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Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza

NCT01740063 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2019-07-08

No results posted yet for this study

Summary

This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza virus (IFV).

Subjects will be randomized into one of three treatment groups: a DAS181 30 mg total dose group (DAS181-F02 formulation), a DAS181 60 mg total dose group (DAS181-F04 formulation) or a placebo group.

The modified intent to treat (mITT) analysis set will include subjects with confirmed influenza as documented by qPCR or TCID50. The full analysis set will be used for activity analysis and will include all randomized subjects with baseline and treatment data. Per protocol, the safety analysis sets are described below in statistical methods.

A subpopulation of 60 participants will also have additional PK and Immunogenicity blood samples collected. For this subgroup, PK and Immunogenicity samples will be collected at all study visits.

Conditions

Interventions

DRUG

DAS181-F02 formulation

DRUG

DAS181-F04 formulation

DRUG

Placebo

Sponsors & Collaborators

  • Ansun Biopharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01740063 on ClinicalTrials.gov