drugset / Trial / NCT00110591

Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

NCT00110591 ↗

Phase 1 Completed 20 enrolled CytoDyn, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion. Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum.

Timeline

Start
2004-04-16
Primary completion
2005-11-07
Completion
2008-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Leronlimab Monoclonal antibody 0.1 mg/kg Intravenous
Subject Leronlimab Monoclonal antibody 0.5 mg/kg Intravenous
Subject Leronlimab Monoclonal antibody 2 mg/kg Intravenous
Subject Leronlimab Monoclonal antibody 5 mg/kg Intravenous