Respiratory Syncytial Virus InfectionsPhase 2NCT02673476
A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus
A Phase 2 study testing ALS-008176 in people with Respiratory Syncytial Virus Infections, run by Alios Biopharma Inc. at 21 sites in 5 countries.
Trial summary
This study is being to see how effective and safe ALS-008176 is in treating adults in the hospital with a Respiratory Syncytial Virus-Related Illness. Read more about this study
- Who is it for?
- Ages 50 years and older
- 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
- 9 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 29 Feb 2016to 31 Oct 2016
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥50 years of age.
- 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.
- 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.
- 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.
- 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.
- 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.
Who cannot join
- Subject is undergoing peritoneal dialysis, hemodialysis or hemofiltration or has an estimated glomerular filtration rate (GFR, determined by Cockcroft-Gault Formula) <30 mL/min.
- 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.
- 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.
- Subject has a known history of human immunodeficiency virus (HIV) or chronic, active hepatitis infection.
- ALT >3×ULN AND bilirubin >2×ULN (direct >35%) OR ALT>5×ULN
- Subjects who have been hospitalized for >72 hours at the time of randomization.
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- Subjects anticipated to be hospitalized for <24 hours after randomization.
- Subjects who are not expected to survive for <48 hours.
- 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.
- 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.
- Subjects unwilling to undergo regular nasal swab procedures or with any physical abnormality which limits the ability to collect regular nasal specimens.
- Subjects that are considered by the investigator to be immunocompromised over the past 12 months, whether due to underlying medical condition or medical therapy.
- 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.
- Female subject that is pregnant or breastfeeding
- 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.
- 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).
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United States11 sites
Infectious Disease Specialists of Atlanta
Atlanta, Georgia, 30033
University of Missouri- Clinical Research Center
Columbia, Missouri, 65212
Lake Internal Med. Assoc.
Eustis, Florida, 32726
Kentucky Lung Clinic, PSC
Hazard, Kentucky, 41701
The Research Center, Inc.
Hialeah, Florida, 33013
Bronson Methodist Hosp. Ped
Kalamazoo, Michigan, 49007
JDH Medical Group LLC
Miami, Florida, 33186
St Lucie Medical Center
Port Saint Lucie, Florida, 34952
Washington Univ School of Med
St Louis, Missouri, 63110
Tampa Genereal Hospital
Tampa, Florida, 33606
William Beaumont Hospital
Troy, Michigan, 48085
Australia7 sites
Cairns Hospital
Cairns, Queensland, 4870
Monash Heal.-Monash Lung&Sleep
Clayton, Victoria, 3168
Westmead Hospital
Northmead, New South Wales, 2145
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Mater Adult Hospital
South Brisbane, Queensland, 4101
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand1 site
Wellington Regional Hospital
Newtown, Wellington Region, 6021
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus-Related Illness
This study is being to see how effective and safe ALS-008176 is in treating adults in the hospital with a Respiratory Syncytial Virus-Related Illness.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- ALS-008176, Placebo
- 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
ALS-008176 tablets
PlaceboDrug
Identical placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Identical Placebo Comparator Receives: Drug: Placebo |
| ALS-008176 | Experimental | ALS-008176 tablets Receives: Drug: ALS-008176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of RSV RNA
Area under the curve (AUC) of RSV ribonucleic acid (RNA) from nasal swabs immediately prior to 1st dose of study drug (baseline) until Day 7.
Measured: From prior to first dose to study day 7
Secondary outcomes (11)
Time from baseline to non-detectability of RSV from nasal swab
Time from baseline to non-detectability of RSV from nasal swab
Measured: From prior first dose to study day 28
Percent of subjects with undetectable RSV by qPCR
Percent of subjects with undetectable RSV by qPCR on Day 3, Day 5, and every other day until 2 days after last dose from nasal swab
Measured: From study day 3, and every two days until study day 7
Peak post-baseline viral load
Peak post-baseline viral load from nasal swab
Measured: From before first dose to study day 28
Rate of decline from baseline in viral load during treatment from nasal swab
Rate of decline from baseline in viral load during treatment from nasal swab
Measured: From before first dose to study day 2
Duration of hospital stay
Duration of hospital stay
Measured: From first dose to study day 28
Safety data: Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results
Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine).
