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

• Status: Unknown status
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Functional Genetics Inc.
• Collaborator: United States Department of Defense
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• Healthy volunteers ages 18-45

• Normal laboratory (blood tests) results

Exclusion Criteria:

• Prior immunization with live-attenuated vaccines