Respiratory Syncytial Virus InfectionsPhase 1NCT01906164
Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers
A Phase 1 study testing ALS-008176 in people with Respiratory Syncytial Virus Infections, run by Alios Biopharma Inc. at 1 site in France.
Trial summary
This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- ALS-008176
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2013to 30 Nov 2013
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects, 18-55 years of age, in good health with screening laboratory values within limits specified by the protocol
- Body mass index 18-30 kg/m2
- Female subjects must be of non-childbearing potential; male subjects must be surgically sterile or practicing birth control
Who cannot join
- Clinically significant or uncontrolled medical illness
- Use, or anticipated use during conduct of the study, of concomitant medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing, Multiple Ascending Dosing and Food-effect in Healthy Volunteers
This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- ALS-008176, Placebo
- Keywords
- RSV
- 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 | Experimental | Not described Receives: Drug: ALS-008176 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety data including, but not limited to, tabulation of adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urine)
Measured: 11 days
Secondary outcomes (4)
PK parameters of ALS-008176 and metabolites in plasma following single dose administration: Cmax, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h, AUC0-inf or AUC0-last
Measured: 11 days
PK parameters of ALS-008176 and metabolites in plasma following repeat dose administration: Cmax, Cmin, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h , AUC0-last and AUC0 tau
Measured: 11 days
Urinary excretion and concentrations of ALS-008176 and metabolites after a single oral dose and multiple doses in healthy volunteers in fasted conditions
Measured: 11 days
PK parameters of ALS-008176 and metabolites in plasma after a single oral dose in healthy volunteers in fasted conditions as compared with fed conditions: Cmax, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h, AUC0-inf or AUC0-last
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study start31 May 2013
- Primary completion30 Nov 2013
- Study completion30 Nov 2013
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 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
- NCT01906164
- Sponsor's protocol ID
- ALS-8176-501
- Other IDs
- 2012-004894-14
- Status last verified
- Oct 2017
- First submitted
- 3 Jul 2013
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing, Multiple Ascending Dosing and Food-effect in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01906164
- Acronym / sponsor ID
- ALS-8176-501
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Alios Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2013 (actual)
- Primary completion
- 30 Nov 2013 (actual)
- Study completion
- 30 Nov 2013 (actual)
- First posted
- 24 Jul 2013 (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, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS-008176 | Experimental | Drug: ALS-008176 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female subjects, 18-55 years of age, in good health with screening laboratory values within limits specified by the protocol
- Body mass index 18-30 kg/m2
- Female subjects must be of non-childbearing potential; male subjects must be surgically sterile or practicing birth control
Key exclusion criteria (2 listed)
- Clinically significant or uncontrolled medical illness
- Use, or anticipated use during conduct of the study, of concomitant medications
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 |
| Placebo | Drug | Placebo |
Primary outcome
Safety data including, but not limited to, tabulation of adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urine)
Time frame: 11 days
4 secondary outcomes
PK parameters of ALS-008176 and metabolites in plasma following single dose administration: Cmax, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h, AUC0-inf or AUC0-last
Time frame: 11 days
PK parameters of ALS-008176 and metabolites in plasma following repeat dose administration: Cmax, Cmin, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h , AUC0-last and AUC0 tau
Time frame: 11 days
Urinary excretion and concentrations of ALS-008176 and metabolites after a single oral dose and multiple doses in healthy volunteers in fasted conditions
Time frame: 11 days
PK parameters of ALS-008176 and metabolites in plasma after a single oral dose in healthy volunteers in fasted conditions as compared with fed conditions: Cmax, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h, AUC0-inf or AUC0-last
Time frame: 11 days
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 31 Oct 2017.
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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.
Matthew McClure, M.D. study director
Alios BioPharma
1 site in 1 country: 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 1 site in France.
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 3 inclusion and 2 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 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Safety data including, but not limited to, tabulation of adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urine) (time frame: 11 days). 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 31 Oct 2017.