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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation of DAS181-F02 Dry Powder in Bulk | Experimental | The DAS181-F02 nebulized formulation includes 10mL of normal saline to prepare a liquid solution referred to as DAS181-F02 nebulized. Dry Powder Inhaled Dose: Non-ventilated subjects, capable of using a cyclohaler, will be treated by Dry Powder Inhalation. Each subject will receive a targeted daily dose of 10mg for 7 days for a total of 70mg of DAS181-F02. If a subject requires ventilation, the subject will be allowed to continue dosing following the Nebulized formulation instruction. |
|
| Nebulized Formulation Inhaled Dose | Experimental | Subjects unable to use the Dry Powder Inhaler (as determined by site Investigator) on continuous positive airway pressure (CPAP), Bi-level positive airway pressure (BIPAP) or requiring mechanical ventilation will be treated by Nebulized formulation. The subject will remain on the nebulized formulation for the duration of the study regardless of ventilation status. DAS-F02 10 mg will be utilized to prepare the nebulized solution per the Study Reference Manual. Multiple methods (T piece, face mask, direct to ET tube) will be allowed for the nebulized dose administration. Detailed specification for nebulized dose administration will be defined in the Study Reference Manual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAS181-F02 Dry Powder in Bulk | Drug | Administered via DPI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with PIV viral load reduction at Day 28 | 2 years |
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Inclusion Criteria:
Age ≥12 years
Able to provide informed consent or child assent with parental consent
Immunocompromised, as defined by one of the following:
Confirmed Parainfluenza virus by nasopharyngeal swab or tracheal aspirate for one of the following:
Female subjects of child-bearing potential who are capable of conception must be:
post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject must agree to practice two acceptable methods of birth control during the 28 day study period. Abstinence is not an acceptable method of contraception. All reproductive female subjects must have a negative serum pregnancy test during the screening visit.
Male subjects must agree to use medically accepted form of contraception during the 28 day study period.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Moss, MD, CEO | Ansun Biopharma, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Children's Hospital of Orange County |
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| DAS181-F02 Nebulized Formulation Inhaled Dose |
| Drug |
Administered via Nebulizer |
|
| Orange |
| California |
| 92868 |
| United States |
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana Blood and Marrow Transplantation | Indianapolis | Indiana | 42367 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| John Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Minnesota, School of Medicine | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medical College/New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Weill Cornell Medical College-Peds | New York | New York | 10065 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Fred Hutchinson Cencer Research Center | Seattle | Washington | 98109-1024 | United States |
| ID | Term |
|---|---|
| D018184 | Paramyxoviridae Infections |
| ID | Term |
|---|---|
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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