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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Emergent BioSolutions
• Collaborator: National Institutes of Health (NIH)
• Treatments: Antibodies; Antibodies, Monoclonal

Criteria

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