Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed Influenza

NCT01037205 Phase 2 COMPLETED

This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).

Details

Lead sponsor	Ansun Biopharma, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	264
Start date	2009-12
Completion	2011-09

Conditions

• Influenza

Interventions

• DAS181 dry powder, formulation F02
• Respitose ML006 (DMV-Fonterra)

Primary outcomes

• Level of influenza viral load as Area Under the Curve at Day 5 (AUC0 d5) as measured by a) quantitative polymerase chain reaction (quantitative PCR) and b) 50% tissue culture infectious dose (TCID50) in cell culture — 28 days
• Safety and toxicity profile: Unacceptable Serious Adverse Events — 28 days

Countries

United States