Measured: From screening to study day 28
PK parameters: Cmax
PK parameters in plasma following repeat dose administration: Cmax
Measured: From first dose to study day 28
PK parameters: tmax
PK parameters in plasma following repeat dose administration: tmax
Measured: From first dose to study day 28
PK parameters: AUClast
PK parameters in plasma following repeat dose administration: AUClast
Measured: From first dose to study day 28
PK parameters: t1/2
PK parameters in plasma following repeat dose administration: t1/2
Measured: From first dose to study day 28
PK parameters: AUC0 tau
PK parameters in plasma following repeat dose administration: AUC0 tau
Measured: From first dose to study day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start29 Feb 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alios Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abbie Oey, Study director, Alios Biopharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673476
- Sponsor's protocol ID
- ALS-8176-510
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2016
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus-Related Illness
- ClinicalTrials.gov ID
- NCT02673476
- Acronym / sponsor ID
- ALS-8176-510
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Alios Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 4 Feb 2016 (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 is being to see how effective and safe ALS-008176 is in treating adults in the hospital with a Respiratory Syncytial Virus-Related Illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIdentical Placebo Comparator |
| ALS-008176 | Experimental | Drug: ALS-008176ALS-008176 tablets |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is ≥50 years of age.
- 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.
- 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.
- 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.
- 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.
Key exclusion criteria (16 listed)
- Subject is undergoing peritoneal dialysis, hemodialysis or hemofiltration or has an estimated glomerular filtration rate (GFR, determined by Cockcroft-Gault Formula) <30 mL/min.
- 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.
- 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.
- Subject has a known history of human immunodeficiency virus (HIV) or chronic, active hepatitis infection.
- ALT >3×ULN AND bilirubin >2×ULN (direct >35%) OR ALT>5×ULN
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-008176ALS-008176 tablets | Drug | ALS-008176 |
| PlaceboIdentical placebo tablets | Drug | Placebo |
Primary outcome
AUC of RSV RNA
Time frame: From prior to first dose to study day 7
Area under the curve (AUC) of RSV ribonucleic acid (RNA) from nasal swabs immediately prior to 1st dose of study drug (baseline) until Day 7.
11 secondary outcomes
Time from baseline to non-detectability of RSV from nasal swab
Time frame: From prior first dose to study day 28
Percent of subjects with undetectable RSV by qPCR
Time frame: From study day 3, and every two days until study day 7
Peak post-baseline viral load
Time frame: From before first dose to study day 28
Rate of decline from baseline in viral load during treatment from nasal swab
Time frame: From before first dose to study day 2
Duration of hospital stay
Time frame: From first dose to study day 28
Safety data: Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results
Time frame: From screening to study day 28
PK parameters: Cmax
Time frame: From first dose to study day 28
PK parameters: tmax
Time frame: From first dose to study day 28
PK parameters: AUClast
Time frame: From first dose to study day 28
PK parameters: t1/2
Time frame: From first dose to study day 28
PK parameters: AUC0 tau
Time frame: From first dose to study day 28
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 4 Feb 2025.
- Individual participant dataSharing planned: No. No data will be shared
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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.
Abbie Oey study director
Alios Biopharma Inc.
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALS-008176 in people with Respiratory Syncytial Virus Infections, run by Alios Biopharma Inc. at 21 sites in 5 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 6 inclusion and 16 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 4 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 21 sites in United States, Australia, New Zealand, Singapore, Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
AUC of RSV RNA (time frame: From prior to first dose to study day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025.