A Study to Evaluate the Safety and Tolerability of Raxibacumab in Healthy Subjects

A Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Raxibacumab (Human Monoclonal Antibody to B. Anthracis Protective Antigen) in Healthy Subjects

To evaluate the safety and tolerability of raxibacumab in healthy subjects.

Key Inclusion Criteria:

• Male or female, 18 years of age or older
• Normal laboratory (blood test) results
• Subjects are eligible to enter the study if they are not pregnant or nursing, are sterile or of non-childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study (about 2 months)

Key Exclusion Criteria:

• History of significant, acute or chronic diseases (ie, heart, lung, gastrointestinal, liver, kidney, neurological or infectious diseases).
• Prior immunization with anthrax vaccine adsorbed (AVA), prior treatment with investigational anthrax therapies, prior treatment for anthrax exposure, or prior anthrax infection.
• History of Type I hypersensitivity reaction to food or drugs, IV contrast agents, antihistamines, or history of hives.
• A current drug or alcohol addiction.
• Positive for human immunodeficiency virus (HIV-1), Hepatitis B surface antigen, or Hepatitis C antibody.
• Cancer within the last 5 years (with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix).
• Participation within 60 days of intiating study or refusal to refrain from participation during the study in any other clinical trials of an investigational compound.
• Previous exposure to raxibacumab.