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Sponsors and Collaborators: |
Biota Scientific Management Pty Ltd MedImmune LLC |
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Information provided by: | Biota Scientific Management Pty Ltd |
ClinicalTrials.gov Identifier: | NCT00504907 |
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
Condition | Intervention | Phase |
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Respiratory Syncytial Virus Infections |
Drug: BTA9881 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety 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 |
Estimated Enrollment: | 81 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | May 2008 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Contact: Anne E Altmann, MD | +61 3 9915 3700 ext 3741 | a.altmann@biota.com.au |
Australia, Victoria | |
Nucleus Network | Recruiting |
Melbourne, Victoria, Australia, 3004 |
Principal Investigator: | Peter Hodsman, MD | Nucleus Network |
Study ID Numbers: | BTA9881-01 |
Study First Received: | July 18, 2007 |
Last Updated: | November 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00504907 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
RSV |
Virus Diseases Paramyxoviridae Infections Healthy Respiratory Syncytial Virus Infections |
Virus Diseases Communicable Diseases RNA Virus Infections Pneumovirus Infections |
Paramyxoviridae Infections Respiratory Syncytial Virus Infections Infection Mononegavirales Infections |