Assessment of CR6261, a Monoclonal Antibody Against the Influenza A Virus

Inclusion Criteria:

1. Adult male and female subjects aged 18 to 50 years.
2. Body mass index between 18 and 30, body weight between 50 and 100 kg.
3. Has acceptable blood pressure and heart rate parameters within the normal limits.
4. Healthy as determined by pre-study medical history, physical examination, and 12 lead electrocardiogram.
5. All routine safety labs must be within protocol-specified normal limits.
6. Able and willing to give written informed consent.
7. Has the ability to complete the follow-up period of 75 days.
8. Subjects must agree to abstain from alcohol intake 24 hours before administration of study drug, during the inpatient period and 24 hours prior to all other outpatient clinic visits.
9. Subjects must agree to not use over the counter medications and herbal medication, within 14 days prior to study drug administration through the final follow-up visit.

10. Female subjects must:

    • Be surgically sterile, or
    • If heterosexually active, use two effective methods of birth control, or
    • Confirm male partner sterilization, or
    • Not be heterosexually active
11. Females must have a negative urine pregnancy test at both screening and baseline.
12. If a man who is able to father a child and sexually active with a female of childbearing potential, he must agree to use a double barrier method of birth control and to not donate sperm during the study.
13. Subjects must agree to avoid strenuous exercise while confined to the Clinical Unit and for at least 72 hours prior to study drug administration and follow up visits.

Exclusion Criteria:

1. Acute illness at the time of entry into the study.
2. Temperature >99.5°F (37.5°C) at randomization.
3. Presence of a significant infection or known inflammatory process.
4. Presence of acute gastrointestinal symptoms.
5. A diagnosis of influenza infection or any constellation of clinical symptoms consistent with influenza infection.
6. Received any live virus or bacterial vaccinations within 3 months prior to screening or are expected to receive any live virus or bacterial vaccinations during the study.
7. Received inactivated influenza vaccines within 2 weeks of Study Day 1 or are expected to receive an inactivated influenza vaccine during the study.
8. Any chronic condition requiring prescription or over-the-counter medicine, with the exception of vitamins.
9. Chronic administration of immunosuppressants or other immune modifying drugs within 6 months before administration of the investigational product.
10. Antibiotic therapy within 7 days before Study Day 1.
11. History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorders.
12. Previous medical history that may compromise the safety of the subject in the study.
13. Positive serology for the human immunodeficiency virus (HIV) 1 or 2 antibody, hepatitis C virus antibody or hepatitis B surface antigen.
14. History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
15. Known or suspected hypersensitivity to any CR6261 excipients.
16. A history of alcohol or drug abuse within the past 2 years.
17. Positive urine test for illicit drugs.
18. Subjects who report current tobacco use of more than 10 cigarettes or 2 cigars per day.
19. Receipt of any other investigational product within 1 month or 5 half-lives before administration of the study investigational product.
20. Participation in any clinical study involving receipt of investigational product, blood or blood products, or donation of blood throughout the duration of the study.
21. Received antibody or biologic therapy.
22. Subjects who have donated and/or received any blood or blood products within 3 months before administration of the study investigational product or planned donation/receipt throughout the course of the study.
23. Subjects who cannot communicate reliably with the investigator.
24. Any condition that in the opinion of the investigator, may complicate or compromise the study, or the well-being of the subject.
25. Employee at the clinic, or spouse/relative of the investigator or employees.
26. Has experienced an anaphylactic reaction to latex.
27. Have currently or a past history of thrombocytopenia or bleeding abnormality.
28. Is unable or unwilling to undergo multiple venipunctures.
29. Female subjects who are breastfeeding.
30. Drinks more than 1200 mL of tea/coffee/cocoa/cola or other caffeinated beverage per day more than one day per week in the 2 weeks before screening.