Respiratory Syncytial Virus (RSV) InfectionPhase 2NCT02718937
Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RSV Viral Challenge Study
A Phase 2 study testing BTA-C585 oral capsule in people with Respiratory Syncytial Virus (RSV) Infection, run by Biota Pharma Europe Limited at 1 site in United Kingdom.
Trial summary
The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585 compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b virus. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV) Infection
- What is being tested?
- BTA-C585 oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Dec 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female
- Between 18 to 50 years old
- Body mass index of 18 to 30 kg/m2
Who cannot join
- Acute or chronic medical illness
- Abnormal lung function Positive for HIV, Hepatitis B or C
- Any significant abnormality of the nose or nasopharynx
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity Against Respiratory Syncytial Virus Infection, and the Pharmacokinetics of Multiple Oral Doses of BTA-C585 in the Virus Challenge Model
The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585 compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b virus.
- Being tested
- BTA-C585 oral capsule, Matching placebo capsules
- Keywords
- Viral diseases, Antiviral, Paramyxoviridae infections, RSV, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
- Medical subject headings
- Infections, Virus Diseases, Paramyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTA-C585 oral capsuleDrug
Also called BTA585
Matching placebo capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| BTA-C585 | Experimental | BTA-C585 100 mg oral capsule Receives: Drug: BTA-C585 oral capsule |
| Placebo | Placebo comparator | Matching placebo capsule Receives: Drug: Matching placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) viral load of RSV-A Memphis 37b
Measured: Days 2-13
Secondary outcomes (2)
Area under the curve (AUC) of total RSV symptom scores
Measured: Days 1-13
Number of adverse events
Measured: Screening to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 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 (RSV) InfectionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biota Pharma Europe Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Novotney-Barry, Study director, Aviragen Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718937
- Sponsor's protocol ID
- BTA585-003
- Status last verified
- May 2018
- First submitted
- 21 Mar 2016
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity Against Respiratory Syncytial Virus Infection, and the Pharmacokinetics of Multiple Oral Doses of BTA-C585 in the Virus Challenge Model
- ClinicalTrials.gov ID
- NCT02718937
- Acronym / sponsor ID
- BTA585-003
- Keywords
- Viral diseases, Antiviral, Paramyxoviridae infections, RSV, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biota Pharma Europe LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Mar 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.
The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585 compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTA-C585 | Experimental | Drug: BTA-C585 oral capsuleBTA-C585 100 mg oral capsule |
| Placebo | Placebo comparator | Drug: Matching placebo capsulesMatching placebo capsule |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female
- Between 18 to 50 years old
- Body mass index of 18 to 30 kg/m2
Key exclusion criteria (3 listed)
- Acute or chronic medical illness
- Abnormal lung function Positive for HIV, Hepatitis B or C
- Any significant abnormality of the nose or nasopharynx
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 |
|---|---|---|
| BTA-C585 oral capsuleAlso: BTA585 | Drug | BTA-C585 |
| Matching placebo capsules | Drug | Placebo |
Primary outcome
Area under the curve (AUC) viral load of RSV-A Memphis 37b
Time frame: Days 2-13
2 secondary outcomes
Area under the curve (AUC) of total RSV symptom scores
Time frame: Days 1-13
Number of adverse events
Time frame: Screening to 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 30 May 2018.
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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.
Anna Novotney-Barry study director
Aviragen Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BTA-C585 oral capsule in people with Respiratory Syncytial Virus (RSV) Infection, run by Biota Pharma Europe Limited at 1 site in United Kingdom.
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 3 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 30 May 2018. 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 United Kingdom. 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?
Area under the curve (AUC) viral load of RSV-A Memphis 37b (time frame: Days 2-13). 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 30 May 2018.