NCT01924793

An Open Label Study to Examine the Effects of DAS181 Administered by Dry Powder Inhaler (DPI) or Nebulized Formulation in Immunocompromised Subjects With Parainfluenza (PIV) Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Ansun Biopharma, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with parainfluenza infection. All subjects will have additional PK and Immunogenicity blood samples collected.

Detailed description

The study will investigate the safety, tolerability, clinical and virologic effect of DAS1814 for the treatment of PIV infections in up to 60 immunocompromised patients with no other treatment options. Eligible immunocompromised patients positively diagnosed with PIV infection will receive DAS181 by DPI or Nebulized formulation. DPI: 10 mg DAS181 will be administered for seven (7) consecutive days for up to a total cumulative dose of 70mg. Nebulized: DAS181 F02 formulation in solution will be administered for seven (7) consecutive days for up to a total cumulative dose of 28.9 mg. Assessment of viral shedding and viral resistance testing will be performed on collected viral load samples. Blood samples will be obtained to evaluate safety at each scheduled visit. Routine safety monitoring (including Adverse Event (AE) reporting, clinical laboratory tests, vital signs, electrocardiogram (ECG) and )2 levels) will be conducted in all subjects. A final safety assessment will occur at Day 28 (+/- 2 days) after enrollment/first dose of study drug. Survival, diary cards, and quality of life will be collected at Day 60 and 90. PK will be collected at each visit on all subjects from baseline/visit 2 to visit 11/Day 28. Immunogenicity samples will be collected at selected time points in all subjects.

Conditions

• Parainfluenza

Interventions

Type	Name	Description
DRUG	DAS181-F02 Dry Powder in Bulk	Administered via DPI
DRUG	DAS181-F02 Nebulized Formulation Inhaled Dose	Administered via Nebulizer

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2013-08-19
• Last updated: 2017-07-19

Locations

23 sites across 1 country: United States