NCT02341508

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

A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Lpathomab Administered Intravenously to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Lpath, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
BIOLOGICAL	0.5 mg/kg Lpathomab
BIOLOGICAL	1.0 mg/kg Lpathomab
BIOLOGICAL	3.0 mg/kg Lpathomab
BIOLOGICAL	10 mg/kg Lpathomab
BIOLOGICAL	20 mg/kg Lpathomab
OTHER	Saline solution for intravenous infusion

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-01-19
• Last updated: 2016-05-06

Locations

1 site across 1 country: United States