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Trial details imported from ClinicalTrials.gov
Ethics application status
Safety Study of Oral BTA9881 to Treat RSV Infection
A Phase I, Single-Centre, Double-Blind, Placebo-Controlled, Escalating Single Oral Dose, Safety and Tolerability Clinical Trial With BTA9881 in Healthy Subjects
Universal Trial Number (UTN)
Respiratory Syncytial Virus Infections
Other respiratory disorders / diseases
Other infectious diseases
Studies of infection and infectious agents
Description of intervention(s) / exposure
Treatment: Drugs - BTA9881
Treatment: Drugs - Placebo
Experimental: Cohort A - Placebo or BTA9881 -10mg
Experimental: Cohort B - Placebo or BTA9881 - 10mg
Experimental: Cohort C - Placebo or BTA9881 - 25mg
Experimental: Cohort D - Placebo or BTA9881 - 50mg
Experimental: Cohort E - Placebo or BTA9881 - 100mg
Experimental: Cohort F - Placebo or BTA9881 - 200mg
Experimental: Cohort G - Placebo or BTA9881 - 400mg
Treatment: Drugs: BTA9881
Single oral escalating doses
Treatment: Drugs: Placebo
Intervention code 
Comparator / control treatment
Primary outcome 
To evaluate the safety and tolerability of ascending single oral doses of BTA9881 in healthy adult subjects.
Secondary outcome 
To assess the pharmacokinetics and dose proportionality of BTA9881 after a single oral dose in healthy adult subjects
Key inclusion criteria
1. Healthy male and female subjects >=18 and <=45 years of age.
2. Individuals who have freely given Informed Consent in writing.
3. 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
4. Able to perform nasal wash procedure.
5. Normotensive (systolic BP = 140 mm Hg and diastolic BP = 90 mm Hg).
6. No abnormal finding of clinical relevance at the screening examination that the
Investigator considers might interfere with the objectives of this clinical trial.
7. No clinically relevant abnormality in the ECG; QTc <430 ms (males) or <450 ms
8. Healthy based on medical history, physical examination, 12-lead ECG and clinical
laboratory tests, and with no disease that the Investigator regards as clinically
9. Negative results in Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface
antigen (HBsAg) and Hepatitis C antibody tests.
10. 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.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Use of any prescription medication (other than allowable oral contraceptives and
implanted hormonal contraceptives) during the 14 days prior to dosing.
2. Use of any non-prescription ('over the counter') product, including herbal products,
diet aids, hormone supplements, etc., within 14 days prior to dosing.
3. Intake of any investigational drug within 3 months prior to dosing.
4. 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
5. 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.
6. 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.
7. 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.
8. 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.
9. 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
10. 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.
11. Body Mass Index (BMI) =18.5 kg/m2 or >=30.0 kg/m2.
12. History of alcohol and/or drug abuse within 1 year prior to screening (verified by
13. Receipt of blood or blood products, or loss of 450 mL or more of blood, during the
last three months prior to dosing.
14. Unwillingness or inability to provide Informed Consent or to participate
satisfactorily for the entire clinical trial period.
15. Subjects who smoke or have been non-smokers for less than 3 months prior to dosing.
16. Subjects who were previously enrolled in this clinical trial.
17. Poor veins, or fear of venipuncture or sight of blood, or known allergy or
hypersensitivity to lidocaine.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Nucleus Network - Melbourne
Recruitment postcode(s) 
Primary sponsor type
Biota Scientific Management Pty Ltd
Ethics application status
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
Trial related presentations / publications