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

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

Timeline

Start

2010-08

Primary completion

2011-06

Completion

2011-06

Publications

• Malkevich NV, Hopkins RJ, Bernton E, Meister GT, Vela EM, Atiee G, Johnson V, Nabors GS, Aimes RT, Ionin B, Skiadopoulos MH. Efficacy and safety of AVP-21D9, an anthrax monoclonal antibody, in animal models and humans. Antimicrob Agents Chemother. 2014 Jul;58(7):3618-25. doi: 10.1128/AAC.02295-13. Epub 2014 Apr 14.

Drugs

Indications