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

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:

• Cough
• Sore throat
• Wheezing
• Sneezing
• Shortness of breath
• Nasal congestion
• Earache
• Pleuritic chest pain
• At least one constitutional symptom:

• Headache
• Myalgia (body aches and pains)
• Fever or feverish (sweat/chills)
• Prostration (fatigue, tired, lacking energy)
• 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:

• the time when the temperature was first measured as elevated (38 C) OR
• the time when the subject experienced the presence of at least one symptom, whichever occurs first 11. Female subjects must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods may include intrauterine device, spermicide, barrier and hormonal contraception. A female subject must agree to practice an acceptable method of birth control during the study period. All female subjects regardless of menopausal status or surgical history must have had a negative urine pregnancy test during the screening visit and prior to dosing.

• Male subjects must agree to use medically accepted form of contraception during the study period.

Exclusion criteria

• Have received any investigational drug or investigational vaccine within 8 weeks prior to study drug dosing.
• Have had a serious adverse reaction or previous episode of anaphylaxis related to any drug.
• Have received blood products within 6 months of study enrollment.
• Have concurrent cystic fibrosis or emphysema.
• Have sickle cell disease.
• Known IGE mediated allergic response to lactose (not lactose intolerance).
• Any history of congenital or acquired bleeding abnormalities.
• Existence of any surgical, medical, or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug.
• Use of antiviral influenza medications within 10 days prior to screening (Subjects will be prohibited from taking antiviral influenza medications during the course of the trial).
• Current clinical evidence of a recognized or suspected uncontrolled non-influenza infectious illness with onset prior to screening.
• Known hypersensitivity to DAS181.
• Women who are pregnant (urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding.
• Uncontrolled seizure disorder or history of seizure activity within 12 months prior to study participation.
• Any significant findings in the subject's medical history or physical examination that, in the opinion of the investigator, would affect subject safety or compliance with the dosing schedule.
• Subjects with history of asthma or chronic obstructive pulmonary disease (COPD) requiring the use of acute or chronic medication in the past 3 years.
• Subjects with acute diagnosis of a chronic medical condition within the last 3 months.
• Subjects with a chronic medical condition that have initiated or changed dosing or regimen of prescription medications to treat the chronic medical condition within the last 3 months. (Any changes in chronic medications during the 28 day enrollment period will be captured in the source documentation under concomitant medications).
• Subjects with current or previous history of the following: systemic disorders, immunological disorders, hepatitis B virus (HBV), hepatitis C virus (HCV) or cirrhosis, transplant recipients, or other immunosuppressive illness.
• Subjects with cancer or history of hematologic malignancy. Cancer is defined as any active neoplastic diseases excluding noninvasive basal cell carcinoma.
• Subjects who have had or are scheduled to have surgery within 30 days of initiation of the study.
• Subjects who have donated or lost more than 500 mL of blood in the two months prior to screening.
• Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
• Family members of site staff directly involved in study conduct are excluded from study participation.
• Subjects with an oxygen saturation (Sa02) level of <92% as measured by pulse oximeter.
• Subjects with a modified CURB-65 score of 2 or higher.