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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAS181-F02 formulation | Experimental | DAS181 10 mg dose for three days of the F02 formulation |
|
| DAS181-F04 formulation | Experimental | DAS181 20 mg dose group for three days of the F04 formulation, |
|
| Placebo | Placebo Comparator | placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAS181-F02 formulation | Drug |
| ||
| DAS181-F04 formulation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Unacceptable Serious Adverse Events due to safety and toxicity Safety and toxicity profile: Unacceptable Serious Adverse Events Safety and toxicity profile: Unacceptable Serious Adverse Events | Because of the possibility of unacceptable or excessive defined serious adverse events during the treatment period or the study enrollment period, a stopping rule for safety/tolerability has been introduced in the design. The following two stopping rule criteria will initiate an ad hoc DSMB data evaluation.
Changes (absolute and percent) from baseline in influenza viral load from Day 1 to Day 2 as measured by quantitative polymerase chain reaction (qPCR) from pharyngeal wash and nasal wash samples. | Participants will be followed (up to one year) for the duration of the study and outcome measure will be reviewed at the end of study. The expected end of study is Sept. 2013. |
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Inclusion Criteria:
Male and female subjects in generally good health in the opinion of the investigator as determined by vital signs, medical history, and a physical exam based on medical history.
Subjects must be able to verbalize understanding of the consent form, provide written informed consent and verbalize willingness to complete study procedures.
Be 18 to 70 years of age (inclusive).
Subjects must weigh at least 50 kg and must have a Body Mass Index (BMI) of no greater than 40.00.
Febrile, oral temperature ≥100.4°F (≥38.0°C) in combination with symptoms
At least one respiratory symptom:
At least one constitutional symptom:
Positive rapid antigen test (RAT) for influenza performed using FDA-cleared and CLIA-waived commercially available rapid antigen test supplied by the sponsor.
Blood pressure within normal limits (systolic 90-150 mmHg; diastolic 50-95 mmHg) and heart rate between 45 and 140 beats per minute.
Onset of symptoms no more than 48 hours prior to diagnosis.
Note: Time of onset of illness is defined as either:
12. Male subjects must agree to use medically accepted form of contraception during the study period.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nexbio | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Drug |
|
| Placebo | Drug |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |