MedTrace Logo

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

NCT02341508 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-05-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lpath, Inc.

    lead INDUSTRY

Principal Investigators

  • Dario A Paggiarino, MD · Lpath, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02341508 on ClinicalTrials.gov