Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers

Primary:

• To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo

Secondary:

• To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9
• To evaluate the immunogenicity of AVP-21D9

This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.

Key Inclusion Criteria:

• Healthy volunteers, between 18 and 45 years of age
• Normal laboratory (blood test) results

Key Exclusion Criteria:

• Prior immunization with anthrax vaccine