Phase 1 PK Study of XOMA 3AB

Summary

This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the 24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in which they will receive a single intravenous infusion of active drug or placebo. Placebo will be normal saline. Volunteers will be followed for safety for up to 120 days after infusion depending on dose cohort.

Timeline

Start

2011-05

Primary completion

2012-05

Completion

2013-05

Publications

• Background Nayak SU, Griffiss JM, McKenzie R, Fuchs EJ, Jurao RA, An AT, Ahene A, Tomic M, Hendrix CW, Zenilman JM. Safety and pharmacokinetics of XOMA 3AB, a novel mixture of three monoclonal antibodies against botulinum toxin A. Antimicrob Agents Chemother. 2014 Sep;58(9):5047-53. doi: 10.1128/AAC.02830-14. Epub 2014 Jun 9.

Drugs

Indications