drugset
drugset / Trial / NCT02341508

A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers

NCT02341508 ↗

Phase 1 Completed 36 enrolled Lpath, Inc.
RandomizedSingle-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to evaluate the safety and tolerability of Lpathomab in healthy volunteers. Additional endpoints include characterization of the pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity profiles of a single IV dose of Lpathomab in healthy volunteers.

Timeline

Start
2015-09
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Lpathomab Unknown 0.5 mg/kg Intravenous
Subject Lpathomab Unknown 1 mg/kg Intravenous
Subject Lpathomab Unknown 3 mg/kg Intravenous
Subject Lpathomab Unknown 10 mg/kg Intravenous
Subject Lpathomab Unknown 20 mg/kg Intravenous

Indications

No indication recorded.