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| Sponsor: | Biota Scientific Management Pty Ltd |
|---|---|
| Information provided by: | Biota Scientific Management Pty Ltd |
| ClinicalTrials.gov Identifier: | NCT00504907 |
Purpose
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 |
|---|---|---|
|
Respiratory Syncytial Virus Infections |
Drug: BTA9881 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | John Lambert, Principal Director Product Development Operations, Biota Scientific Management |
| ClinicalTrials.gov Identifier: | NCT00504907 History of Changes |
| Other Study ID Numbers: | BTA9881-01 |
| Study First Received: | July 18, 2007 |
| Last Updated: | October 11, 2009 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
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RSV |
|
Respiratory Syncytial Virus Infections Virus Diseases Pneumovirus Infections |
Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections |