Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)

Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers

The purpose of this study is to determine the safety and tolerability of the anti-TSG101 human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.

Primary -

- To compare the safety profile of a single intravenous administration of FGI-101-1A6 as compared with Placebo

Secondary

• To evaluate the pharmacokinetics (PK) of a singel intravenous administration of FGI-101-1A6
• To evaluate the immunogenicity of FGI-101-1A6

Inclusion Criteria:

• Healthy volunteers ages 18-45
• Normal laboratory (blood tests) results

Exclusion Criteria:

• Prior immunization with live-attenuated vaccines