Respiratory Syncytial Virus InfectionsPhase 1NCT02202356
A Study of ALS-008176 in Infants Hospitalized With RSV
A Phase 1 study testing ALS-008176 in people with Respiratory Syncytial Virus Infections, run by Alios Biopharma Inc. at 77 sites in 14 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- ALS-008176
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 77 sitesin 14 countries
- Study dates
- 23 Jul 2014to 15 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
77 sites in 14 countries.
77 sites in 14 countries
United States17 sites
Children's of Alabama
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27708
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030
The Children's Mercy
Kansas City, Missouri, 64108
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach
Long Beach, California, 90806
Children's Hospital/University of Tennessee
Memphis, Tennessee, 38103
Children's Hospital of Orange County
Orange, California, 92868
University of Rochester
Rochester, New York, 14611
The University of Utah
Salt Lake City, Utah, 84112
The University of California at San Diego
San Diego, California, 92093
Seattle Children's Hospital
Seattle, Washington, 98105
LSU Health Sciences Center
Shreveport, Louisiana, 71103
Japan17 sites
Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital
Asahikawa-shi, Hokkaido
Chiba Children's Hospital
Chiba, Chiba
Tokyo Metropolitan Children's Medical Center
Fuchu-shi, Tokyo
Fukuoka Children's Hospital
Fukuoka
NHO Fukuoka Hospital
Fukuoka
NHO Fukuyama Medical Center
Fukuyama, Hiroshima
Hirosaki National Hospital
Hirosaki-shi, Aomori
NHO Kanazawa Medical Center
Kanazawa, Ishikawa-ken
Kochi Health Sciences Center
Kochi, 781-8555
Nakano Children's Hospital
Osaka, Osaka
Ota Memorial Hospital
Ōta, Gunma, 373-8585
Saitama Children's Medical Center
Saitama
National Center for Child Health and Development
Setagaya-ku, Tokyo
Gunma Children's Medical Center
Shibukawa-shi, Gunma
NHO Shikoku Medical Center for Children and Adults
Takamatsu, Kagawa-ken
Okinawa Chubu Hospital
Urumi, Okinawa
National Hospital Organization Saitama National Hospital
Wako, Saitama, 351-0102
United Kingdom11 sites
Birmingham Children's Hospital
Birmingham
Royal Alexandra Children's Hospital
Brighton
Bristol Royal Hospital for Children
Bristol, England
Children's Hospital of Wales
Cardiff, Wales
Royal Hospital for Sick Children
Edinburgh, Scotland
Alder Hey Children's Hospital
Liverpool, England
St. George's University of London
London, England
Royal Manchester Children's Hospital
Manchester
Queens Medical Center
Nottingham
University of Oxford
Oxford
University Hospital Southampton NHS Foundation Trust
Southampton, England
Australia5 sites
The Canberra Hospital
Canberra
Monash Medical Center
Melbourne
Women's and Children's Hospital
North Adelaide
The Royal Children's Hospital Melbourne
Parkville
Princess Margaret Hospital
Perth
Canada4 sites
Canadian Centre for Vaccinology IWK Health Centre
Halifax, Nova Scotia
McMaster Children's Hospital
Hamilton, Ontario
McGill University Health Centre
Montreal, Quebec
The Children's Hospital Research Institute of Manitoba
Winnipeg, Manitoba
Thailand4 sites
Chulalongkorn University Department of Pediatrics
Bangkok
Phramongkutklao Hospital Department of Pediatrics
Bangkok
Siriraj Hospital, Mahidol University Department of Pediatrics
Bangkok
Khon Kaen University Department of Pediatrics
Khon Kaen
Chile3 sites
Hospital Dr. Exequiel Gonzalez Cortes
San Miguel, Santiago Metropolitan
Complejo Asistencial Dr Sotero del Rio
Santiago
Hospital Padre Hurtado
Santiago
New Zealand3 sites
Christchurch Clinical Study Trust
Christchurch
Hawke's Bay Hospital
Hastings
Wellington Hospital
Wellington
Panama3 sites
Hospital Materno Infantil Jose Dominog de Obaldila
David, Chiriquí Province
Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"
Panama City
Hospital del Nino
Panama City
South Africa3 sites
2 Military Hospital
Cape Town
Kingsbury Hospital
Cape Town
Tygerberg Academic Hospital
Cape Town
Colombia2 sites
Fundacion Cardio Infantil Instituto de Cardiologia
Bogotá
Hospital Pablo Tobon Uribe
Medellín
France2 sites
CHU Pellegrin / Pneumologie pediatrique
Bordeaux
Hopital Necker
Paris
Taiwan2 sites
Linkou Chang Gung Medical Hospital
Taipei
MacKay Memorial Hospital
Taipei
About this study
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
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)
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- ALS-008176, Placebo
- Keywords
- RSV, Respiratory Syncytial Virus
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALS-008176Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ALS-008176 Single Dose | Experimental | Single dose of ALS-008176 administered orally as a suspension Receives: Drug: ALS-008176 |
| Placebo Single Dose | Placebo comparator | Single dose of placebo administered orally as a suspension Receives: Drug: Placebo |
| ALS-008176 Multiple Doses | Experimental | Multiple doses of ALS-008176 administered orally as a suspension Receives: Drug: ALS-008176 |
| Placebo Multiple Doses | Placebo comparator | Multiple doses of placebo administered orally as a suspension Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Baseline through 6 days post-dose
Physical Examinations
Measured: Baseline through 6 days post-dose
Vital Signs
Measured: Baseline through 6 days post-dose
12-Lead ECGs
Measured: Baseline through 6 days post-dose
Clinical Laboratory Results
Measured: Baseline through 6 days post-dose
Secondary outcomes (6)
RSV viral RNA concentrations in nasal aspirates
Measured: Baseline through 6 days post-dose
Emergence of resistance
Changes in RSV polymerase that result in reduced sensitivity to study drug
Measured: Baseline through 6 days post-dose
Pharmacokinetic parameters, including maximum and minimum drug concentrations
Measured: Baseline through 6 days post-dose
Pharmacokinetic parameters, including time to maximum concentration and half-life
Measured: Baseline through 6 days post-dose
Pharmacokinetic parameters, including area under concentration-time curves (AUCs)
Measured: Baseline through 6 days post-dose
Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)
Measured: Baseline through 6 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study start23 Jul 2014
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alios Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew McClure, M.D., Study director, Alios BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202356
- Sponsor's protocol ID
- ALS-8176-503
- Other IDs
- 2013-005104-33
- Status last verified
- Jan 2025
- First submitted
- 23 Jul 2014
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
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.
PubMed 37467213
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02202356
- Acronym / sponsor ID
- ALS-8176-503
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV, Respiratory Syncytial Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Alios Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2014 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALS-008176 Single Dose | Experimental | Drug: ALS-008176Single dose of ALS-008176 administered orally as a suspension |
| Placebo Single Dose | Placebo comparator | Drug: PlaceboSingle dose of placebo administered orally as a suspension |
| ALS-008176 Multiple Doses | Experimental | Drug: ALS-008176Multiple doses of ALS-008176 administered orally as a suspension |
| Placebo Multiple Doses | Placebo comparator | Drug: PlaceboMultiple doses of placebo administered orally as a suspension |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALS-008176 | Drug | ALS-008176 Multiple Doses, ALS-008176 Single Dose |
| Placebo | Drug | Placebo Multiple Doses, Placebo Single Dose |
Primary outcome
Adverse Events
Time frame: Baseline through 6 days post-dose
Physical Examinations
Time frame: Baseline through 6 days post-dose
Vital Signs
Time frame: Baseline through 6 days post-dose
12-Lead ECGs
Time frame: Baseline through 6 days post-dose
Clinical Laboratory Results
Time frame: Baseline through 6 days post-dose
6 secondary outcomes
RSV viral RNA concentrations in nasal aspirates
Time frame: Baseline through 6 days post-dose
Emergence of resistance
Time frame: Baseline through 6 days post-dose
Pharmacokinetic parameters, including maximum and minimum drug concentrations
Time frame: Baseline through 6 days post-dose
Pharmacokinetic parameters, including time to maximum concentration and half-life
Time frame: Baseline through 6 days post-dose
Pharmacokinetic parameters, including area under concentration-time curves (AUCs)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 37467213Oey 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.
Related trials for Respiratory Syncytial Virus Infections
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew McClure, M.D. study director
Alios BioPharma
77 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALS-008176 in people with Respiratory Syncytial Virus Infections, run by Alios Biopharma Inc. at 77 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Japan, United Kingdom, Australia, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Baseline through 6 days post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.