Respiratory Syncytial Virus InfectionsPhase 1NCT00504907
Safety Study of Oral BTA9881 to Treat RSV Infection
A Phase 1 study testing BTA9881 in people with Respiratory Syncytial Virus Infections, run by Biota Scientific Management Pty Ltd at 1 site in Australia.
Trial summary
This is a placebo-controlled, double-blind, randomised, single dose escalation Phase I clinical trial to determine the safety and tolerability of BTA9881 administered orally to healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- BTA9881
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2007to Dec 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects >=18 and <=45 years of age.
- Individuals who have freely given Informed Consent in writing.
- Male subjects should use appropriate contraception (e.g. condoms) during the time interval between dosing until three months after dosing. Female subjects must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and/or follicle-stimulating hormone (FSH) >18 mIU/mL and serum oestradiol <110 pmol/L), or must agree to use two forms of the following contraception: oral contraceptives, or other forms of hormonal birth control including hormonal vaginal rings or transdermal patches, intra-uterine devices, condoms, and spermicide during the time interval between dosing until three months after dosing. Female subjects must also be non-lactating and have a negative serum pregnancy test at screening and at baseline.
- Able to perform nasal wash procedure.
- Normotensive (systolic BP ≤ 140 mm Hg and diastolic BP ≤ 90 mm Hg).
- No abnormal finding of clinical relevance at the screening examination that the Investigator considers might interfere with the objectives of this clinical trial.
Show all 10Show fewer
- No clinically relevant abnormality in the ECG; QTc <430 ms (males) or <450 ms (females).
- Healthy based on medical history, physical examination, 12-lead ECG and clinical laboratory tests, and with no disease that the Investigator regards as clinically relevant.
- Negative results in Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen (HBsAg) and Hepatitis C antibody tests.
- Willingness to abstain from alcohol and caffeine-containing food and beverages for 48 hours prior to dosing and for the duration of the clinical trial.
Who cannot join
- Use of any prescription medication (other than allowable oral contraceptives and implanted hormonal contraceptives) during the 14 days prior to dosing.
- Use of any non-prescription ('over the counter') product, including herbal products, diet aids, hormone supplements, etc., within 14 days prior to dosing.
- Intake of any investigational drug within 3 months prior to dosing.
- History or clinical evidence of significant cardiovascular disease (including risk factors for cardiac arrhythmias) or a previous history of any cardiovascular condition that, in the opinion of the investigator, would interfere with the conduct of the trial.
- History or clinical evidence of significant cerebrovascular, cardiovascular, gastrointestinal, or haematological disease, or myocardial infarction, or a previous history of any other serious underlying disease (including immunocompromised subjects and/or neutropenic subjects) that, in the opinion of the investigator would interfere with the conduct of the clinical trial.
- History or clinical evidence of significant respiratory disease (including asthma, chronic obstructive pulmonary disease, cystic fibrosis and/or recurrent lower respiratory tract infection), or upper respiratory tract infection within the last month or lower respiratory tract infection within the last three months.
Show all 17Show fewer
- History or clinical evidence of renal disease (including renovascular occlusive disease), nephrectomy and/or renal transplant, and/or previous clinically significant laboratory abnormalities of renal function parameters. All subjects with serum creatinine or proteinuria outside the normal laboratory reference range at screening and baseline that are regarded by the Investigator as clinically significant.
- History or clinical evidence of hepatic disease and/or previous clinically significant laboratory abnormalities of liver function parameters. All subjects with bilirubin, gamma glutamyl transferase (GGT), alanine transaminase (ALT), and aspartate transaminase (AST) outside the normal laboratory reference range at screening and baseline, that are regarded by the Investigator as clinically significant. Subjects known to have experienced elevated liver enzyme values in previous clinical studies will also be excluded.
- History or clinical evidence of adrenal disease (including Cushing's Syndrome or Addison's disease) or thyroid disease (including hyper or hypothyroidism), and/or previous clinically significant laboratory abnormalities of adrenal or thyroid function parameters. All subjects with thyroid function (TSH, FT4, FT3) outside the normal laboratory reference range at baseline and regarded by the Investigator as clinically significant.
- Psychiatric or emotional problems that would invalidate the giving of Informed Consent or limit the ability of the subject to comply with clinical trial requirements.
- Body Mass Index (BMI) ≤18.5 kg/m2 or >=30.0 kg/m2.
- History of alcohol and/or drug abuse within 1 year prior to screening (verified by drug screening).
- Receipt of blood or blood products, or loss of 450 mL or more of blood, during the last three months prior to dosing.
- Unwillingness or inability to provide Informed Consent or to participate satisfactorily for the entire clinical trial period.
- Subjects who smoke or have been non-smokers for less than 3 months prior to dosing.
- Subjects who were previously enrolled in this clinical trial.
- Poor veins, or fear of venipuncture or sight of blood, or known allergy or hypersensitivity to lidocaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Centre, Double-Blind, Placebo-Controlled, Escalating Single Oral Dose, Safety and Tolerability Clinical Trial With BTA9881 in Healthy Subjects
This is a placebo-controlled, double-blind, randomised, single dose escalation Phase I clinical trial to determine the safety and tolerability of BTA9881 administered orally to healthy subjects
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- BTA9881, 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.
