Health and Development
- Fukuoka Children's Hospital
- NHO Fukuoka Hospital
- Kochi Health Sciences Center
- Saitama Children's Medical Center
- Christchurch Clinical Study Trust
- Hawke's Bay Hospital
- Wellington Hospital
- Hospital Materno Infantil Jose Dominog de Obaldila
- Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"
- Hospital del Nino
- Institute for Mother and Child Care "Alfred Rusescu"
- 2 Military Hospital
- Kingsbury Hospital
- Tygerberg Academic Hospital
- Linkou Chang Gung Medical Hospital
- MacKay Memorial Hospital
- Chulalongkorn University Department of Pediatrics
- Phramongkutklao Hospital Department of Pediatrics
- Siriraj Hospital, Mahidol University Department of Pediatrics
- Khon Kaen University Department of Pediatrics
- Bristol Royal Hospital for Children
- Alder Hey Children's Hospital
- St. George's University of London
- University Hospital Southampton NHS Foundation Trust
- Royal Hospital for Sick Children
- Children's Hospital of Wales
- Birmingham Children's Hospital
- Royal Alexandra Children's Hospital
- Royal Manchester Children's Hospital
- Queens Medical Center
- University of Oxford
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
ALS-008176 Single Dose
Placebo Single Dose
ALS-008176 Multiple Doses
Placebo Multiple Doses
Arm Description
Single dose of ALS-008176 administered orally as a suspension
Single dose of placebo administered orally as a suspension
Multiple doses of ALS-008176 administered orally as a suspension
Multiple doses of placebo administered orally as a suspension
Outcomes
Primary Outcome Measures
Adverse Events
Physical Examinations
Vital Signs
12-Lead ECGs
Clinical Laboratory Results
Secondary Outcome Measures
RSV viral RNA concentrations in nasal aspirates
Emergence of resistance
Changes in RSV polymerase that result in reduced sensitivity to study drug
Pharmacokinetic parameters, including maximum and minimum drug concentrations
Pharmacokinetic parameters, including time to maximum concentration and half-life
Pharmacokinetic parameters, including area under concentration-time curves (AUCs)
Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02202356
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 23, 2014 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
February 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alios Biopharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
RSV, Respiratory Syncytial Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALS-008176 Single Dose
Arm Type
Experimental
Arm Description
Single dose of ALS-008176 administered orally as a suspension
Arm Title
Placebo Single Dose
Arm Type
Placebo Comparator
Arm Description
Single dose of placebo administered orally as a suspension
Arm Title
ALS-008176 Multiple Doses
Arm Type
Experimental
Arm Description
Multiple doses of ALS-008176 administered orally as a suspension
Arm Title
Placebo Multiple Doses
Arm Type
Placebo Comparator
Arm Description
Multiple doses of placebo administered orally as a suspension
Intervention Type
Drug
Intervention Name(s)
ALS-008176
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
Baseline through 6 days post-dose
Title
Physical Examinations
Time Frame
Baseline through 6 days post-dose
Title
Vital Signs
Time Frame
Baseline through 6 days post-dose
Title
12-Lead ECGs
Time Frame
Baseline through 6 days post-dose
Title
Clinical Laboratory Results
Time Frame
Baseline through 6 days post-dose
Secondary Outcome Measure Information:
Title
RSV viral RNA concentrations in nasal aspirates
Time Frame
Baseline through 6 days post-dose
Title
Emergence of resistance
Description
Changes in RSV polymerase that result in reduced sensitivity to study drug
Time Frame
Baseline through 6 days post-dose
Title
Pharmacokinetic parameters, including maximum and minimum drug concentrations
Time Frame
Baseline through 6 days post-dose
Title
Pharmacokinetic parameters, including time to maximum concentration and half-life
Time Frame
Baseline through 6 days post-dose
Title
Pharmacokinetic parameters, including area under concentration-time curves (AUCs)
Time Frame
Baseline through 6 days post-dose
Title
Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)
Time Frame
Baseline through 6 days post-dose
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew McClure, M.D.
