Clinical Trial: Safety Study of Oral BTA9881 to Treat RSV Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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

Detailed Summary:
Sponsor: Biota Scientific Management Pty Ltd

Current Primary Outcome: To evaluate the safety and tolerability of ascending single oral doses of BTA9881 in healthy adult subjects. [ Time Frame: Two weeks ]

Original Primary Outcome: To evaluate the safety and tolerability of ascending single oral doses of BTA9881 in healthy adult subjects. [ Time Frame: One week ]

Current Secondary Outcome: To assess the pharmacokinetics and dose proportionality of BTA9881 after a single oral dose in healthy adult subjects [ Time Frame: Two weeks ]

Original Secondary Outcome: To assess the pharmacokinetics and dose proportionality of BTA9881 after a single oral dose in healthy adult subjects [ Time Frame: One week ]

Information By: Aviragen Therapeutics

Dates:
Date Received: July 18, 2007
Date Started: July 2007
Date Completion:
Last Updated: March 31, 2015
Last Verified: March 2015