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

2014-08-27 03:17:06 | BioPortfolio

Summary

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).

Description

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).

Based upon a Rapid Diagnostic Test of IFV, subjects will be randomized into one of three groups: a single dose DAS181 10 mg group, a multiple dose DAS181 10 mg, 10 mg, 10 mg dose group or a placebo group.

The full analysis set will include subjects with confirmed influenza as documented with Rapid Diagnostic Testing. The set will be used for activity analysis and will include all randomized subjects with baseline and treatment data. Study staff may visit subjects outside the clinic. Per protocol, the safety analysis sets are described below in Statistical Methods.

Peripheral venous blood samples for pharmacokinetic (PK) and immunogenic analysis of DAS181 will be collected from subpopulation consisting of the first 30 participants enrolled independent of DAS181 or placebo arm and according to the schedule of events.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Influenza

Intervention

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

Location

Hayes Williams MD
Birmingham
Alabama
United States
35216

Status

Recruiting

Source

NexBio, Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:06-0400

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