Organizational Affiliation
Alios BioPharma
Official's Role
Study Director
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
The University of California at San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
The Children's Mercy
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14611
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
The Research Institute at Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Hospital/University of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Children's Hospital/Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
The Canberra Hospital
City
Canberra
Country
Australia
Facility Name
Monash Medical Center
City
Melbourne
Country
Australia
Facility Name
Women's and Children's Hospital
City
North Adelaide
Country
Australia
Facility Name
The Royal Children's Hospital Melbourne
City
Parkville
Country
Australia
Facility Name
Princess Margaret Hospital
City
Perth
Country
Australia
Facility Name
The Children's Hospital Research Institute of Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Canadian Centre for Vaccinology IWK Health Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hospital Dr. Exequiel Gonzalez Cortes
City
San Miguel
State/Province
Santiago
Country
Chile
Facility Name
Complejo Asistencial Dr Sotero del Rio
City
Santiago
Country
Chile
Facility Name
Hospital Padre Hurtado
City
Santiago
Country
Chile
Facility Name
Fundacion Cardio Infantil Instituto de Cardiologia
City
Bogota
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
Country
Colombia
Facility Name
CHU Pellegrin / Pneumologie pediatrique
City
Bordeaux
Country
France
Facility Name
Hopital Necker
City
Paris
Country
France
Facility Name
Hirosaki National Hospital
City
Hirosaki-shi
State/Province
Aomori
Country
Japan
Facility Name
Chiba Children's Hospital
City
Chiba-shi
State/Province
Chiba
Country
Japan
Facility Name
Ota Memorial Hospital
City
Ota
State/Province
Gunma
ZIP/Postal Code
373-8585
Country
Japan
Facility Name
Gunma Children's Medical Center
City
Shibukawa-shi
State/Province
Gunma
Country
Japan
Facility Name
NHO Fukuyama Medical Center
City
Fukuyama
State/Province
Hiroshima
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital
City
Asahikawa-shi
State/Province
Hokkaido
Country
Japan
Facility Name
NHO Kanazawa Medical Center
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
NHO Shikoku Medical Center for Children and Adults
City
Takamatsu
State/Province
Kagawa
Country
Japan
Facility Name
Okinawa Chubu Hospital
City
Urumi
State/Province
Okinawa
Country
Japan
Facility Name
Nakano Children's Hospital
City
Osaka-city
State/Province
Osaka
Country
Japan
Facility Name
National Hospital Organization Saitama National Hospital
City
Wako
State/Province
Saitama
ZIP/Postal Code
351-0102
Country
Japan
Facility Name
Tokyo Metropolitan Children's Medical Center
City
Fuchu-shi
State/Province
Tokyo
Country
Japan
Facility Name
National Center for Child Health and Development
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Fukuoka Children's Hospital
City
Fukuoka
Country
Japan
Facility Name
NHO Fukuoka Hospital
City
Fukuoka
Country
Japan
Facility Name
Kochi Health Sciences Center
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
Saitama Children's Medical Center
City
Saitama
Country
Japan
Facility Name
Christchurch Clinical Study Trust
City
Christchurch
Country
New Zealand
Facility Name
Hawke's Bay Hospital
City
Hastings
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
Country
New Zealand
Facility Name
Hospital Materno Infantil Jose Dominog de Obaldila
City
David
State/Province
Chiriqui
Country
Panama
Facility Name
Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"
City
Panama City
Country
Panama
Facility Name
Hospital del Nino
City
Panama City
Country
Panama
Facility Name
Institute for Mother and Child Care "Alfred Rusescu"
City
Bucharest
Country
Romania
Facility Name
2 Military Hospital
City
Cape Town
Country
South Africa
Facility Name
Kingsbury Hospital
City
Cape Town
Country
South Africa
Facility Name
Tygerberg Academic Hospital
City
Cape Town
Country
South Africa
Facility Name
Linkou Chang Gung Medical Hospital
City
Taipei
Country
Taiwan
Facility Name
MacKay Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
Chulalongkorn University Department of Pediatrics
City
Bangkok
Country
Thailand
Facility Name
Phramongkutklao Hospital Department of Pediatrics
City
Bangkok
Country
Thailand
Facility Name
Siriraj Hospital, Mahidol University Department of Pediatrics
City
Bangkok
Country
Thailand
Facility Name
Khon Kaen University Department of Pediatrics
City
Khon Kaen
Country
Thailand
Facility Name
Bristol Royal Hospital for Children
City
Bristol
State/Province
England
Country
United Kingdom
Facility Name
Alder Hey Children's Hospital
City
Liverpool
State/Province
England
Country
United Kingdom
Facility Name
St. George's University of London
City
London
State/Province
England
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
England
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
Country
United Kingdom
Facility Name
Children's Hospital of Wales
City
Cardiff
State/Province
Wales
Country
United Kingdom
Facility Name
Birmingham Children's Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Royal Alexandra Children's Hospital
City
Brighton
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
Country
United Kingdom
Facility Name
Queens Medical Center
City
Nottingham
Country
United Kingdom
Facility Name
University of Oxford
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of ALS-008176 in Infants Hospitalized With RSV
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