NCT01740063

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

Randomized, Double-blind, Placebo-controlled Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 423 (actual)
• Sponsor: Ansun Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Influenza

Interventions

Type	Name	Description
DRUG	DAS181-F02 formulation
DRUG	DAS181-F04 formulation
DRUG	Placebo

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-12-04
• Last updated: 2019-07-08

Locations

1 site across 1 country: United States