BTA9881Drug
Single oral escalating doses
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Placebo or BTA9881 -10mg Receives: Drug: BTA9881; Drug: Placebo |
| Cohort B | Experimental | Placebo or BTA9881 - 10mg Receives: Drug: BTA9881; Drug: Placebo |
| Cohort C | Experimental | Placebo or BTA9881 - 25mg Receives: Drug: BTA9881; Drug: Placebo |
| Cohort D | Experimental | Placebo or BTA9881 - 50mg Receives: Drug: BTA9881; Drug: Placebo |
| Cohort E | Experimental | Placebo or BTA9881 - 100mg Receives: Drug: BTA9881; Drug: Placebo |
| Cohort F | Experimental | Placebo or BTA9881 - 200mg Receives: Drug: BTA9881; Drug: Placebo |
| Cohort G | Experimental | Placebo or BTA9881 - 400mg Receives: Drug: BTA9881; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of ascending single oral doses of BTA9881 in healthy adult subjects.
Measured: Two weeks
Secondary outcomes (1)
To assess the pharmacokinetics and dose proportionality of BTA9881 after a single oral dose in healthy adult subjects
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionDec 2008
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biota Scientific Management Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Hodsman, MD, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504907
- Sponsor's protocol ID
- BTA9881-01
- Status last verified
- May 2018
- First submitted
- 18 Jul 2007
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 Phase I, Single-Centre, Double-Blind, Placebo-Controlled, Escalating Single Oral Dose, Safety and Tolerability Clinical Trial With BTA9881 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00504907
- Acronym / sponsor ID
- BTA9881-01
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Biota Scientific Management Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Jul 2007 (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 is a placebo-controlled, double-blind, randomised, single dose escalation Phase I clinical trial to determine the safety and tolerability of BTA9881 administered orally to healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: BTA9881, Drug: PlaceboPlacebo or BTA9881 -10mg |
| Cohort B | Experimental | Drug: BTA9881, Drug: PlaceboPlacebo or BTA9881 - 10mg |
| Cohort C | Experimental | Drug: BTA9881, Drug: PlaceboPlacebo or BTA9881 - 25mg |
| Cohort D | Experimental | Drug: BTA9881, Drug: PlaceboPlacebo or BTA9881 - 50mg |
| Cohort E | Experimental | Drug: BTA9881, Drug: PlaceboPlacebo or BTA9881 - 100mg |
| Cohort F | Experimental | Drug: BTA9881, Drug: PlaceboPlacebo or BTA9881 - 200mg |
| Cohort G | Experimental | Drug: BTA9881, Drug: PlaceboPlacebo or BTA9881 - 400mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male and female subjects >=18 and <=45 years of age.
- Individuals who have freely given Informed Consent in writing.
- Male subjects should use appropriate contraception (e.g. condoms) during the time interval between dosing until three months after dosing. Female subjects must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and/or follicle-stimulating hormone (FSH) >18 mIU/mL and serum oestradiol <110 pmol/L), or must agree to use two forms of the following contraception: oral contraceptives, or other forms of hormonal birth control including hormonal vaginal rings or transdermal patches, intra-uterine devices, condoms, and spermicide during the time interval between dosing until three months after dosing. Female subjects must also be non-lactating and have a negative serum pregnancy test at screening and at baseline.
- Able to perform nasal wash procedure.
- Normotensive (systolic BP ≤ 140 mm Hg and diastolic BP ≤ 90 mm Hg).
Key exclusion criteria (17 listed)
- Use of any prescription medication (other than allowable oral contraceptives and implanted hormonal contraceptives) during the 14 days prior to dosing.
- Use of any non-prescription ('over the counter') product, including herbal products, diet aids, hormone supplements, etc., within 14 days prior to dosing.
- Intake of any investigational drug within 3 months prior to dosing.
- History or clinical evidence of significant cardiovascular disease (including risk factors for cardiac arrhythmias) or a previous history of any cardiovascular condition that, in the opinion of the investigator, would interfere with the conduct of the trial.
- History or clinical evidence of significant cerebrovascular, cardiovascular, gastrointestinal, or haematological disease, or myocardial infarction, or a previous history of any other serious underlying disease (including immunocompromised subjects and/or neutropenic subjects) that, in the opinion of the investigator would interfere with the conduct of the clinical trial.
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 |
|---|---|---|
| BTA9881Single oral escalating doses | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E, Cohort F, Cohort G |
| Placebo | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E, Cohort F, Cohort G |
Primary outcome
To evaluate the safety and tolerability of ascending single oral doses of BTA9881 in healthy adult subjects.
Time frame: Two weeks
1 secondary outcome
To assess the pharmacokinetics and dose proportionality of BTA9881 after a single oral dose in healthy adult subjects
Time frame: Two weeks
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.
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.
Peter Hodsman, MD principal investigator
Nucleus Network
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 BTA9881 in people with Respiratory Syncytial Virus Infections, run by Biota Scientific Management Pty Ltd at 1 site in Australia.
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 10 inclusion and 17 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 Australia. 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. 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?
To evaluate the safety and tolerability of ascending single oral doses of BTA9881 in healthy adult subjects. (time frame: Two weeks). 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.