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Safety and Bioavailability of IV and SC LBR-101

NCT01991509 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-03-04

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101 when administered intravenously or subcutaneously to healthy volunteers.

Conditions

  • Bioavailability and Pharmacokinetics

Interventions

BIOLOGICAL

LBR-101 IV

LBR-101 Administered Intravenously

BIOLOGICAL

LBR-101 SC

LBR-101 Administered Subcutaneously

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Marcelo Bigal, MD, PhD · Sponsor Chief Medical Officer

  • Rafael Escandon, PhD MPH · Sponsor Clinical VP

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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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 NCT01991509 on ClinicalTrials.gov