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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

NCT01037205 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2014-04-08

No results posted yet for this study

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).

Conditions

Interventions

DRUG

DAS181 dry powder, formulation F02

10 mg delivered dose DAS181 in clear HPMC #3 Capsules

DRUG

Respitose ML006 (DMV-Fonterra)

Lactose monohydrate

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Ansun Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Moss, MD · Ansun Biopharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01037205 on ClinicalTrials.gov