Safety Study of Ch-mAb7F9 for Methamphetamine Abuse

Summary

The primary objective is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.Phase 1a, randomized, placebo-controlled, first-in-human (FIH) study of intravenously administered ch-mAb7F9. The study will be a double-blind, dose-escalation study. Each subject will receive a single dose of ch-mAb7F9 or placebo (saline).

Timeline

Start

2012-04

Primary completion

2013-07

Completion

2013-07

Publications

• Harris AC, LeSage MG, Shelley D, Perry JL, Pentel PR, Owens SM. The anti-(+)-methamphetamine monoclonal antibody mAb7F9 attenuates acute (+)-methamphetamine effects on intracranial self-stimulation in rats. PLoS One. 2015 Mar 5;10(3):e0118787. doi: 10.1371/journal.pone.0118787. eCollection 2015.

Drugs

Indications