A Study of ALS-008176 in Infants Hospitalized With RSV

April 3, 2019 updated by: Alios Biopharma Inc.

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Canberra, Australia
        • The Canberra Hospital
      • Melbourne, Australia
        • Monash Medical Center
      • North Adelaide, Australia
        • Women's and Children's Hospital
      • Parkville, Australia
        • The Royal Children's Hospital Melbourne
      • Perth, Australia
        • Princess Margaret Hospital
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • The Children's Hospital Research Institute of Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Canadian Centre for Vaccinology IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster Children's Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • McGill University Health Centre
  • Chile
      • Santiago, Chile
        • Hospital Padre Hurtado
      • Santiago, Chile
        • Complejo Asistencial Dr Sotero del Rio
    • Santiago
      • San Miguel, Santiago, Chile
        • Hospital Dr. Exequiel Gonzalez Cortes
  • Colombia
      • Bogota, Colombia
        • Fundacion Cardio Infantil Instituto de Cardiologia
      • Medellin, Colombia
        • Hospital Pablo Tobon Uribe
  • France
      • Bordeaux, France
        • CHU Pellegrin / Pneumologie pediatrique
      • Paris, France
        • Hôpital Necker
  • Japan
      • Fukuoka, Japan
        • Fukuoka Children's Hospital
      • Fukuoka, Japan
        • NHO Fukuoka Hospital
      • Kochi, Japan, 781-8555
        • Kochi Health Sciences Center
      • Saitama, Japan
        • Saitama Children's Medical Center
    • Aomori
      • Hirosaki-shi, Aomori, Japan
        • Hirosaki National Hospital
    • Chiba
      • Chiba-shi, Chiba, Japan
        • Chiba Children's Hospital
    • Gunma
      • Ota, Gunma, Japan, 373-8585
        • Ota Memorial Hospital
      • Shibukawa-shi, Gunma, Japan
        • Gunma Children's Medical Center
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • NHO Fukuyama Medical Center
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan
        • Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
        • NHO Kanazawa Medical Center
    • Kagawa
      • Takamatsu, Kagawa, Japan
        • NHO Shikoku Medical Center for Children and Adults
    • Okinawa
      • Urumi, Okinawa, Japan
        • Okinawa Chubu Hospital
    • Osaka
      • Osaka-city, Osaka, Japan
        • Nakano Children's Hospital
    • Saitama
      • Wako, Saitama, Japan, 351-0102
        • National Hospital Organization Saitama National Hospital
    • Tokyo
      • Fuchu-shi, Tokyo, Japan
        • Tokyo Metropolitan Children's Medical Center
      • Setagaya-ku, Tokyo, Japan
        • National Center for Child Health and Development
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Clinical Study Trust
      • Hastings, New Zealand
        • Hawke's Bay Hospital
      • Wellington, New Zealand
        • Wellington Hospital
  • Panama
      • Panama City, Panama
        • Hospital del Nino
      • Panama City, Panama
        • Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"
    • Chiriqui
      • David, Chiriqui, Panama
        • Hospital Materno Infantil Jose Dominog de Obaldila
  • Romania
      • Bucharest, Romania
        • Institute for Mother and Child Care "Alfred Rusescu"
  • South Africa
      • Cape Town, South Africa
        • Kingsbury Hospital
      • Cape Town, South Africa
        • 2 Military Hospital
      • Cape Town, South Africa
        • Tygerberg Academic Hospital
  • Taiwan
      • Taipei, Taiwan
        • Mackay Memorial Hospital
      • Taipei, Taiwan
        • Linkou Chang Gung Medical Hospital
  • Thailand
      • Bangkok, Thailand
        • Chulalongkorn University Department of Pediatrics
      • Bangkok, Thailand
        • Phramongkutklao Hospital Department of Pediatrics
      • Bangkok, Thailand
        • Siriraj Hospital, Mahidol University Department of Pediatrics
      • Khon Kaen, Thailand
        • Khon Kaen University Department of Pediatrics
  • United Kingdom
      • Birmingham, United Kingdom
        • Birmingham Children's Hospital
      • Brighton, United Kingdom
        • Royal Alexandra Children's Hospital
      • Manchester, United Kingdom
        • Royal Manchester Children's Hospital
      • Nottingham, United Kingdom
        • Queens Medical Center
      • Oxford, United Kingdom
        • University of Oxford
    • England
      • Bristol, England, United Kingdom
        • Bristol Royal Hospital for Children
      • Liverpool, England, United Kingdom
        • Alder Hey Children's Hospital
      • London, England, United Kingdom
        • St. George's University of London
      • Southampton, England, United Kingdom
        • University Hospital Southampton NHS Foundation Trust
    • Scotland
      • Edinburgh, Scotland, United Kingdom
        • Royal Hospital for Sick Children
    • Wales
      • Cardiff, Wales, United Kingdom
        • Children's Hospital of Wales
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Children's of Alabama
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital Research Institute
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • San Diego, California, United States, 92093
        • The University of California at San Diego
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • The Children's Mercy
    • New York
      • Rochester, New York, United States, 14611
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27708
        • Duke University
    • Ohio
      • Columbus, Ohio, United States, 43205
        • The Research Institute at Nationwide Children's Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Children's Hospital/University of Tennessee
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital/Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • The University of Utah
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALS-008176 Single Dose
Single dose of ALS-008176 administered orally as a suspension
Drug: ALS-008176
Placebo Comparator: Placebo Single Dose
Single dose of placebo administered orally as a suspension
Drug: Placebo
Experimental: ALS-008176 Multiple Doses
Multiple doses of ALS-008176 administered orally as a suspension
Drug: ALS-008176
Placebo Comparator: Placebo Multiple Doses
Multiple doses of placebo administered orally as a suspension
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: Baseline through 6 days post-dose
Baseline through 6 days post-dose
Physical Examinations
Time Frame: Baseline through 6 days post-dose
Baseline through 6 days post-dose
Vital Signs
Time Frame: Baseline through 6 days post-dose
Baseline through 6 days post-dose
12-Lead ECGs
Time Frame: Baseline through 6 days post-dose
Baseline through 6 days post-dose
Clinical Laboratory Results
Time Frame: Baseline through 6 days post-dose
Baseline through 6 days post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RSV viral RNA concentrations in nasal aspirates
Time Frame: Baseline through 6 days post-dose
Baseline through 6 days post-dose
Emergence of resistance
Time Frame: Baseline through 6 days post-dose
Changes in RSV polymerase that result in reduced sensitivity to study drug
Baseline through 6 days post-dose
Pharmacokinetic parameters, including maximum and minimum drug concentrations
Time Frame: Baseline through 6 days post-dose
Baseline through 6 days post-dose
Pharmacokinetic parameters, including time to maximum concentration and half-life
Time Frame: Baseline through 6 days post-dose
Baseline through 6 days post-dose
Pharmacokinetic parameters, including area under concentration-time curves (AUCs)
Time Frame: Baseline through 6 days post-dose
Baseline through 6 days post-dose
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
Baseline through 6 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alios Biopharma Inc.

Investigators

  • Study Director: Matthew McClure, M.D., Alios BioPharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2014

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALS-8176-503
  • 2013-005104-33 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Syncytial Virus Infections

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe