A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus
NCT ID: NCT02673476
Last Updated: 2025-02-04
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
PHASE2
9 participants
INTERVENTIONAL
2016-02-29
2016-10-31
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.
A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model
NCT02094365
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Participants
NCT02478333
Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.
NCT02387606
A Study of AL-794 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses, and the Antiviral Activity of Multiple Doses in an Influenza Challenge Study
NCT02588521
A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza
NCT00705406
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
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Identical Placebo Comparator
Placebo
Identical placebo tablets
ALS-008176
ALS-008176 tablets
ALS-008176
ALS-008176 tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ALS-008176
ALS-008176 tablets
Placebo
Identical placebo tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Female subjects of non-childbearing potential (i.e., surgically sterilized, post-menopausal \[amenorrhea for 1 year confirmed by negative hormone panel\]) who also have a negative pregnancy test at screening.
3. Male subjects must be either surgically sterilized (e.g., post-vasectomy or orchiectomy) or willing to adhere to the study's contraceptive requirements. Male subjects'female partner(s) must be surgically sterilized or post-menopausal (amenorrhea for 1 year) or their female partner(s) of child-bearing potential must be willing and able to adhere to the contraceptive requirements.
4. Each subject or their legal guardian must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study before starting any screening activities.
5. Subject has a positive RT-PCR test result for RSV at the time of screening. NOTE: Co-infection with other acute viruses or bacteria is permitted.
6. Subject has been, or will be, admitted to the hospital for an acute respiratory illness with signs and symptoms consistent with a viral infection (e.g., fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset \<7 days from the anticipated time of randomization.
Exclusion Criteria
2. Subject has presence of any concurrent illness, including laboratory, vital sign, ECG, or physical exam findings, or medical history that, in the opinion of the investigator, would place the subject at an unreasonably increased risk as a result of participation in this study.
3. Subject reports receiving an investigational drug or vaccine within 30 days, or 5 half-lives (whichever is longer) prior to the planned first dose of study drug.
4. Subject has a known history of human immunodeficiency virus (HIV) or chronic, active hepatitis infection.
5. ALT \>3×ULN AND bilirubin \>2×ULN (direct \>35%) OR ALT\>5×ULN
6. Subjects who have been hospitalized for \>72 hours at the time of randomization.
7. Subjects anticipated to be hospitalized for \<24 hours after randomization.
8. Subjects who are not expected to survive for \<48 hours.
9. Recent (\<5 half-lives) use, or anticipated use during conduct of the study, of concomitant medications (prescription and non-prescription) which are inhibitors of the OAT3 transporter.
10. Treatment of the current illness with drugs specifically targeting the RSV infection itself (e.g., RSV immunoglobulin, ribavirin, palivizumab). Medications treating the sequelae of the RSV infection or any concurrent illness are permitted if not otherwise excluded.
11. Subjects unwilling to undergo regular nasal swab procedures or with any physical abnormality which limits the ability to collect regular nasal specimens.
12. Subjects that are considered by the investigator to be immunocompromised over the past 12 months, whether due to underlying medical condition or medical therapy.
13. Subjects unable to take medications enterally (e.g., orally or via nasogastric or PEG tube) or a known gastrointestinal-related condition that may interfere with study drug absorption.
14. Female subject that is pregnant or breastfeeding
15. In the investigator's opinion, the subject is unwilling or unable to comply with protocol requirements, instructions, and protocol stated restrictions, and is unlikely to complete the study as planned.
16. Subject has known or suspected hypersensitivity to the study drug or its excipients (microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide).
50 Years
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.
Abbie Oey
Role: STUDY_DIRECTOR
Alios Biopharma Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lake Internal Med. Assoc.
Eustis, Florida, United States
The Research Center, Inc.
Hialeah, Florida, United States
JDH Medical Group LLC
Miami, Florida, United States
St Lucie Medical Center
Port Saint Lucie, Florida, United States
Tampa Genereal Hospital
Tampa, Florida, United States
Infectious Disease Specialists of Atlanta
Atlanta, Georgia, United States
Kentucky Lung Clinic, PSC
Hazard, Kentucky, United States
Bronson Methodist Hosp. Ped
Kalamazoo, Michigan, United States
William Beaumont Hospital
Troy, Michigan, United States
University of Missouri- Clinical Research Center
Columbia, Missouri, United States
Washington Univ School of Med
St Louis, Missouri, United States
Westmead Hospital
Northmead, New South Wales, Australia
Cairns Hospital
Cairns, Queensland, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Monash Heal.-Monash Lung&Sleep
Clayton, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Wellington Regional Hospital
Newtown, Wellington Region, New Zealand
Raffles Hospital
Singapore, , Singapore
Taipei Med. Uni-Shuang Ho Hosp
New Taipei City, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ALS-8176-510
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.